Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Prediabetes Clinical Trial

Official title:

Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01960205
• Other study ID #: ZXL-201308
• Status: Recruiting
• Phase: Phase 4
• First received: October 7, 2013
• Last updated: September 23, 2014
• Start date: August 2013

Study information

• Verified date: September 2014
• Source: Shandong Provincial Hospital
• Contact: Xinli Zhou, MD,PhD
• Phone: 15168889976
• Email: zhouxinli0301[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Drug:
• Saxagliptin
5mg a day for 6 months
• saxagliptin
2.5 mg a day for 6 months
• metformin
500mg three times a day for 6 months

Other:
• lifestyle intervention
lifestyle intervention for 6 months

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Provincial Hospital	Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral glucose tolerance test		Change of Blood sugar from baseline at 6 months	No