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Trial record 2 of 2 for:    LY2944876

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
Last Update Posted : January 29, 2016
Sponsor:
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

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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
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)

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


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Locations
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United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Valley Endocrine, Fresno
Fresno, California, United States, 93720
National Research Institute
Los Angeles, California, United States, 90057
Desert Medical Group Inc
Palm Springs, California, United States, 92262
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States, 33316
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Compass Research
Oviedo, Florida, United States, 32765
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
East West Medical Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Iowa
Iderc, P.L.C.
Des Moines, Iowa, United States, 50314
United States, Kansas
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States, 66606
United States, Missouri
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
St John's Mercy Medical Center
St Louis, Missouri, United States, 63141
Mercy Health Research
Washington, Missouri, United States, 63090
United States, New Hampshire
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States, 03063
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
United States, North Dakota
Lillestol Research LLC
Fargo, North Dakota, United States, 58103
United States, Oregon
The Corvallis Clinic P.C.
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Blair Medical Associates, Inc.
Altoona, Pennsylvania, United States, 16602
United States, Texas
Texas Diabetes and Endocrinology
Austin, Texas, United States, 78731
Dallas Diabetes Endocrine Center
Dallas, Texas, United States, 75230
San Gabriel Clinical Research
Georgetown, Texas, United States, 78626
Oakwell Clinical Research
San Antonio, Texas, United States, 78218
Southwest Health Associates, P.A.
Sugar Land, Texas, United States, 77478
United States, Utah
Wade Family Medicine
Bountiful, Utah, United States, 84010
Greece
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, 11527
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.
Athens, Greece, 11527
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.
Thessaloniki, Greece, 57010
Mexico
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.
Chihuahua, Mexico, 31238
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.
Guadalajara, Mexico, 44690
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.
Tampico, Mexico, 89000
Poland
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.
Bialystok, Poland, 15-351
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.
Gdansk, Poland, 80-546
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.
Gdynia, Poland, 81-553
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.
Lodz, Poland, 90-242
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.
Poznan, Poland, 61-853
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.
Szczecin, Poland, 70-506
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.
Warsaw, Poland, 01-518
Puerto Rico
Manati Medical Center
Manati, Puerto Rico, 00674
American Telemedicine Center
San Juan, Puerto Rico, 00917-3104
Romania
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.
Cluj-Napoca, Romania, 400349
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.
Lasi, Romania, 700547
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.
Ploiesti, Romania, 100342
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.
Targu Mures, Romania, 540098
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.
Timisoara, Romania, 300456
Sponsors and Collaborators
Eli Lilly and Company
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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02119819     History of Changes
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
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists