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

NCT01642108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-08-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sitagliptin

50 mg once per day

Sponsors & Collaborators

  • Nagaoka Red Cross Hospital

    collaborator OTHER

  • Niigata Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642108 on ClinicalTrials.gov