Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized Double-blind Study to Evaluate the Effect of Linagliptin on Pancreatic Beta Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied.
This is a prospective study of 30 patients with type 2 diabetes mellitus (T2DM) . Patients
with T2DM in the age group 30-65 years and duration of diabetes less than five years will be
screened. After exclusion, those who meet the inclusion criteria will be included in the
study.
Once eligibility criteria are confirmed, patients will be educated about their disease and
will be advised weight maintenance diabetic diet and exercise throughout the study period.
Patients will be randomized to three groups - linagliptin (5mg OD) or voglibose (0.2mg TDS)
or placebo OD. Metformin will be continued in all patients. To evaluate the effect of
linagliptin on insulin sensitivity and beta cell function, independent of changes in HbA1c,
the voglibose group is included. Each group will have 10 patients and will be followed up
for 6 months. Both patients and physicians will be blinded to the treatment.
After having written informed consent, a detailed history and a thorough clinical
examination will be done in all subjects including measurement of height, weight, body mass
index and waist circumference. Hemoglobin, liver function tests, renal function tests, lipid
profile, HbA1c, fasting plasma insulin , C-peptide, homeostasis model assessment-insulin
resistance index(HOMA-1R) and homeostasis model assessment-beta cell function index (HOMA-β)
will be done at baseline. A euglycemic hyperinsulinemic clamp study and a mixed meal test
will be performed in all patients (on different days) at baseline and after 6 months of
follow up. Biochemical parameters will be measured again 6 months after therapy. Fasting and
post-prandial blood glucose will be done monthly for 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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