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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Nobumasa Ohara, Niigata Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642108
First Posted: July 17, 2012
Last Update Posted: August 21, 2012
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.
Collaborator:
Nagaoka Red Cross Hospital
Information provided by (Responsible Party):
Nobumasa Ohara, Niigata Medical Center
  Purpose

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 Intervention
Type 2 Diabetes Drug: Sitagliptin

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Nobumasa Ohara, Niigata Medical Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: One month ]

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

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sitagliptin Drug: Sitagliptin
50 mg once per day
Other Name: Other name is known

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01642108


Locations
Japan
Nobumasa Ohara Recruiting
Niigata, Japan, 951-8510
Contact: Nobumasa Ohara, Medical Doctor       oharan@med.niigata-u.ac.jp   
Sponsors and Collaborators
Niigata Medical Center
Nagaoka Red Cross Hospital
  More Information

Responsible Party: Nobumasa Ohara, Principal Investigator, Niigata Medical Center
ClinicalTrials.gov Identifier: NCT01642108     History of Changes
Other Study ID Numbers: 1-Ohara
First Submitted: June 7, 2012
First Posted: July 17, 2012
Last Update Posted: August 21, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action