Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

September 23, 2014 updated by: Xinli Zhou，MD，PHD, Shandong Provincial Hospital

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Xinli Zhou, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standarddose Saxagliptin
Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
Drug: Saxagliptin
5mg a day for 6 months
Other Names:
  • Onglyza
Active Comparator: Lifestyle intervention
Lifestyle intervention for 6 months
Other: lifestyle intervention
lifestyle intervention for 6 months
Other Names:
  • living way intervention
Active Comparator: Metformin
Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
Drug: metformin
500mg three times a day for 6 months
Other Names:
  • melbine
Experimental: low dose Saxagliptin
Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months
Drug: saxagliptin
2.5 mg a day for 6 months
Other Names:
  • Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oral glucose tolerance test
Time Frame: Change of Blood sugar from baseline at 6 months
Change of Blood sugar from baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Collaborators

Chinese Medical Association

Investigators

  • Principal Investigator: Xinli Zhou, MD, PhD, Shandong Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZXL-201308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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