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UnknownPhase 4

The Effects of Short-Term Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

The Effects of Short-Term Exenatide Therapy on the Beta-Cell Function and Long-term Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

160

estimated

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-9%

Primary endpoints

Time of glycemic remission and remission rateHbA1c <7.0% achievement

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 IDNCT01270191
Org study IDVGHIRB 201010013MB

Timeline

Milestones

Study first posted2011-01-05estimated
Last update posted2013-06-27estimated
Study start2010-11 (month precision)
Primary completion2014-12estimated (month precision)
Study completion2015-12estimated (month precision)

Assets

Investigational agents

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

1. Newly diagnosed type 2 diabetic patients.

2. Age between 30 and 70 years old.

3. HbA1C between 7 and 9% in OPD patients

4. If HbA1c >9.0% of blood glucose >300 mg/dL, intensive insulin therapy for 10-14 days

Exclusion criteria

1. Previous treated with anti-diabetic medication

2. Pregnant or lactation women.

3. Impaired liver function (ALT > 100 U/L)

4. Impaired renal function (Serum creatinine >2.0 mg/dL)

5. Recently suffered from MI or CVA.

6. Patients are acute intercurrent illness.

7. 2-hour C-peptide level < 2.0 ng/mL.

8. History of severe hypersensitivity to any product components.

9. History or high risk of acute pancreatitis.

10. Now use warfarin.

Endpoints (5)

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.

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint/low confidence

the time of glycemic remission and remission rate

Time frame:at one year

descriptive, improvement

Primary/protocol endpoint

The time of monotherapy failure and monotherapy failure rate

Time frame:5 years

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Secondary/protocol endpoint

Beta-cell function and insulin sensitivity calculated from OGTT.

Time frame:at 6 months

descriptive, improvement

Secondary/protocol endpoint

Comparison of A1C change, the proportion of subjects who reached the treatment target

Time frame:6-12 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Comparison of A1C change, the proportion of subjects who reached the treatment target

Time frame:5 years

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.