Back to resultsA Study of Supaglutide in Chinese Type 2 Diabetes Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Supaglutide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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- Previously completed or withdrawn from this study after providing informed consent.
Sites / Locations
- The Affiliated Zhongda Hospital of Southeast University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Supaglutide (Part A)
Placebo(Part A)
Supaglutide (Part B)
Placebo (Part B)
Arm Description
Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Outcomes
Primary Outcome Measures
HbA1c
Change from Baseline in Hemoglobin A1c (HbA1c)
Adverse Events
Number of Adverse Events
Vital Sign
Assessments of Vital Sign
Laboratory Tests
Assessments of Laboratory Tests
12-lead ECGs
Assessments of 12-lead ECGs
Immunogenicity Tests
Assessments of Immunogenicity Tests
Secondary Outcome Measures
HbA1c <7%
Percentage of Participants Achieving HbA1c Target <7.0%
Glycosylated Albumin
Changes from Baseline in Glycosylated Albumin
Fasting Blood Glucose
Changes from Baseline in Fasting Blood Glucose
Fasting Blood Insulin
Changes from Baseline in Fasting Blood Insulin
Fasting Blood C-peptide
Changes from Baseline in Fasting Blood C-peptide
Blood Lipid
Changes from Baseline in Blood Lipid
Body Weight
Changes from Baseline in Body Weight
Pharmacokinetics (PK): Area Under the Curve
Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞)
Pharmacokinetics (PK): t½ of Supaglutide
Terminal Elimination Half-life in Plasma (t½)
PK: Tmax of Supaglutide
Time to Maximum Plasma Concentration (Tmax)
Full Information
NCT ID
NCT04314622
First Posted
March 11, 2020
Last Updated
September 16, 2021
Sponsor
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Collaborators
Shanghai 6th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04314622
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
October 25, 2020 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Collaborators
Shanghai 6th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supaglutide (Part A)
Arm Type
Experimental
Arm Description
Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
Arm Title
Placebo(Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Arm Title
Supaglutide (Part B)
Arm Type
Experimental
Arm Description
Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Intervention Type
Drug
Intervention Name(s)
Supaglutide
Other Intervention Name(s)
Diabegone
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
HbA1c
Description
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, 7 weeks, 17weeks
Title
Adverse Events
Description
Number of Adverse Events
Time Frame
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Title
Vital Sign
Description
Assessments of Vital Sign
Time Frame
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Title
Laboratory Tests
Description
Assessments of Laboratory Tests
Time Frame
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Title
12-lead ECGs
Description
Assessments of 12-lead ECGs
Time Frame
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Title
Immunogenicity Tests
Description
Assessments of Immunogenicity Tests
Time Frame
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Secondary Outcome Measure Information:
Title
HbA1c <7%
Description
Percentage of Participants Achieving HbA1c Target <7.0%
Time Frame
Baseline, 7 weeks, 17weeks
Title
Glycosylated Albumin
Description
Changes from Baseline in Glycosylated Albumin
Time Frame
Baseline, 7 weeks, 17weeks
Title
Fasting Blood Glucose
Description
Changes from Baseline in Fasting Blood Glucose
Time Frame
Baseline, 7 weeks, 17weeks
Title
Fasting Blood Insulin
Description
Changes from Baseline in Fasting Blood Insulin
Time Frame
Baseline, 7 weeks, 17weeks
Title
Fasting Blood C-peptide
Description
Changes from Baseline in Fasting Blood C-peptide
Time Frame
Baseline, 7 weeks, 17weeks
Title
Blood Lipid
Description
Changes from Baseline in Blood Lipid
Time Frame
Baseline, 7 weeks, 17weeks
Title
Body Weight
Description
Changes from Baseline in Body Weight
Time Frame
Baseline, 7 weeks, 17weeks
Title
Pharmacokinetics (PK): Area Under the Curve
Description
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)
Title
Pharmacokinetics (PK): t½ of Supaglutide
Description
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)
Title
PK: Tmax of Supaglutide
Description
Time to Maximum Plasma Concentration (Tmax)
Time Frame
Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Jia, Doctor
Organizational Affiliation
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuqian Bao, Doctor
Organizational Affiliation
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Zhongda Hospital of Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Supaglutide in Chinese Type 2 Diabetes Patients
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