Status:
UNKNOWN
Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients
Lead Sponsor:
Dasman Diabetes Institute
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
GLP-1 receptor agonists (GLP-1 RA) is group of antidiabetic agents very effective in lowering the plasma glucose concentration in T2DM patients . Currently there are several agents approved for the tr...
Detailed Description
Study Design: Eligible subjects will receive the following: (1) medical history and physical examination, (2) Measurement of general chemistry, CBC, HbA1c, TSH, and (3) 75 grams OGTT. After completin...
Eligibility Criteria
Inclusion
- age 21-75 years
- BMI=18-45 kg/m2
- HbA1c \>7.% and \<14.0%
- Subjects must be on stable antihyperglycemic therapy during the 3 months prior to enrolment.
- Good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, lipid profile.
- Stable body weight (± 3 lbs) over the preceding three months
- Not participate in an excessively heavy exercise program.
Exclusion
- 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.
- 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.
- Haematocrit \< 32.0
- history of thyroid cancer or pancreatitis,
- Creatinine \> 1.5 mg/dl,
- history of malignant disease,
- Pregnancy.
- Congestive heart failure
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2023
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04135287
Start Date
March 1 2020
End Date
July 15 2023
Last Update
July 21 2020
Active Locations (1)
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1
Dasman Diabetes Institute
Kuwait City, Kuwait, 15462