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Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Shandong Provincial Hospital
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by (Responsible Party):
Xinli Zhou,MD,PHD, Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01960205
First received: October 7, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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: 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: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01960205

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

Locations
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
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
ClinicalTrials.gov Identifier: NCT01960205     History of Changes
Other Study ID Numbers: ZXL-201308
Study First Received: October 7, 2013
Last Updated: September 23, 2014
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Metformin
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014