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Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
1
Enrollment
315
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI 18-45•HbA1c ≥7%
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointWeight loss
Time frame:6 months
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
3 endpointsHbA1c
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Beta cell function
Time frame:6 months
change from baseline, improvement
Fasting Plasma Glucagon
Time frame:6 months
change from baseline, improvement
Provenance
Sources
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.