A Study of Supaglutide in Chinese Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314622
• Other study ID #: YN011B
• Status: Completed
• Phase: Phase 2
• Start date: April 14, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: September 2021
• Source: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 16, 2021
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Supaglutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	The Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.	Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, 7 weeks, 17weeks
Primary	Adverse Events	Number of Adverse Events	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Primary	Vital Sign	Assessments of Vital Sign	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Primary	Laboratory Tests	Assessments of Laboratory Tests	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Primary	12-lead ECGs	Assessments of 12-lead ECGs	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Primary	Immunogenicity Tests	Assessments of Immunogenicity Tests	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Secondary	HbA1c <7%	Percentage of Participants Achieving HbA1c Target <7.0%	Baseline, 7 weeks, 17weeks
Secondary	Glycosylated Albumin	Changes from Baseline in Glycosylated Albumin	Baseline, 7 weeks, 17weeks
Secondary	Fasting Blood Glucose	Changes from Baseline in Fasting Blood Glucose	Baseline, 7 weeks, 17weeks
Secondary	Fasting Blood Insulin	Changes from Baseline in Fasting Blood Insulin	Baseline, 7 weeks, 17weeks
Secondary	Fasting Blood C-peptide	Changes from Baseline in Fasting Blood C-peptide	Baseline, 7 weeks, 17weeks
Secondary	Blood Lipid	Changes from Baseline in Blood Lipid	Baseline, 7 weeks, 17weeks
Secondary	Body Weight	Changes from Baseline in Body Weight	Baseline, 7 weeks, 17weeks
Secondary	Pharmacokinetics (PK): Area Under the Curve	Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-8)	Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Secondary	Pharmacokinetics (PK): t½ of Supaglutide	Terminal Elimination Half-life in Plasma (t½)	Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Secondary	PK: Tmax of Supaglutide	Time to Maximum Plasma Concentration (Tmax)	Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)