Glucose Variability With DPP-4 Inhibition

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sitagliptin, placebo

• Registration Number: NCT01751321
• Lead Sponsor: Research Clinical Centre of the Russian Railways, JSC

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.

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Last Update Submitted: 2012-12-13
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Study Start: 2013-05
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sitagliptin, metformin, placebo	Sitagliptin, 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

Primary Outcome Measures

Name	Time	Method
glucose variability	1 month