Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Phase 4

• Conditions: Prediabetes
• Interventions: Other: lifestyle intervention; Drug: metformin; Drug: saxagliptin

• Registration Number: NCT01960205
• Lead Sponsor: Shandong Provincial Hospital

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	lifestyle intervention	Lifestyle intervention for 6 months
Metformin	metformin	Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
Standarddose Saxagliptin	saxagliptin	Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
low dose Saxagliptin	saxagliptin	Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months

Primary Outcome Measures

Name	Time	Method
oral glucose tolerance test	Change of Blood sugar from baseline at 6 months

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China