A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT05691712
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus
  • Diabetes Type 2
  • Endocrine System Diseases
  • Glucose Metabolism Disorders
  • Metabolic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.

Key Dates

Start date
Feb 5, 2023
Status verified
Jul 2025
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024

Study Design

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

Arms

  • Experimental: 5 Milligram (mg) Tirzepatide
    Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
  • Experimental: 10 mg Tirzepatide
    Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
  • Experimental: 15 mg Tirzepatide
    Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
  • Placebo Comparator: Placebo
    Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Primary Outcome Measure

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) [ Time Frame: Baseline, Week 40 ]

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