Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Sitagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Nobumasa OharaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sitagliptin
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Glucagon secretion
Full Information
NCT ID
NCT01642108
First Posted
June 7, 2012
Last Updated
August 19, 2012
Sponsor
Niigata Medical Center
Collaborators
Nagaoka Red Cross Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01642108
Brief Title
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Niigata Medical Center
Collaborators
Nagaoka Red Cross Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Other name is known
Intervention Description
50 mg once per day
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
One month
Secondary Outcome Measure Information:
Title
Glucagon secretion
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Nobumasa Ohara
City
Niigata
ZIP/Postal Code
951-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobumasa Ohara, Medical Doctor
Email
oharan@med.niigata-u.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
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