UnknownPhase 4

Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients

Lead sponsor

Dasman Diabetes Institute

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

315

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18-45•HbA1c ≥7%

Primary endpoint

•HbA1c, change

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 IDNCT04135287

Org study IDRA HM-2019-004

Timeline

Milestones

Study first posted2019-10-22actual

Study start2020-03-01actual

Last update posted2020-07-21actual

Primary completion2023-03-01estimated

Study completion2023-07-15estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age21 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

1. age 21-75 years

2. BMI=18-45 kg/m2

3. HbA1c >7.% and <14.0%

4. Subjects must be on stable antihyperglycemic therapy during the 3 months prior to enrolment.

5. Good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, lipid profile.

6. Stable body weight (± 3 lbs) over the preceding three months

7. Not participate in an excessively heavy exercise program.

Exclusion criteria

1. Subjects receiving therapy with GLP-1 RA or received in the past 3 months. Subjects who received GLP-1 therapy > 3 months prior to the study are eligible to participate if their body weight has returned to the pretreatment level.

2. Subjects receiving DPP4 inhibitors or who received DPP4 inhibitor in the 3 month preceding the study. Subjects on DPP4 inhibitors who are interested in switching therapy to GLP-1 RA must have 3 months washout period.

3. Haematocrit < 32.0

4. history of thyroid cancer or pancreatitis,

5. Creatinine > 1.5 mg/dl,

6. history of malignant disease,

7. Pregnancy.

8. Congestive heart failure

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight loss

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

HbA1c

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Beta cell function

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Fasting Plasma Glucagon

Time frame:6 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.