Clinical trial NCT04314622: A Study of Supaglutide in Chinese Type 2 Diabetes Patients
Official title: A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
First posted: 2020-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
2. 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)
3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m\^2).

Exclusion Criteria:

1. Type 1 diabetes (T1D).
2. Evidences of fasting C-peptide levels\<0.81 ng/mL.
3. History of trauma, infection or surgery within a month;
4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
6. Evidence of abnormal thyroid function within 6 months before screening.
7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
8. History of serious mental illness.
9. History of drug or alcohol abuse.
10. History of a transplanted organ, acquired or congenital immune system diseases.
11. Allergy to active ingredients or excipients of the test drug.
12. Evidence of abnormal result of laboratory examination according to the judgment of researchers.
13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
14. Previously completed or withdrawn from this study after providing informed consent.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 7 weeks, 17weeks
measure: Adverse Events
timeFrame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
measure: Vital Sign
timeFrame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
measure: Laboratory Tests
timeFrame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
measure: 12-lead ECGs
timeFrame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
measure: Immunogenicity Tests
timeFrame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Secondary outcomes:
measure: HbA1c <7%
timeFrame: Baseline, 7 weeks, 17weeks
measure: Glycosylated Albumin
timeFrame: Baseline, 7 weeks, 17weeks
measure: Fasting Blood Glucose
timeFrame: Baseline, 7 weeks, 17weeks
measure: Fasting Blood Insulin
timeFrame: Baseline, 7 weeks, 17weeks
measure: Fasting Blood C-peptide
timeFrame: Baseline, 7 weeks, 17weeks
measure: Blood Lipid
timeFrame: Baseline, 7 weeks, 17weeks
measure: Body Weight
timeFrame: Baseline, 7 weeks, 17weeks
measure: Pharmacokinetics (PK): Area Under the Curve
timeFrame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
measure: Pharmacokinetics (PK): t½ of Supaglutide
timeFrame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
measure: PK: Tmax of Supaglutide
timeFrame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Zhongda Hospital of Southeast University
state: Jiangsu
Study officials:
affiliation: Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
name: Weiping Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
name: Yuqian Bao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: