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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Glyburide; Insulin; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human; Metformin; Sitagliptin Phosphate

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.