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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02607410

Enrollment

Registered

2015-11-18

Start date

2010-01-31

Completion date

2014-07-31

Last updated

2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes, sitagliptin, NPH insulin, GLP-1

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.

Interventions

DRUGsitagliptin

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

DRUGNPH insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
improvement in HbA1c levels	six and twelve months	Changes in fasting blood levels of HBA1c (%)

Secondary

Measure	Time frame	Description
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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026