NCT04466904

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

July 1, 2020

Last Update Submit

July 21, 2021

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period

    From the first dose of study drug to week 19

Secondary Outcomes (8)

  • 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 Area under the plasma concentration versus time curve (AUC) 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 Glucagon of IBI362 in patients with T2DM

    From Baseline to week 12

  • +3 more secondary outcomes

Study Arms (3)

IBI362 low dose cohort

EXPERIMENTAL

Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.

Drug: IBI362Drug: PlaceboDrug: Dulaglutide

IBI362 medium dose cohort

EXPERIMENTAL

Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Drug: IBI362Drug: PlaceboDrug: Dulaglutide

IBI362 high dose cohort

EXPERIMENTAL

Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Drug: IBI362Drug: PlaceboDrug: Dulaglutide

Interventions

IBI362DRUG

Administrated by subcutaneous injection

IBI362 high dose cohortIBI362 low dose cohortIBI362 medium dose cohort
PlaceboDRUG

Administrated by subcutaneous injection

IBI362 high dose cohortIBI362 low dose cohortIBI362 medium dose cohort
DulaglutideDRUG

Administrated by subcutaneous injection

IBI362 high dose cohortIBI362 low dose cohortIBI362 medium dose cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Japan Friendship Hospital

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 35750681DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mazdutidedulaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 10, 2020

Study Start

September 12, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

CN(1)