GLP-1 Peptide Atlas, by Delfa

UnknownPhase 4

A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese

A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese

Lead sponsor

The First Hospital of Jilin University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 24-40•HbA1c 8-14%

Primary endpoints

•Inducing Diabetes Remission•Maintaining Diabetes Remission•Time of Maintaining Diabetes Remission

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 IDNCT03018665

Org study IDJLUEND001

Timeline

Milestones

Study first posted2017-01-12estimated

Last update posted2017-01-12estimated

Study start2017-02 (month precision)

Primary completion2021-12estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•A signed and dated informed consent form obtained from the subject before any study related procedures take place.

•Age ≥18 years to ≤65 years at Visit 1.

•The subject has a new diagnosis of type 2 diabetes without any treatment.

•HbA1c ≥8.0% to ≤14.0% at Visit 1.

•BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.

Exclusion criteria

•The subject has a history of type 1 diabetes or a secondary form of diabetes.

•The subject has received an anti-diabetic drug before the screening visit.

•Treatment with systemic steroids 2 months prior to screening

•Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.

•The subject has a history of acute or chronic pancreatitis

•Any gastrointestinal diseases or surgeries that induce chronic malabsorption

•Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).

•The subject has a history of recurrent severe hypoglycaemia.

•Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.

•Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).

•Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.

•Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.

•Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.

•Known or suspected abuse of alcohol,narcotics or illicit drugs.

Endpoints (13)

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

Weight & body composition

Cardiometabolic biomarkers

Renal / kidney

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change of Weight

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change of Waistline

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Rate of Inducing Diabetes Remission

Time frame:At the end of 12-week treatment

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Change of Rate of Maintaining Diabetes Remission

Time frame:3,6,12,24,36 months after 12-week treatment

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Time of Maintaining Diabetes Remission

Time frame:up to 36 months after 12-week treatment

time to event, improvement

Secondary/protocol endpoint

Change of Glycosylated Hemoglobin

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change of Pancreatic Beta-cell Function

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

change from baseline, improvement

Secondary/protocol endpoint

Change of Insulin Resistance Index

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

The Incidence of Diabetic Nephropathy

Time frame:up to 36 months after 12-week treatment

time to event, event

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change of Blood Pressure

Time frame:Baseline and 0,3,6,12,24,36 months after 12-week treatment

change from baseline, improvement

Secondary/protocol endpoint

Change of Heart Rate

Time frame:baseline and 0,3,6,12,24,36 months after 12-week treatment

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

The Incidence of Hypoglycemia

Time frame:During the 12-week treatment

Documented hypoglycemia

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

The Incidence of Diabetic Retinopathy

Time frame:up to 36 months after 12-week treatment

time to event, event

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.