Status:
COMPLETED
A Study of Supaglutide in Chinese Type 2 Diabetes Patients
Lead Sponsor:
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Collaborating Sponsors:
Shanghai 6th People's Hospital
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
- Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
- Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
- Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m\^2).
Exclusion
- Type 1 diabetes (T1D).
- Evidences of fasting C-peptide levels\<0.81 ng/mL.
- History of trauma, infection or surgery within a month;
- History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
- History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
- Evidence of abnormal thyroid function within 6 months before screening.
- Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
- History of serious mental illness.
- History of drug or alcohol abuse.
- History of a transplanted organ, acquired or congenital immune system diseases.
- Allergy to active ingredients or excipients of the test drug.
- Evidence of abnormal result of laboratory examination according to the judgment of researchers.
- Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
- Previously completed or withdrawn from this study after providing informed consent.
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04314622
Start Date
April 14 2020
End Date
March 16 2021
Last Update
September 17 2021
Active Locations (1)
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1
The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China, 210000