Diabetes Mellitus, Type 2Phase 2NCT00791479
Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
A Phase 2 study testing LY2189265 and Lifestyle Measures in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 46 sites in 9 countries.
Trial summary
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus. 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 and Lifestyle Measures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 46 sitesin 9 countries
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 2
- 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
- Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
- Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
- Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
- Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.
- Stable weight for 3 months prior to screening
Who cannot join
- Diabetes mellitus, type 1
- Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
- Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
- Use of medications (prescription or over-the counter) to promote weight loss
- Chronic (>2 weeks) use of systemic glucocorticoid therapy
- Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
Show all 24Show fewer
- Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release [SR])
- Cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
- Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
- Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
- Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
- Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
- Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance <60 milliliter (mL)/minute which are determined by central labs at the time of screening
- Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
- Significant active, uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ (corneal transplants are allowed)
- Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
- Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
- Sponsor employees
- Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
- Have previously completed or withdrawn from this study after providing informed consent
Trial locations and contacts
46 sites in 9 countries.
46 sites in 9 countries
United States12 sites
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Beaver, Pennsylvania, 15009
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Bloomfield Hills, Michigan, 48302
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Calabash, North Carolina, 28467
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Concord, California, 94520
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Lancaster, California, 93534
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Menomonee Falls, Wisconsin, 53051
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Mission Hills, California, 91345
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North Myrtle Beach, South Carolina, 29582
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Palm Springs, California, 92262
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Tabor City, North Carolina, 28463
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Vincennes, Indiana, 47591
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Wichita, Kansas, 67208
India7 sites
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Bangalore, 560052
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Bilāspur, 495006
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Hyderabaad, 500001
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Indore, 452001
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Kochi, 682026
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Mumbai, 400 067
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New Delhi, 110 029
Denmark6 sites
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Aalborg, DK-9000
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Aarhus, 8000
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Copenhagen, 2300
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Copenhagen, 2400
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Frederiksberg, 2000
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Hillerød, Dk-3400
Spain6 sites
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Alzira, 46600
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Dos Hermanas, 41014
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Lleida, 25198
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Málaga, 29010
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Santa Cruz de Tenerife, 38320
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Torrevieja, 03186
Croatia4 sites
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Dubrovnik, 20000
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Osijek, HR-31000
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Varaždin, HR-42000
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Zagreb, HR-10000
Russia4 sites
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Arkhangelsk, 163045
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Moscow, 119881
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Rostov-on-Don, 344022
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Saint Petersburg, 193257
Poland3 sites
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Bialystok, 15-950
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Szczecin, 71-252
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Wroclaw, 503-349
Mexico2 sites
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Mexico City, 06700
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Monterrey, 64570
Puerto Rico2 sites
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Carolina, 00983
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San German, 00685
About this study
Official title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
Read the detailed description
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2189265 and Lifestyle Measures, Placebo solution and Lifestyle Measures
- 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.
LY2189265 and Lifestyle MeasuresDrug
Also called Dulaglutide
Subcutaneous injection once-weekly for up to 12 weeks
Placebo solution and Lifestyle MeasuresDrug
Subcutaneous injection once-weekly for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.1 milligram (mg) LY2189265 | Experimental | LY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW) Receives: Drug: LY2189265 and Lifestyle Measures |
| 0.5 milligram (mg) LY2189265 | Experimental | LY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW) Receives: Drug: LY2189265 and Lifestyle Measures |
| 1.0 milligram (mg) LY2189265 | Experimental | LY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW) Receives: Drug: LY2189265 and Lifestyle Measures |
| 1.5 milligram (mg) LY2189265 | Experimental | LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) Receives: Drug: LY2189265 and Lifestyle Measures |
| Placebo | Placebo comparator | Placebo: subcutaneous (SC) once weekly (QW) Receives: Drug: Placebo solution and Lifestyle Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Measured: Baseline, 12 weeks
Secondary outcomes (16)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
Measured: Baseline, 4 weeks, 8 weeks
Change From Baseline in Fasting Blood Glucose
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
Measured: Baseline, 12 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
Measured: 12 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Beta-cell Function (HOMA2-%B)
Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify 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). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - 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. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Pulse Rate
Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Measured: Baseline, 12 weeks
Change From Baseline in Blood Pressure (BP)
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Measured: Baseline, 12 weeks
Number of Participants With Self-reported Hypoglycemic Events
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 12 weeks
Rate of Self-reported Hypoglycemic Events
Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
Measured: Baseline through 12 weeks
Treatment Emergent Adverse Events
A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 12 weeks
Change From Baseline in Body Weight
Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Measured: Baseline, 12 weeks
Antibody Production and Effects to LY2189265
LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
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 (1)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00791479
- Sponsor's protocol ID
- 12565
- Other IDs
- H9X-MC-GBCK, CTRI/2009/091/000105
- Status last verified
- Dec 2014
- First submitted
- 12 Nov 2008
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.
PubMed 22804250
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT00791479
- Acronym / sponsor ID
- 12565
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
Detailed description
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.1 milligram (mg) LY2189265 | Experimental | Drug: LY2189265 and Lifestyle MeasuresLY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW) |
| 0.5 milligram (mg) LY2189265 | Experimental | Drug: LY2189265 and Lifestyle MeasuresLY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW) |
| 1.0 milligram (mg) LY2189265 | Experimental | Drug: LY2189265 and Lifestyle MeasuresLY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW) |
| 1.5 milligram (mg) LY2189265 | Experimental | Drug: LY2189265 and Lifestyle MeasuresLY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) |
| Placebo | Placebo comparator | Drug: Placebo solution and Lifestyle MeasuresPlacebo: subcutaneous (SC) once weekly (QW) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes mellitus, type 2
- Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
- Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
- Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Key exclusion criteria (24 listed)
- Diabetes mellitus, type 1
- Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
- Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
- Use of medications (prescription or over-the counter) to promote weight loss
- Chronic (>2 weeks) use of systemic glucocorticoid therapy
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 |
|---|---|---|
| LY2189265 and Lifestyle MeasuresAlso: DulaglutideSubcutaneous injection once-weekly for up to 12 weeks | Drug | 0.1 milligram (mg) LY2189265, 0.5 milligram (mg) LY2189265, 1.0 milligram (mg) LY2189265, 1.5 milligram (mg) LY2189265 |
| Placebo solution and Lifestyle MeasuresSubcutaneous injection once-weekly for up to 12 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 12 weeks
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
16 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, 12 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Time frame: 12 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
Time frame: Baseline, 12 weeks
Change From Baseline in Beta-cell Function (HOMA2-%B)
Time frame: Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Time frame: Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
Time frame: Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
Time frame: Baseline, 12 weeks
Change From Baseline in Pulse Rate
Time frame: Baseline, 12 weeks
Change From Baseline in Blood Pressure (BP)
Time frame: Baseline, 12 weeks
Number of Participants With Self-reported Hypoglycemic Events
Time frame: Baseline through 12 weeks
Rate of Self-reported Hypoglycemic Events
Time frame: Baseline through 12 weeks
Treatment Emergent Adverse Events
Time frame: Baseline through 12 weeks
Change From Baseline in Body Weight
Time frame: Baseline, 12 weeks
Antibody Production and Effects to LY2189265
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
Time frame: 4 weeks, 8 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22804250Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.
- Related InfoLink 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
46 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2189265 and Lifestyle Measures in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 46 sites in 9 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 7 inclusion and 24 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, India, Denmark, Spain, Croatia and 4 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 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.
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 10 Dec 2014). 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?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 12 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 NCT00791479, which also lists 1 linked publication.
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 10 Dec 2014.