A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.

Registration

Registration

NCT04314622

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

40

Start

2020-04-14

Primary completion

2020-10-25

Lead sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:Supaglutide; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• HbA1c [Baseline, 7 weeks, 17weeks]
• Adverse Events [Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B]
• Vital Sign [Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B]
• Laboratory Tests [Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B]
• 12-lead ECGs [Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B]
• Immunogenicity Tests [Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B]