A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
IBI362 low dose cohort
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
Intervention: IBI362 (Drug)
IBI362 low dose cohort
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
Intervention: Placebo (Drug)
IBI362 low dose cohort
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
Intervention: Dulaglutide (Drug)
IBI362 medium dose cohort
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: IBI362 (Drug)
IBI362 medium dose cohort
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: Placebo (Drug)
IBI362 medium dose cohort
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: Dulaglutide (Drug)
IBI362 high dose cohort
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: IBI362 (Drug)
IBI362 high dose cohort
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: Placebo (Drug)
IBI362 high dose cohort
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention: Dulaglutide (Drug)
Outcomes
Primary Outcomes
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Time Frame: From the first dose of study drug to week 19
Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
Secondary Outcomes
- The PK/PD parameters of IBI362 in patients with T2DM(From Baseline to week 12)
- Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM(From Baseline to week 12)
- Evaluate the Glucagon of IBI362 in patients with T2DM(From Baseline to week 12)
- Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM(From Baseline to week 12)
- Evaluate the Insulin of IBI362 in patients with T2DM(From Baseline to week 12)
- Number of Participants With Anti-IBI362 Antibodies(From the first dose of study drug to week 19)
- Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM(From Baseline to week 12)
- Evaluate the C-peptide of IBI362 in patients with T2DM(From Baseline to week 12)