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Trial record 2 of 2 for:    LY2944876
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A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119819
Recruitment Status : Completed
First Posted : April 22, 2014
Results First Posted : April 14, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Description
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Brief Summary:
The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY2944876 Drug: Exenatide extended-release Drug: Placebo Drug: Metformin Phase 2

Detailed Description:
The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
Study Start Date : April 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 10 mg LY2944876

10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.

Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

 Drug: LY2944876
Administered SC

Drug: Metformin
Oral
Experimental: 15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
 Drug: LY2944876
Administered SC

Drug: Metformin
Oral
Experimental: 30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
 Drug: LY2944876
Administered SC

Drug: Metformin
Oral
Experimental: 50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
 Drug: LY2944876
Administered SC

Drug: Metformin
Oral
Experimental: Exenatide extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
 Drug: Exenatide extended-release
Administered SC

Drug: Metformin
Oral
Placebo Comparator: Placebo

Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.

Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

 Drug: Placebo
Administered SC

Drug: Metformin
Oral


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ]
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline, Week 24 ]
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

  2. Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
  3. Change From Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

  4. Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week (Wk) 12; Baseline, Week 24 ]
    SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

  5. Change From Baseline in Lipids [ Time Frame: Baseline, Week 24 ]
    Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect.

  6. Change From Baseline in Fasting Fibroblast Growth Factor 21 [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  7. Percentage of Participants Requiring Rescue Therapy [ Time Frame: Baseline through Therapy Completion (Week 24) ]
    Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin.

  8. Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 [ Time Frame: Week 12 and Week 24 ]
    Percentage of participants developing anti-drug antibodies to LY2944876.

  9. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876 [ Time Frame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 ]
    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

  10. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 [ Time Frame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 ]
    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

  11. Change From Baseline in Adiponectin Levels [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  12. Change From Baseline in Beta-Hydroxy Butyrate Levels [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  13. Change From Baseline in Glucagon Levels [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  14. Change From Baseline in Insulin Levels [ Time Frame: Baseline, Week 12; Baseline, Week 24 ]
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women with diabetes mellitus Type 2
  • Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
  • Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Exclusion Criteria:

  • Women of child bearing potential
  • Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
  • Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
  • Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119819


Locations
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Sponsors and Collaborators
OPKO Health, Inc.
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT02119819    
Other Study ID Numbers: 15062
2013-003552-21 ( EudraCT Number )
I7I-MC-XNAA ( Other Identifier: Eli Lilly and Company )
First Posted: April 22, 2014    Key Record Dates
Results First Posted: April 14, 2021
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Keywords provided by OPKO Health, Inc.:
Weight loss
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists