Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
NCT ID: NCT04466904
Last Updated: 2021-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2020-09-12
2021-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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IBI362 low dose cohort
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
IBI362
Administrated by subcutaneous injection
Placebo
Administrated by subcutaneous injection
Dulaglutide
Administrated by subcutaneous injection
IBI362 medium dose cohort
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362
Administrated by subcutaneous injection
Placebo
Administrated by subcutaneous injection
Dulaglutide
Administrated by subcutaneous injection
IBI362 high dose cohort
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362
Administrated by subcutaneous injection
Placebo
Administrated by subcutaneous injection
Dulaglutide
Administrated by subcutaneous injection
Interventions
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IBI362
Administrated by subcutaneous injection
Placebo
Administrated by subcutaneous injection
Dulaglutide
Administrated by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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China Japan Friendship Hospital
Beijing, , China
Countries
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References
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Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x.
Other Identifiers
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CIBI362A101
Identifier Type: -
Identifier Source: org_study_id
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