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

Sponsor
Eli Lilly and Company
Study ID
NCT01644500
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Glimepiride — DRUG
    Administered orally
  • Placebo as Capsules — DRUG
    Placebo for glimepiride is administered orally as one to three capsules daily.
  • Placebo as SC Injection — DRUG
    Placebo for dulaglutide is administered as one SC injection.

Study Details

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

Key Dates

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

Study Design

Enrollment
737 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 plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
  • Experimental: 0.75 mg Dulaglutide
    0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
  • Active Comparator: Glimepiride
    1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.

Primary Outcome Measure

Change From Baseline in HbA1c at 26 Weeks [ Time Frame: Baseline, 26 Weeks ]

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