Clinical trial NCT04466904: Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Official title: A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 lifestyle or metformin intervention

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 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).

Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: The PK/PD parameters of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the Glucagon of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the Insulin of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Evaluate the C-peptide of IBI362 in patients with T2DM
timeFrame: From Baseline to week 12
measure: Number of Participants With Anti-IBI362 Antibodies
timeFrame: From the first dose of study drug to week 19
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
Study officials:
References:
citation: 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.