A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05628311
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • placebo — OTHER
    placebo administered subcutaneously (SC) once a week.
  • IBI362 — DRUG
    IBI362 administered subcutaneously (SC) once a week.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control. The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c\<8.5% or HbA1c ≥ 8.5% before randomization.

Key Dates

Start date
Jan 6, 2023
Status verified
Aug 2024
Primary completion
Oct 25, 2023
Completion
May 9, 2024

Study Design

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

Arms

  • Experimental: IBI362 4.0 mg
    ①2mg, subcutaneously (SC), once a week\* 4weeks; ②4mg, SC, once a week\* 44weeks.
  • Experimental: IBI362 6.0 mg
    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks； ③6mg, SC, once a week\* 40weeks.
  • Placebo Comparator: placebo
    * placebo, SC, once a week\* 24weeks; * 2mg, SC, once a week\* 4weeks; * 4mg, SC, once a week\* 4weeks； * 6mg, SC, once a week\* 16weeks.

Primary Outcome Measure

HbA1c change from baseline at week 24 [ Time Frame: Baseline, 24 weeks ]

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