COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642108
Recruitment Status : Unknown
Verified August 2012 by Nobumasa Ohara, Niigata Medical Center.
Recruitment status was:  Recruiting
First Posted : July 17, 2012
Last Update Posted : August 21, 2012
Nagaoka Red Cross Hospital
Information provided by (Responsible Party):
Nobumasa Ohara, Niigata Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, on Glycemic Control and Inappropriate Glucagon Secretion in Non-obese Japanese Patients With Type 2 Diabetes.
Study Start Date : July 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sitagliptin Drug: Sitagliptin
50 mg once per day
Other Name: Other name is known

Primary Outcome Measures :
  1. HbA1c [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Glucagon secretion [ Time Frame: One month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01642108

Layout table for location information
Nobumasa Ohara Recruiting
Niigata, Japan, 951-8510
Contact: Nobumasa Ohara, Medical Doctor   
Sponsors and Collaborators
Niigata Medical Center
Nagaoka Red Cross Hospital
Layout table for additonal information
Responsible Party: Nobumasa Ohara, Principal Investigator, Niigata Medical Center Identifier: NCT01642108    
Other Study ID Numbers: 1-Ohara
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action