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

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: NPH insulin; Drug: sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02607410

MERS2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

sitagliptin

Active Comparator group

Description:

100mg every day of sitagliptin in patients that were previosly using metformin and glyburide

Treatment:

Drug: sitagliptin

NPH insulin

Active Comparator group

Description:

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

Treatment:

Drug: NPH insulin