Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D
- Registration Number
- NCT02607410
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NPH insulin NPH insulin NPH insulin will be applied bedtime every night in patients that awere previously using metformin and glyburide,The insulin dosage will be adjusted to fasting glycemia between 90 and 100 mg / dL sitagliptin sitagliptin 100mg every day of sitagliptin in patients that were previosly using metformin and glyburide
- Primary Outcome Measures
Name Time Method improvement in HbA1c levels six and twelve months Changes in fasting blood levels of HBA1c (%)
- Secondary Outcome Measures
Name Time Method improvement of beta cell function with a meal test six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test Changes in serum C-peptide levels (ng/mL)
improvement on alpha cell function with a meal test six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test Changes in plasma glucagon levels (pg/mL)
Trial Locations
- Locations (1)
University of Sao Paulo General Hospital
🇧🇷Sao Paulo, Brazil