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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02119819
First received: April 17, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2944876
Drug: Exenatide extended-release
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in HbA1c at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Lipids [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Fibroblast Growth Factor 21 [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Requiring Rescue Therapy [ Time Frame: Baseline through Therapy Completion (Week 24) ] [ Designated as safety issue: No ]
  • Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 or Polyethylene Glycol [ Time Frame: Baseline through Therapy Completion (Week 24) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876 [ Time Frame: Baseline through Therapy Completion (Week 24) ] [ Designated as safety issue: No ]
  • Change from Baseline in Adiponectin Levels [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Beta-Hydroxy Butyrate Levels [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Glucagon Levels [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Insulin Levels [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 [ Time Frame: Time Frame: Baseline through Therapy Completion (Week 24) ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119819

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 53 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02119819     History of Changes
Other Study ID Numbers: 15062, 2013‐003552‐21, I7I-MC-XNAA
Study First Received: April 17, 2014
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration
Greece: National Organization of Medicines
Mexico: Federal Commission for Protection Against Health Risks
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Agency for Medicines and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Eli Lilly and Company:
Weight loss

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014