Trial record 12 of 92 for:    Open Studies | "Prediabetic State"

Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

This study is currently recruiting participants.
Verified October 2013 by Shandong Provincial Hospital
Chinese Medical Association
Information provided by (Responsible Party):
Xinli Zhou,MD,PHD, Shandong Provincial Hospital Identifier:
First received: October 7, 2013
Last updated: October 9, 2013
Last verified: October 2013

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 .

Condition Intervention Phase
Drug: Saxagliptin
Drug: saxagliptin
Drug: metformin
Other: lifestyle intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity

Resource links provided by NLM:

Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • oral glucose tolerance test [ Time Frame: Change of Blood sugar from baseline at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Onglyza
Active Comparator: Lifestyle intervention
Lifestyle intervention for 6 months
Other: lifestyle intervention
lifestyle intervention for 6 months
Other Name: 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 Name: 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 Name: Onglyza

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.


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01960205

Contact: Xinli Zhou, MD,PhD 15168889976

China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Xinli Zhou, MD, PhD    15168889976   
Principal Investigator: Xinli Zhou, MD,PhD         
Sponsors and Collaborators
Shandong Provincial Hospital
Chinese Medical Association
Principal Investigator: Xinli Zhou, MD, PhD Shandong Provincial Hospital
  More Information

No publications provided

Responsible Party: Xinli Zhou,MD,PHD, Xinli Zhou, Shandong Provincial Hospital Identifier: NCT01960205     History of Changes
Other Study ID Numbers: ZXL-201308
Study First Received: October 7, 2013
Last Updated: October 9, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shandong Provincial Hospital:
Saxagliptin, prediabetes, glucose intolerance,obesity

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014