Type 2 Diabetes MellitusPhase 3NCT01894568
A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
A Phase 3 study testing Insulin Peglispro, Insulin Glargine and Oral Antihyperglycemic Medications (OAMs) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 31 sites in 3 countries.
Trial summary
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Peglispro, Insulin Glargine and Oral Antihyperglycemic Medications (OAMs)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Jul 2013to Apr 2015
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
- Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
- Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
- Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)
- Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
- Record keeping as required by this protocol
- Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product
Who cannot join
- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
- Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
- Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
- Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
Show all 17Show fewer
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
- Have cardiac disease with functional status that is New York Heart Association Class III or IV
- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter [μmol/L]). Participants taking metformin should not exceed the creatinine level specified in the local label
- Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or any chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
- Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening as determined by the central laboratory
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Japan18 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, 455-8530
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Chiba, 277-0825
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Fukuoka, 807-0857
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Hokkaido, 060-0062
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Hyōgo, 662-0971
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Ibaraki, 311-0113
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Kagawa, 765-0071
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Kanagawa, 247-0056
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Kumamoto, 862-0976
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Kyoto, 6150035
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Miyagi, 980-0021
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Miyazaki, 880-0034
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Nagano, 399-0006
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Ōita, 8700039
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Osaka, 569-1096
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Tochigi, 323-0022
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Tokyo, 143-8541
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Yamaguchi, 751-0815
Taiwan7 sites
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Sindian City, 23148
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Taichung, 404
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Taichung County, 433
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Tainan, 70403
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Taipei, 220
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Yongkang District, 71004
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Zhonghe, 235
South Korea6 sites
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Daegu, 700-712
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Incheon, 405-760
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Pusan, 602-739
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Seoul, 158-710
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Ulsan, 682-714
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Wŏnju, 220-701
About this study
Official title: A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Peglispro, Insulin Glargine, Oral Antihyperglycemic Medications (OAMs)
- 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.
Insulin PeglisproDrug
Also called LY2605541
Administered SC using a prefilled pen.
Insulin GlargineDrug
Administered SC using a prefilled pen
Oral Antihyperglycemic Medications (OAMs)Drug
Also called Sulfonylureas, Meglitinides, Dipeptidyl Peptidase-4 (DPP-IV) Inhibitors, Biguanides
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Insulin Peglispro | Experimental | Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs). Receives: Drug: Insulin Peglispro; Drug: Oral Antihyperglycemic Medications (OAMs) |
| Insulin Glargine | Active comparator | Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs. Receives: Drug: Insulin Glargine; Drug: Oral Antihyperglycemic Medications (OAMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
Measured: Baseline, Week 26
Secondary outcomes (17)
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (<3.9 micromoles per liter [mmol/L]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Measured: Baseline to Week 26
Fasting Serum Glucose (FSG)
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea [SU]/meglitinide use), visit, and treatment-by-visit interaction.
Measured: Weeks 0 and 26
Fasting Blood Glucose (FBG)
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
Measured: Weeks 0 and 26
Change From Baseline to Week 26 in Body Weight
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
Measured: Baseline, Week 26
9-Point Self-Monitored Blood Glucose (SMBG)
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.
Measured: Week 0 and Week 26
Percentage of Participants With HbA1c ≤6.5%
Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.
Measured: Week 26
Insulin Dose Per Kilogram (kg) of Body Weight
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.
Measured: Week 26
Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])
Measured: Week 26
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.
Measured: Week 26
Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26
For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.
Measured: Week 26
Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26
The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.
Measured: Baseline, Week 26
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.
Measured: Week 4 and 26
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.
Measured: Baseline, Week 26
Intra-Participant Variability of the Fasting Blood Glucose (FBG)
Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Measured: Week 26
Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Measured: Baseline, Week 12
Percent Hemoglobin A1c at Week 26
HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Measured: Week 26
Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)
Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
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.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 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 director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894568
- Sponsor's protocol ID
- 13422
- Other IDs
- I2R-JE-BIAQ
- Status last verified
- Mar 2019
- First submitted
- 3 Jul 2013
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01894568
- Acronym / sponsor ID
- 13422
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Peglispro | Experimental | Drug: Insulin Peglispro, Drug: Oral Antihyperglycemic Medications (OAMs)Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs). |
| Insulin Glargine | Active comparator | Drug: Insulin Glargine, Drug: Oral Antihyperglycemic Medications (OAMs)Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
- Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
- Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
- Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)
- Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
Key exclusion criteria (17 listed)
- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
- Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
- Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
- Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss
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 |
|---|---|---|
| Insulin PeglisproAlso: LY2605541Administered SC using a prefilled pen. | Drug | Insulin Peglispro |
| Insulin GlargineAdministered SC using a prefilled pen | Drug | Insulin Glargine |
| Oral Antihyperglycemic Medications (OAMs)Also: Sulfonylureas, Meglitinides, Dipeptidyl Peptidase-4 (DPP-IV) Inhibitors, BiguanidesAdministered orally | Drug | Insulin Glargine, Insulin Peglispro |
Primary outcome
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 26
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
17 secondary outcomes
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Time frame: Baseline to Week 26
Fasting Serum Glucose (FSG)
Time frame: Weeks 0 and 26
Fasting Blood Glucose (FBG)
Time frame: Weeks 0 and 26
Change From Baseline to Week 26 in Body Weight
Time frame: Baseline, Week 26
9-Point Self-Monitored Blood Glucose (SMBG)
Time frame: Week 0 and Week 26
Percentage of Participants With HbA1c ≤6.5%
Time frame: Week 26
Insulin Dose Per Kilogram (kg) of Body Weight
Time frame: Week 26
Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])
Time frame: Week 26
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
Time frame: Week 26
Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26
Time frame: Week 26
Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26
Time frame: Baseline, Week 26
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
Time frame: Week 4 and 26
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
Time frame: Baseline, Week 26
Intra-Participant Variability of the Fasting Blood Glucose (FBG)
Time frame: Week 26
Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12
Percent Hemoglobin A1c at Week 26
Time frame: Week 26
Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)
Time frame: Baseline to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 director
Eli Lilly and Company
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Peglispro, Insulin Glargine and Oral Antihyperglycemic Medications (OAMs) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 31 sites in 3 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 17 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan, Taiwan, South Korea. 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. 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 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 15 Mar 2019). 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 to Week 26 in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2019.