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Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Xinli Zhou,MD,PHD, Shandong Provincial Hospital.
Recruitment status was:  Recruiting
Chinese Medical Association
Information provided by (Responsible Party):
Xinli Zhou,MD,PHD, Shandong Provincial Hospital Identifier:
First received: October 7, 2013
Last updated: September 23, 2014
Last verified: September 2014
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
Prediabetes Drug: Saxagliptin Drug: saxagliptin Drug: metformin Other: lifestyle intervention Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Xinli Zhou,MD,PHD, Shandong Provincial Hospital:

Primary Outcome Measures:
  • oral glucose tolerance test [ Time Frame: Change of Blood sugar from baseline at 6 months ]

Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Primary Completion Date: December 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: September 23, 2014

Keywords provided by Xinli Zhou,MD,PHD, Shandong Provincial Hospital:
Saxagliptin, prediabetes, glucose intolerance,obesity

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017