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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year
patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil
improvement in HbA1c levels
Changes in fasting blood levels of HBA1c (%)
Time frame: six and twelve months
improvement of beta cell function with a meal test
Changes in serum C-peptide levels (ng/mL)
Time frame: six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test
improvement on alpha cell function with a meal test
Changes in plasma glucagon levels (pg/mL)
Time frame: six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.