The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210000, China
NCT Number: NCT04314622
A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, 210000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Other names: Diabegone
Administered SC
Time frame: Baseline, 7 weeks, 17weeks
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Number of Adverse Events
Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Vital Sign
Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Laboratory Tests
Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of 12-lead ECGs
Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Immunogenicity Tests
Time frame: Baseline, 7 weeks, 17weeks
Percentage of Participants Achieving HbA1c Target <7.0%
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Glycosylated Albumin
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood Glucose
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood Insulin
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood C-peptide
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Blood Lipid
Time frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Body Weight
Time frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞)
Time frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Terminal Elimination Half-life in Plasma (t½)
Time frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
Time to Maximum Plasma Concentration (Tmax)
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Other
A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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