NCT01960205

Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DRUG	Saxagliptin	5mg a day for 6 months
DRUG	saxagliptin	2.5 mg a day for 6 months
DRUG	metformin	500mg three times a day for 6 months
OTHER	lifestyle intervention	lifestyle intervention for 6 months

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• First posted: 2013-10-10
• Last updated: 2014-09-25

Locations

1 site across 1 country: China