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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. Identifier: NCT02119819
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Eli Lilly and Company

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 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.

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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

Arm Intervention/treatment
Experimental: Dose 1 LY2944876
Dose 1 of LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
Drug: LY2944876
Administered SC

Experimental: Dose 2 LY2944876
Dose 2 of LY2944876 given SC once weekly for 24 weeks.
Drug: LY2944876
Administered SC

Experimental: Dose 3 LY2944876
Dose 3 of LY2944876 given SC once weekly for 24 weeks.
Drug: LY2944876
Administered SC

Experimental: Dose 4 LY2944876
Dose 4 of LY2944876 given SC once weekly for 24 weeks.
Drug: LY2944876
Administered SC

Experimental: Exenatide extended-release
2 milligrams (mg) exenatide extended-release given SC once weekly for 24 weeks.
Drug: Exenatide extended-release
Administered SC

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.
Drug: Placebo
Administered SC

Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c at Week 24 [ Time Frame: Baseline, Week 24 ]
  2. Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 12, Week 24 ]
  3. Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Week 12, Week 24 ]
  4. Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 12, Week 24 ]
  5. Change from Baseline in Lipids [ Time Frame: Baseline, Week 24 ]
  6. Change from Baseline in Fasting Fibroblast Growth Factor 21 [ Time Frame: Baseline, Week 12, Week 24 ]
  7. Percentage of Participants Requiring Rescue Therapy [ Time Frame: Baseline through Therapy Completion (Week 24) ]
  8. Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 or Polyethylene Glycol [ Time Frame: Baseline through Therapy Completion (Week 24) ]
  9. Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876 [ Time Frame: Baseline through Therapy Completion (Week 24) ]
  10. Change from Baseline in Adiponectin Levels [ Time Frame: Baseline, Week 12, Week 24 ]
  11. Change from Baseline in Beta-Hydroxy Butyrate Levels [ Time Frame: Baseline, Week 12, Week 24 ]
  12. Change from Baseline in Glucagon Levels [ Time Frame: Baseline, Week 12, Week 24 ]
  13. Change from Baseline in Insulin Levels [ Time Frame: Baseline, Week 12, Week 24 ]
  14. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 [ Time Frame: Time Frame: Baseline through Therapy Completion (Week 24) ]

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.

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

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)

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 identifier (NCT number): NCT02119819

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Sponsors and Collaborators
Eli Lilly and Company
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company 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
Last Update Posted: January 29, 2016
Last Verified: December 2015
Keywords provided by Eli Lilly and Company:
Weight loss
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists