Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D

Short and Long Term Effects of a Dypeptidil-peptidase-4 Versus Bedtime NPH Insulin as add-on Therapy in Patients With Type 2 Diabetes

To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin , with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide: effects on beta cell function and on metabolic profile.

Glucose control is fundamental in the treatment of type 2 diabetes (DM2). Studies suggest that drugs that boost levels of glucagon-like peptide (GLP-1) improve glycemic control and have long-term beneficial effect on the function of pancreatic beta cells. Objective: To compare the short and long term effects of sitagliptin (which inhibits the DPP-IV enzyme, increasing the levels of GLP-1) with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide. Effects on beta cell function and on metabolic profile were analyzed. Methods: 40 patients with DM2, HbA1c between 6.6 to 10%, in use of metformin and glibenclamide will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group). Measurements of HbA1c, metabolic and hormonal profile at fasting and post-meal (every 30 minutes for 4 hours) will be evaluated before and after 6 months (short term) and 12 months (long term) of adding sitagliptin or NPH insulin.

Inclusion Criteria

• outpatients with T2D inadequately controlled with metformin plus glyburide
• HbA1c levels between 6.6 and 10%
• body mass index < 35 kg/m2

Exclusion Criteria

• heart failure
• respiratory failure
• uncontrolled hypertension
• impaired hepatic function
• impaired reanl function
• endocrine disorder
• gastrointestinal disorder
• malignancy
• alcohol abuse
• previous use of insulin
• previou use of based incretin therapy
• type 1 diabetes.