GLP-1 Peptide Atlas, by Delfa

CompletedPhase NAResults posted

Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial

Lead sponsor

Sun Yat-sen University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

416

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≤10

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01147627

Org study IDIIT-201007-WJP

Timeline

Milestones

Study first posted2010-06-22estimated

Last update posted2013-08-21estimated

Results first posted2013-08-21estimated

Study start2010-08 (month precision)

Primary completion2012-08actual (month precision)

Study completion2012-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•newly-diagnosed type 2 diabetic patients, drug naïve

•age 30~70 years

•HbA1c 7.0~10.0%

•BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening

•female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion criteria

•acute or severe chronic diabetic complications

•congestive heart failure (NYHA grade Ⅲ~Ⅳ)

•severe gastrointestinal disease

•severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation

•other severe intercurrent illness

•serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)

•tested positive for glutamic acid decarboxylase antibody

•use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug

•history of pancreatitis

•serum triglyceride ≥ 5.0 mmol/L

•pregnancy

Endpoints (4)

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

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks

Time frame:48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Exenatide	-1.8	—
Premixed Insulin Analog	-1.74	—
Thiazolidinedione	-1.47	—

p<0.05ANCOVA

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles

Time frame:48 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)

Time frame:48 weeks

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and Tolerability in Different Groups

Time frame:48 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 July 1, 2026 snapshot.