T2DMRS

UnknownPhase 4

Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study

Lead sponsor

xiaolong zhao

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

100

estimated

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥3

Primary endpoints

•Glycaemic remission•Remission rate of type 2 diabetes at a year

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 IDNCT02129985

Org study IDHS2014-005

Timeline

Milestones

Study first posted2014-05-02estimated

Last update posted2014-05-02estimated

Study start2014-02 (month precision)

Primary completion2015-06estimated (month precision)

Study completion2015-09estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•newly diagnosed type 2 diabetes without drug treatment

•25-70 years old age

•Fasting glucose between 7.0-16.7mmol / L

•BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)

•females who have no plan of pregnancy during the study

Exclusion criteria

•acute or chronic complications of diabetes

•myocardial infarction or cerebrovascular events within three months

•serious gastrointestinal diseases

•other serious concomitant diseases

•liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L

•GAD antibodies positive

•history of pancreatitis or pancreatic cancer;

•pregnant or breastfeeding women.

•severe hypertension (blood pressure> 180/110mmhg)

•using corticosteroids, immunosuppressants and cytotoxic therapy.

Endpoints (6)

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

5 endpoints

Primary/protocol endpoint

time to glycaemic remission

Time frame:up to 1 year

time to event, improvement

Primary/protocol endpoint

remission rate of type 2 diabetes at a year.

Time frame:up to 1 year

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

the beta cell function change

Time frame:1 year

change from baseline, improvement

Other/protocol endpoint

HbA1C level at every 3 months during the whole study

Time frame:1 year

descriptive, improvement

LOINC 4548-4

Other/protocol endpoint

mean glucose level during the follow without drug intervention

Time frame:1 year

descriptive

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

number of hypoglycemia and severe hypoglycemia during the study

Time frame:up to 1 year

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

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.