CompletedPhase 1/2

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

China42 participantsStarted 2020-09-12

Plain-language 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 lifestyle or metformin intervention

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo

Timeframe: From the first dose of study drug to week 19

Trial details

NCT IDNCT04466904

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-28

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