Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01648582
First received: July 16, 2012
Last updated: September 29, 2014
Last verified: June 2014

July 16, 2012
September 29, 2014
July 2012
May 2014   (final data collection date for primary outcome measure)
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01648582 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β)- cell function (HOMA2-%B) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus
The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with one or two oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea) in addition to any healthy lifestyle changes recommended by their healthcare providers.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Dulaglutide
    Administered SC
    Other Name: LY2189265
  • Drug: Insulin glargine
    Administered SC per dosing titration schedule
  • Drug: Metformin
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: Sulfonylureas
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
  • Experimental: 1.5 mg Dulaglutide
    1.5 milligrams (mg) Dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea. Participants are blinded to the Dulaglutide dose.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Metformin
    • Drug: Sulfonylureas
  • Experimental: 0.75 mg Dulaglutide
    0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea. Participants are blinded to the Dulaglutide dose.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Metformin
    • Drug: Sulfonylureas
  • Active Comparator: Insulin Glargine
    Insulin Glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
    Interventions:
    • Drug: Insulin glargine
    • Drug: Metformin
    • Drug: Sulfonylureas
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
789
November 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have type 2 diabetes mellitus for at least 6 months
  • Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
  • HbA1c value of ≥7.0% to ≤11.0%
  • Adult men or adult non-pregnant, non-breastfeeding women
  • Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)
  • Stable weight (±5%) ≥3 months prior to screening

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
  • Have treatment with dipeptidylpeptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
  • Have gastric emptying abnormality
  • Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
  • Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)
  • Impaired liver function
  • Impaired kidney function
  • Have history of chronic pancreatitis or acute pancreatitis
  • Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
  • Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Mexico,   Russian Federation
 
NCT01648582
13439, H9X-CR-GBDK
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP