Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Shandong First Medical University

Status and phase: Unknown; Phase 4

Conditions: Prediabetes

Treatments: Drug: saxagliptin; Drug: Saxagliptin; Other: lifestyle intervention; Drug: metformin

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01960205

ZXL-201308

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Standarddose Saxagliptin

Experimental group

Description:

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

Treatment:

Drug: Saxagliptin

Lifestyle intervention

Active Comparator group

Description:

Lifestyle intervention for 6 months

Treatment:

Other: lifestyle intervention

Metformin

Active Comparator group

Description:

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

Treatment:

Drug: metformin

low dose Saxagliptin

Experimental group

Description:

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

Treatment:

Drug: saxagliptin