A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Sponsor
Eli Lilly and Company
Study ID
NCT04093752
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Insulin Glargine — DRUG
    Administered SC

Study Details

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

Key Dates

Start date
Dec 9, 2019
Status verified
Dec 2022
Primary completion
Nov 1, 2021
Completion
Nov 24, 2021

Study Design

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

Arms

  • Experimental: 5 mg Tirzepatide
    Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
  • Experimental: 10 mg Tirzepatide
    Participants received 10 mg tirzepatide administered SC QW.
  • Experimental: 15 mg Tirzepatide
    Participants received 15 mg tirzepatide administered SC QW.
  • Active Comparator: Insulin Glargine
    Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.

Primary Outcome Measure

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]

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