Glucose Variability With DPP-4 Inhibition

Type 2 Diabetes Clinical Trial

Official title:

Glucose Variability With DPP-4 Inhibition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01751321
• Other study ID #: 40591
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2012
• Last updated: December 13, 2012
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: December 2012
• Source: Research Clinical Centre of the Russian Railways, JSC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

Glucose Variability With DPP-4 Inhibition

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin, placebo
sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Clinical Centre of the Russian Railways, JSC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose variability		1 month	No