Glucose Variability With DPP-4 Inhibition

Research Clinical Centre of the Russian Railways, JSC

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin, placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01751321

40591

Details and patient eligibility

About

Glucose Variability With DPP-4 Inhibition

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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%

Trial design

50 participants in 1 patient group

sitagliptin, metformin, placebo

Other group

Description:

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

Treatment:

Drug: Sitagliptin, placebo