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

Sponsor
Eli Lilly and Company
Study ID
NCT01648582
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Insulin glargine — DRUG
    Administered SC per dosing titration schedule
  • Metformin — DRUG
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
  • Sulfonylureas — DRUG
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

Study Details

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 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2019
Primary completion
Aug 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
774 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 for up to 52 weeks. Participants are blinded to the dulaglutide dose.
  • 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 for up to 52 weeks. Participants are blinded to the dulaglutide dose.
  • Active Comparator: Insulin Glargine
    Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.

Primary Outcome Measure

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ]

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