Diabetes Mellitus, Type 2Phase 2/3NCT00734474
A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
A Phase 2/3 study testing LY2189265, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 99 sites in 13 countries.
Trial summary
This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2189265, Sitagliptin and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,202 participants
- Where
- 99 sitesin 13 countries
- Study dates
- Aug 2008to Jul 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, type 2, for at least 6 months
- Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.
- Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of >8.0% to ≤9.5%
- Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m^2), inclusive
- Stable weight for 3 months prior to screening
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Who cannot join
- Diabetes mellitus, type 1
- Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
- Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility
- Use of medications to promote weight loss
- Clinically-relevant cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension
Show all 15Show fewer
- Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease
- Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels >3.0 times the upper limit of normal
- Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance <60 milliliters per minute (mL/minute)
- Uncontrolled diabetes, defined as >2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.
- Uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ
- Chronic use of systemic glucocorticoid therapy
- Active or untreated malignancy
- Use of central nervous system (CNS) stimulants
Trial locations and contacts
99 sites in 13 countries.
99 sites in 13 countries
United States35 sites
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Ann Arbor, Michigan, 48106
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Athens, Georgia, 30606
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Atlanta, Georgia, 30303
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Biddeford, Maine, 04005
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Billings, Montana, 59101
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Charleston, South Carolina, 29412
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Corvallis, Oregon, 97330
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Dallas, Texas, 75230
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Federal Way, Washington, 98003
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Fresno, California, 93726
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Georgetown, Texas, 78626
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Greensboro, North Carolina, 27401
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Hollywood, Florida, 33021
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Houston, Texas, 77030
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Idaho Falls, Idaho, 83404
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Las Vegas, Nevada, 89101
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Longmont, Colorado, 80501
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Metairie, Louisiana, 70006
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Mission Hills, California, 91345
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Morehead City, North Carolina, 28557
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Peoria, Arizona, 85381
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Phoenix, Arizona, 85050
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Rochester, New York, 14607
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Saint Clair Shores, Michigan, 48081
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San Antonio, Texas, 78229
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Southfield, Michigan, 48075
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Springfield, Illinois, 62704
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St Louis, Missouri, 63141
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Topeka, Kansas, 66606
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Tucson, Arizona, 85741
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Waterbury, Connecticut, 06708
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West Palm Beach, Florida, 33401
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Winston-Salem, North Carolina, 27103
Germany12 sites
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Aschaffenburg, 63739
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Bad Lauterberg im Harz, D-37431
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Bad Staffelstein, D-96231
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Bochum, D-44791
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Essen, 45355
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Hamburg, 21073
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Hirschhorn, 69434
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Mainz, D-55116
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Münster, 48145
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Neuwied, 56564
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Pohlheim, D-35415
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Rotenburg-Fulda, 36199
France9 sites
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Corbeil-Essonnes, 91106
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La Rochelle, 17019
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Mantes-la-Jolie, 78200
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Montpellier, F-34295
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Narbonne, 11108
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Saint-Mandé, 94160
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Strasbourg, 67000
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Toul, 54201
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Vénissieux, 69200
Taiwan7 sites
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Chiayi City, 600
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Kaohsiung City, 807
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Taichung, 40201
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Taichung, 407
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Tainan, 70403
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Taipei, 100
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Yung-Kang, Tainan, 710
India5 sites
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Ahmedabad, 380006
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Bangalore, 560038
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Ghaziabad, 201 002
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Kochi, 682026
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Pune, 411005
Poland5 sites
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Gdynia, 81-557
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Lodz, 93-319
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Lublin, 20-954
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Szczecin, 70-506
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Wroclaw, 50-403
South Korea5 sites
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Goyang-si, 410-719
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Incheon, 400-711
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Seongnam-si, 463-707
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Seoul, 139-872
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Sungnam-Si, 463-712
Spain5 sites
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Dos Hermanas, 41014
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Lleida, 25198
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Málaga, 29010
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Palma de Mallorca, 07010
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Pozuelo de Alarcón, 28223
Canada4 sites
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Calgary, Alberta, T2H 2G4
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Oakville, Ontario, L6H 3P1
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Sherbrooke, Quebec, J1G 5K2
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Winnipeg, Manitoba, R3P 3P4
Mexico4 sites
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Aguascalientes, 20129
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Chihuahua City, 31238
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Guadalajara, 44600
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Monterrey, 64461
Romania3 sites
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Baia Mare, 430123
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Cluj-Napoca, 400006
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Timișoara, 300736
Russia3 sites
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Arkhangelsk, 163045
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Rostov-on-Don, 344022
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Saint Petersburg, 193257
Puerto Rico2 sites
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Manati, 00674
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San Juan, 00907
About this study
Official title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.
Read the detailed description
This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to 26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3 portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c) at 52 weeks. The final endpoint is 104 weeks.
Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2189265, Sitagliptin, Placebo solution, Placebo tablet, Metformin
- Keywords
- Diabetes, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2189265Drug
Also called Dulaglutide, Trulicity
SitagliptinDrug
Placebo solutionDrug
Placebo tabletDrug
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| 3.0 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 2.0 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 1.5 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 1.0 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 0.75 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 0.5 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| 0.25 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks Receives: Drug: LY2189265; Drug: Placebo tablet; Drug: Metformin |
| Sitagliptin | Active comparator | Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks Receives: Drug: Sitagliptin; Drug: Placebo solution; Drug: Metformin |
| Placebo/Sitagliptin (Baseline Through 104 Weeks) | Placebo comparator | Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks Receives: Drug: Placebo solution; Drug: Placebo tablet; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 52 weeks
Secondary outcomes (30)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point
Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.
Measured: Baseline up to 27.4 weeks
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 26 weeks, 104 weeks
Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 13, 26, 52, and 104 weeks
Fasting Blood Glucose Change From Baseline
Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 104 weeks
Fasting Insulin Change From Baseline
Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 104 weeks
Change From Baseline in Body Weight at Dose Decision Point
Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.
Measured: Baseline up to 27.4 weeks
Body Weight Change From Baseline
Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 104 weeks
Durability of Change From Baseline Body Weight
Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 13, 26, 52, and 104 weeks
Waist Circumference Change From Baseline
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 104 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.
Measured: Baseline, 26, 52, and 104 weeks
Incidence of Hypoglycemic Episodes
Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.
Measured: Baseline through 26 and 104 weeks
Rate of Hypoglycemic Episodes
Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.
Measured: Baseline through 26 and 104 weeks
Beta Cell Function and Insulin Sensitivity (HOMA2)
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 104 weeks
Number of Participants With Treatment-emergent Adverse Events at 26 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 weeks
Number of Participants With Treatment-emergent Adverse Events at 52 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Number of Participants With Treatment-emergent Adverse Events at 104 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 104 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks
The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).
Measured: Baseline through 26 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks
The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .
Measured: Baseline through 52 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks
The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).
Measured: Baseline through 104 weeks
Number of Participants With Treatment-emergent Abnormal Lipid Tests
The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.
Measured: Baseline through 26 and 104 weeks
Change From Baseline in Pulse Rate at Dose Decision Point
Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.
Measured: Baseline up to 27.4 weeks
Change From Baseline in Blood Pressure at Dose Decision Point
Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.
Measured: Baseline up to 27.4 weeks
Change From Baseline in Pulse Rate
Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.
Measured: Baseline, 26 weeks, 104 weeks
Change From Baseline in Blood Pressure
Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks, 104 weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks, 104 weeks
Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)
The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants' quality of life. Items are scored on a 5-point numeric rating scale where 5 = "always true" and 1 = "never true". Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.
Measured: Baseline, 52 weeks, and 104 weeks
Participant-reported Outcomes, EQ-5D
The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline, 52 weeks, and 104 weeks
Resource Utilization
The number of visits to the emergency room (ER) is summarized cumulatively.
Measured: Baseline through 52 and 104 weeks
Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve
Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.
Measured: Baseline through 52 weeks
Antibodies to LY2189265
The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.
Measured: Baseline through 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC, Tessella Inc., Berry Consultants
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734474
- Sponsor's protocol ID
- 11422
- Other IDs
- H9X-MC-GBCF, CTRI/2009/091/000969
- Status last verified
- Mar 2015
- First submitted
- 12 Aug 2008
- Last updated
- 20 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
PubMed 36894938Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.
PubMed 28755389Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
PubMed 27161178Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
PubMed 26691396Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.
PubMed 25912221Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.
PubMed 24762094Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.
PubMed 23294774
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
- ClinicalTrials.gov ID
- NCT00734474
- Acronym / sponsor ID
- 11422
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, type 2 diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC, Tessella Inc., Berry Consultants
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 28 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.
Detailed description
This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to 26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3 portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c) at 52 weeks. The final endpoint is 104 weeks.
Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 3.0 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 2.0 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 1.5 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 1.0 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 0.75 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 0.5 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| 0.25 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Placebo tablet, Drug: MetforminLY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks Placebo: tablet, administered orally, once daily for up to 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks |
| Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: Placebo solution, Drug: MetforminSitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks |
| Placebo/Sitagliptin (Baseline Through 104 Weeks) | Placebo comparator | Drug: Placebo solution, Drug: Placebo tablet, Drug: MetforminPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks Placebo: tablet, administered orally, once daily for 26 weeks Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus, type 2, for at least 6 months
- Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.
- Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of >8.0% to ≤9.5%
- Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m^2), inclusive
- Stable weight for 3 months prior to screening
Key exclusion criteria (15 listed)
- Diabetes mellitus, type 1
- Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
- Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility
- Use of medications to promote weight loss
- Clinically-relevant cardiovascular event within 6 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2189265Also: Dulaglutide, Trulicity | Drug | 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265 |
| Sitagliptin | Drug | Sitagliptin |
| Placebo solution | Drug | Placebo/Sitagliptin (Baseline Through 104 Weeks), Sitagliptin |
| Placebo tablet | Drug | 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265, Placebo/Sitagliptin (Baseline Through 104 Weeks) |
| Metformin | Drug | 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265, Placebo/Sitagliptin (Baseline Through 104 Weeks), Sitagliptin |
Primary outcome
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame: Baseline, 52 weeks
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.
30 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point
Time frame: Baseline up to 27.4 weeks
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame: Baseline, 26 weeks, 104 weeks
Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 13, 26, 52, and 104 weeks
Fasting Blood Glucose Change From Baseline
Time frame: Baseline, 26, 52, and 104 weeks
Fasting Insulin Change From Baseline
Time frame: Baseline, 26, 52, and 104 weeks
Change From Baseline in Body Weight at Dose Decision Point
Time frame: Baseline up to 27.4 weeks
Body Weight Change From Baseline
Time frame: Baseline, 26, 52, and 104 weeks
Durability of Change From Baseline Body Weight
Time frame: Baseline, 13, 26, 52, and 104 weeks
Waist Circumference Change From Baseline
Time frame: Baseline, 26, 52, and 104 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Time frame: Baseline, 26, 52, and 104 weeks
Incidence of Hypoglycemic Episodes
Time frame: Baseline through 26 and 104 weeks
Rate of Hypoglycemic Episodes
Time frame: Baseline through 26 and 104 weeks
Beta Cell Function and Insulin Sensitivity (HOMA2)
Time frame: Baseline, 26, 52, and 104 weeks
Number of Participants With Treatment-emergent Adverse Events at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Participants With Treatment-emergent Adverse Events at 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants With Treatment-emergent Adverse Events at 104 Weeks
Time frame: Baseline through 104 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks
Time frame: Baseline through 104 weeks
Number of Participants With Treatment-emergent Abnormal Lipid Tests
Time frame: Baseline through 26 and 104 weeks
Change From Baseline in Pulse Rate at Dose Decision Point
Time frame: Baseline up to 27.4 weeks
Change From Baseline in Blood Pressure at Dose Decision Point
Time frame: Baseline up to 27.4 weeks
Change From Baseline in Pulse Rate
Time frame: Baseline, 26 weeks, 104 weeks
Change From Baseline in Blood Pressure
Time frame: Baseline, 26 weeks, 104 weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval
Time frame: Baseline, 26 weeks, 104 weeks
Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)
Time frame: Baseline, 52 weeks, and 104 weeks
Participant-reported Outcomes, EQ-5D
Time frame: Baseline, 52 weeks, and 104 weeks
Resource Utilization
Time frame: Baseline through 52 and 104 weeks
Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve
Time frame: Baseline through 52 weeks
Antibodies to LY2189265
Time frame: Baseline through 104 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36894938Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
- Derived from this study: PubMed 28755389Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.
- Derived from this study: PubMed 27161178Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
- Derived from this study: PubMed 26691396Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
- Derived from this study: PubMed 25912221Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.
- Derived from this study: PubMed 24762094Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.
- Derived from this study: PubMed 23294774Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.
- (Lilly Clinical Trial Registry)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study chair
Eli Lilly and Company
99 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LY2189265, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 99 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, Germany, France, Taiwan, India and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin (HbA1c) Change From Baseline (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00734474, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.