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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 because the information has not been verified recently.
Verified August 2012 by Niigata Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nagaoka Red Cross Hospital
Information provided by (Responsible Party):
Nobumasa Ohara, Niigata Medical Center
ClinicalTrials.gov Identifier:
NCT01642108
First received: June 7, 2012
Last updated: August 19, 2012
Last verified: August 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Niigata Medical Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: One month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Glucagon secretion [ Time Frame: One month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nobumasa Ohara, Principal Investigator, Niigata Medical Center
ClinicalTrials.gov Identifier: NCT01642108     History of Changes
Other Study ID Numbers: 1-Ohara
Study First Received: June 7, 2012
Last Updated: August 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 25, 2014