Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Inositol; Insulin; Linagliptin; Voglibose

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus (according to ADA guidelines)

• Age between 30-65 years

• Duration of diabetes less than five years

• BMI of between 20 and 40 kg/m2

• HbA1c level of < 7.5%

• On metformin monotherapy for at least 6 weeks

Exclusion Criteria:

• History of ketoacidosis

• Hepatic impairment (defined as plasma aminotransferase elevations of more than 3 times upper limit of normal)

• Renal failure (defined as Serum Creatinine more than 1.5 mg/dl)

• Coronary artery disease or heart failure

• Cerebrovascular disease or stroke

• Anemia (Hb< 10 g/dl)

• Those who requires insulin therapy HbA1c >7.5%

• Presence of macular edema

• Pregnant or lactating women

• Patients who have received dipeptidyl peptidase 4 (DPP-4) inhibitor therapy within last 3 months