Status:
COMPLETED
Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
Lead Sponsor:
National University of Malaysia
Conditions:
PreDiabetes
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
There are studies that suggest glycemic response to incretin-based therapies differs between Asians and Caucasians, whereby Asians have better response compared to Caucasians. Hence, the therapeutic r...
Detailed Description
A 12-week, open-label, single treatment study using linagliptin is conducted in 28 prediabetes and 22 T2DM subjects who are divided into low and high fasting GLP-1 groups. Prediabetes are recruited fr...
Eligibility Criteria
Inclusion
- Prediabetes diagnosed from OGTT and T2DM subjects
- HbA1c \> 6.5% and \<10%
- Subjects not receiving any glucose-lowering medication or just receiving metformin and/or sulphonylureas and/or alpha-glucosidase inhibitors on stable dose for at least 3 months.
- Subjects who are willing to participate and sign the informed consent form
Exclusion
- Subjects with ketoacidosis or lactic acidosis, overt diabetes, another disease causing secondary glucose intolerance, congestive heart failure (New York Heart Association Class III or IV), myocardial infarction, stroke or ischemic attacks in past 6 months, uncontrolled severe hypertension, active liver conditions such as cirrhosis or hepatitis \[elevation in liver enzymes to higher activities than double the respective normal value\], moderate to severe renal insufficiency, pregnancy, breast-feeding
- Patients receiving insulin, GLP-1 receptor agonists, dipeptidyl peptidase IV inhibitors or glucose-lowering medications other than metformin /sulphonylureas /alpha-glucosidase inhibitors as treatment.
- Subjects with uncontrolled blood glucose HbA1c\>10%
- Subjects who plan to move out of state / country
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05290506
Start Date
August 1 2020
End Date
March 1 2021
Last Update
March 22 2022
Active Locations (1)
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1
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia, 81100