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OpenTrials
Completed

NCT Number: NCT02119819

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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., Ampelokipoi, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY2944876

Drug

Administered SC

Exenatide extended-release

Drug

Administered SC

Placebo

Drug

Administered SC

metformin

Drug

Oral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2014
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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