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Glucose Variability With DPP-4 Inhibition

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ClinicalTrials.gov Identifier: NCT01751321
Recruitment Status : Unknown
Verified December 2012 by Research Clinical Centre of the Russian Railways, JSC.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Research Clinical Centre of the Russian Railways, JSC

Brief Summary:
Glucose Variability With DPP-4 Inhibition

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin, placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Glucose Variability With DPP-4 Inhibition
Study Start Date : May 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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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%

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

Responsible Party: Research Clinical Centre of the Russian Railways, JSC
ClinicalTrials.gov Identifier: NCT01751321     History of Changes
Other Study ID Numbers: 40591
First Posted: December 17, 2012    Key Record Dates
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