Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Innovent Biologics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Dulaglutide; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT04466904

CIBI362A101

Details and patient eligibility

About

This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention

Full description

This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

* Eligibility Criteria： Inclusion Criiteria:

1. Male or female 18 to 75 years of age at the time of consent.
2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months prior to screening.
3. HbA1c 7.5% ≤ 11.0% by local laboratory at screening.
4. Body mass index 20 ≤ BMI ≤ 35 kg/m2.

Exclusion Criteria:

1. Type 1 diabetes, special types of diabetes, or gestational diabetes.
2. Ketoacidosis or lactic acidosis within 6 months prior to screening.
3. History of severe hypoglycaemic episodes within 6 months prior to screening.
4. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening.
5. Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) > 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening.
6. The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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42 participants in 3 patient groups

IBI362 low dose cohort

Experimental group

Description:

Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.

Treatment:

Drug: Dulaglutide

Drug: Placebo

Drug: IBI362

IBI362 medium dose cohort

Experimental group

Description:

Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Treatment:

Drug: Dulaglutide

Drug: Placebo

Drug: IBI362

IBI362 high dose cohort

Experimental group

Description:

Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Treatment:

Drug: Dulaglutide

Drug: Placebo

Drug: IBI362