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CompletedPhase 2

A Study of Supaglutide in Chinese Type 2 Diabetes Patients

A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.

Asset

Efsubaglutide Alfa

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

40

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-40•HbA1c 7-10%

Primary endpoints

•HbA1c•Adverse Events•Vital Sign

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04314622
Org study IDYN011B

Timeline

Milestones

Study first posted2020-03-19actual
Study start2020-04-14actual
Primary completion2020-10-25actual
Study completion2021-03-16actual
Last update posted2021-09-17actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
7
Glycemic / diabetes
5
Other (unclassified)
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body Weight

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

HbA1c

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Secondary/protocol endpoint

HbA1c <7%

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Secondary/protocol endpoint

Fasting Blood Glucose

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Secondary/protocol endpoint

Fasting Blood Insulin

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Secondary/protocol endpoint

Fasting Blood C-peptide

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Blood Lipid

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Adverse Events

Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

descriptive

Primary/protocol endpoint

Vital Sign

Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

descriptive

Primary/protocol endpoint

Laboratory Tests

Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

descriptive

Primary/protocol endpoint

Immunogenicity Tests

Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Curve

Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): t½ of Supaglutide

Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)

descriptive

Secondary/protocol endpoint

PK: Tmax of Supaglutide

Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)

concentration, descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

12-lead ECGs

Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

descriptive

Secondary/protocol endpoint/low confidence

Glycosylated Albumin

Time frame:Baseline, 7 weeks, 17weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.