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Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01642108

Last Updated: 2012-08-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin resistance. Studies have shown that most of the populations in which insulin resistance is considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a predominant role in the non-obese subtype of T2DM which includes majority of Japanese patients.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1) and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose concentrations through increases in glucose dependent insulin release and suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal showed that sitagliptin improved glucose control with decreased glucagon levels and increased insulin concentration in obese or overweight T2DM patients with BMI \> 25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in non-obese patients with low insulin secretion are not known. Therefore, the investigators will examine the effect of sitagliptin on glycemic control and the mechanism involved using a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are \< 25 kg/m2.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin

Group Type OTHER

Sitagliptin

Intervention Type DRUG

50 mg once per day

Interventions

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Sitagliptin

50 mg once per day

Intervention Type DRUG

Other Intervention Names

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Other name is known

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetic patients
* non-obese patients

Exclusion Criteria

* patients treated with insulin therapy
* patients aged less than 20 years and more than 90 years
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nagaoka Red Cross Hospital

OTHER

Sponsor Role collaborator

Niigata Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nobumasa Ohara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nobumasa Ohara

Niigata, Niigata, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Nobumasa Ohara, Medical Doctor

Role: primary

Other Identifiers

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1-Ohara

Identifier Type: -

Identifier Source: org_study_id