We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucose Variability With DPP-4 Inhibition

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Research Clinical Centre of the Russian Railways, JSC.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751321
First Posted: December 17, 2012
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Research Clinical Centre of the Russian Railways, JSC
  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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Glucose Variability With DPP-4 Inhibition

Resource links provided by NLM:


Further study details as provided by Research Clinical Centre of the Russian Railways, JSC:

Primary Outcome Measures:
  • glucose variability [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751321


Sponsors and Collaborators
Research Clinical Centre of the Russian Railways, JSC
Investigators
Principal Investigator: Alexander Ametov, MD Research Clinical Centre of the Russian Railways, JSC
  More Information

Responsible Party: Research Clinical Centre of the Russian Railways, JSC
ClinicalTrials.gov Identifier: NCT01751321     History of Changes
Other Study ID Numbers: 40591
First Submitted: December 13, 2012
First Posted: December 17, 2012
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action