Glucose Variability With DPP-4 Inhibition

Research Clinical Centre of the Russian Railways, JSC0 sites50 target enrollmentMay 2013

ConditionsType 2 Diabetes

InterventionsSitagliptin, placebo

DrugsSitagliptin, placebo

Overview

Phase: Not Applicable
Intervention: Sitagliptin, placebo
Conditions: Type 2 Diabetes
Sponsor: Research Clinical Centre of the Russian Railways, JSC
Enrollment: 50
Primary Endpoint: glucose variability
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Glucose Variability With DPP-4 Inhibition

Detailed Description

Patients with Type 2 Diabetes, age 35-75y., will be included in this double blind randomized placebo controlled study. The sample size of 50 patients completing the 30 day study period is based on statistical input from Merck Research Laboratories, Rahway NJ.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

October 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Research Clinical Centre of the Russian Railways, JSC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes
•receiving a stable dose of metformin ≥ 1500 mg
•HbA1c 7,5% -10/0 %

Exclusion Criteria

•Type 1 diabetes
•HbA1c \< 7,5% and \> 10,0%

Arms & Interventions

sitagliptin, metformin, placebo

1. group- 25 patients will take sitagliptin 50 mg and metformin 1000 mg twice in a day 2. group- 25 patients will take placebo 50 mg and metformin 1000 mg twice in a day

Intervention: Sitagliptin, placebo