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Trial record 30 of 39 for:    LY2189265

A Study of LY3298176 in Participants With Type 2 Diabetes Mellitus

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: NCT03131687
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the efficacy of the study drug LY3298176 in participants with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: LY3298176 Drug: Dulaglutide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : March 28, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
Experimental: LY3298176 Dose 1 + Placebo
LY3298176 and placebo given subcutaneously (SC).
Drug: LY3298176
Administered SC

Drug: Placebo
Administered SC

Experimental: LY3298176 Dose 2 + Placebo
LY3298176 and placebo given SC.
Drug: LY3298176
Administered SC

Drug: Placebo
Administered SC

Experimental: LY3298176 Dose 3 + Placebo
LY3298176 and placebo given SC.
Drug: LY3298176
Administered SC

Drug: Placebo
Administered SC

Experimental: LY3298176 Dose 4 + Placebo
LY3298176 and placebo given SC.
Drug: LY3298176
Administered SC

Drug: Placebo
Administered SC

Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC

Active Comparator: Dulaglutide + Placebo
Dulaglutide and placebo given SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
    Change from baseline in body weight

  2. Percentage of Participants with 5% or Greater Body Weight Loss from Baseline [ Time Frame: Week 26 ]
    Percentage of participants with 5% or greater body weight loss from baseline

  3. Change from Baseline in HbA1c [ Time Frame: Baseline, Week 12 ]
    Change from baseline in HbA1c

  4. Percentage of Participants Reaching the HbA1c Target of ≤6.5% and of ≤7.0% [ Time Frame: Week 26 ]
    Percentage of participants reaching the HbA1c target of ≤6.5% and of ≤7.0%

  5. Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in fasting blood glucose

  6. Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HDL-C

  7. Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 26 ]
    Change from baseline in total cholesterol

  8. Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 26 ]
    Change from baseline in triglycerides

  9. Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in LDL-C

  10. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 26 ]
    Change from baseline in waist circumference

  11. Number of Participants with Anti-LY3298176 Antibodies [ Time Frame: Baseline through Week 30 ]
    Number of participants with anti-LY3298176 antibodies

  12. Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of LY3298176 [ Time Frame: Baseline through Week 26 ]
    PK: Model predicted Css of LY3298176



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.
  • Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
  • If on metformin, have been treated with stable doses of metformin for at least 3 months.
  • Have a body mass index (BMI) ≥23 and <50 kilograms per square meter.

Exclusion Criteria:

  • Have type 1 diabetes (T1D).
  • Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.
  • Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
  • Have had chronic or acute pancreatitis any time prior to study entry.
  • Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
  • Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
  • Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.

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): NCT03131687


  Show 49 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03131687     History of Changes
Other Study ID Numbers: 16335
I8F-MC-GPGB ( Other Identifier: Eli Lilly and Company )
2016-004179-33 ( EudraCT Number )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors