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Glucose Variability With DPP-4 Inhibition

NCT ID: NCT01751321

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-10-31

Brief Summary

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Glucose Variability With DPP-4 Inhibition

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type OTHER

Sitagliptin, placebo

Intervention Type DRUG

sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day

Interventions

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Sitagliptin, placebo

sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day

Intervention Type DRUG

Other Intervention Names

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Januvia

Eligibility Criteria

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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%
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Clinical Centre of the Russian Railways, JSC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Ametov, MD

Role: PRINCIPAL_INVESTIGATOR

Research Clinical Centre of the Russian Railways, JSC

Other Identifiers

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40591

Identifier Type: -

Identifier Source: org_study_id