Glucose Variability With DPP-4 Inhibition

December 13, 2012 updated by: Research Clinical Centre of the Russian Railways, JSC
Glucose Variability With DPP-4 Inhibition

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Drug: Sitagliptin, placebo
sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose variability
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Clinical Centre of the Russian Railways, JSC

Investigators

  • Principal Investigator: Alexander Ametov, MD, Research Clinical Centre of the Russian Railways, JSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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