Status:
COMPLETED
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 lifes...
Detailed 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 patien...
Eligibility Criteria
Inclusion
- \* Eligibility Criteria： Inclusion Criiteria:
- Male or female 18 to 75 years of age at the time of consent.
- 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.
- HbA1c 7.5% ≤ 11.0% by local laboratory at screening.
- Body mass index 20 ≤ BMI ≤ 35 kg/m2.
- Exclusion Criteria:
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Ketoacidosis or lactic acidosis within 6 months prior to screening.
- History of severe hypoglycaemic episodes within 6 months prior to screening.
- 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.
- 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.
- The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
Exclusion
Key Trial Info
Start Date :
September 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04466904
Start Date
September 12 2020
End Date
May 28 2021
Last Update
July 23 2021
Active Locations (1)
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1
China Japan Friendship Hospital
Beijing, China