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Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Primary Purpose

Prediabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Saxagliptin
saxagliptin
metformin
lifestyle intervention
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetes focused on measuring Saxagliptin, prediabetes, glucose intolerance,obesity

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.Newly diagnosed insulin resistance or glucose intolerance .

2.20 to 70 years of age.

3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).

Exclusion Criteria:

  1. Under Diabetes Mellitus treatment.
  2. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
  3. Active heart failure.
  4. Unwilling or unable to sign inform consents.

Sites / Locations

  • Shandong Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Standarddose Saxagliptin

Lifestyle intervention

Metformin

low dose Saxagliptin

Arm Description

Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months

Lifestyle intervention for 6 months

Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months

Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months

Outcomes

Primary Outcome Measures

oral glucose tolerance test

Secondary Outcome Measures

Full Information

First Posted
October 7, 2013
Last Updated
September 23, 2014
Sponsor
Shandong Provincial Hospital
Collaborators
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT01960205
Brief Title
Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Official Title
Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
Collaborators
Chinese Medical Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
Detailed Description
Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period. Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
Saxagliptin, prediabetes, glucose intolerance,obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standarddose Saxagliptin
Arm Type
Experimental
Arm Description
Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
Arm Title
Lifestyle intervention
Arm Type
Active Comparator
Arm Description
Lifestyle intervention for 6 months
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
Arm Title
low dose Saxagliptin
Arm Type
Experimental
Arm Description
Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
5mg a day for 6 months
Intervention Type
Drug
Intervention Name(s)
saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
2.5 mg a day for 6 months
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
melbine
Intervention Description
500mg three times a day for 6 months
Intervention Type
Other
Intervention Name(s)
lifestyle intervention
Other Intervention Name(s)
living way intervention
Intervention Description
lifestyle intervention for 6 months
Primary Outcome Measure Information:
Title
oral glucose tolerance test
Time Frame
Change of Blood sugar from baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Newly diagnosed insulin resistance or glucose intolerance . 2.20 to 70 years of age. 3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male). Exclusion Criteria: Under Diabetes Mellitus treatment. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors . Active heart failure. Unwilling or unable to sign inform consents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinli Zhou, MD,PhD
Phone
15168889976
Email
zhouxinli0301@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinli Zhou, MD, PhD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinli Zhou, MD, PhD
Phone
15168889976
Email
zhouxinli0301@163.com
First Name & Middle Initial & Last Name & Degree
Xinli Zhou, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28575729
Citation
Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.
Results Reference
derived

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Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

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