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Glucose Variability With DPP-4 Inhibition

This study is not yet open for participant recruitment.
Verified December 2012 by Scientific Clinical Center of OJSC Russian Railways
Sponsor:
Information provided by (Responsible Party):
Scientific Clinical Center of OJSC Russian Railways
ClinicalTrials.gov Identifier:
NCT01751321
First received: December 13, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Glucose Variability With DPP-4 Inhibition


Condition Intervention
Type 2 Diabetes
 Drug: Sitagliptin, placebo

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Glucose Variability With DPP-4 Inhibition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Scientific Clinical Center of OJSC Russian Railways:

Primary Outcome Measures:
  • glucose variability [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned 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
 Drug: Sitagliptin, placebo
sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day
Other Name: Januvia

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751321

Sponsors and Collaborators
Scientific Clinical Center of OJSC Russian Railways
Investigators
Principal Investigator: Alexander Ametov, MD Scientific Clinical Center of OJSC Russian Railways
  More Information

No publications provided

Responsible Party: Scientific Clinical Center of OJSC Russian Railways
ClinicalTrials.gov Identifier: NCT01751321     History of Changes
Other Study ID Numbers: 40591
Study First Received: December 13, 2012
Last Updated: December 13, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013