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Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

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ClinicalTrials.gov Identifier: NCT01960205
Recruitment Status : Unknown
Verified September 2014 by Xinli Zhou，MD，PHD, Shandong Provincial Hospital.
Recruitment status was:  Recruiting
First Posted : October 10, 2013
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by (Responsible Party):
Xinli Zhou，MD，PHD, Shandong Provincial Hospital

Study Description
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Brief 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 .

Condition or disease Intervention/treatment Phase
Prediabetes Drug: Saxagliptin Drug: saxagliptin Drug: metformin Other: lifestyle intervention Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
Drug Information available for: Saxagliptin

Arms and Interventions
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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 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


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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960205


Contacts
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Contact: Xinli Zhou, MD,PhD 15168889976 zhouxinli0301@163.com

Locations
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China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Xinli Zhou, MD, PhD    15168889976    zhouxinli0301@163.com   
Principal Investigator: Xinli Zhou, MD,PhD         
Sponsors and Collaborators
Shandong Provincial Hospital
Chinese Medical Association
Investigators
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Principal Investigator: Xinli Zhou, MD, PhD Shandong Provincial Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xinli Zhou，MD，PHD, Xinli Zhou, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT01960205    
Other Study ID Numbers: ZXL-201308
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Xinli Zhou，MD，PHD, Shandong Provincial Hospital:
Saxagliptin, prediabetes, glucose intolerance,obesity
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
 Metformin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action