Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Overview[ - collapse ][ - ]
| 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 . |
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| Condition | Prediabetes |
| Intervention | Drug: Saxagliptin Drug: saxagliptin Drug: metformin Other: lifestyle intervention |
| Phase | Phase 4 |
| Sponsor | Shandong Provincial Hospital |
| Responsible Party | Shandong Provincial Hospital |
| ClinicalTrials.gov Identifier | NCT01960205 |
| First Received | October 7, 2013 |
| Last Updated | October 9, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 7, 2013 |
|---|---|
| Last Updated Date | October 9, 2013 |
| Start Date | August 2013 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | oral glucose tolerance test [Time Frame: Change of Blood sugar from baseline at 6 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity |
|---|---|
| Official Title | Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity |
| 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 . |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Prediabetes |
| Intervention | Drug: Saxagliptin 5mg a day for 6 months Other Names: OnglyzaDrug: saxagliptin 2.5 mg a day for 6 months Other Names: OnglyzaDrug: metformin 500mg three times a day for 6 months Other Names: melbineOther: lifestyle intervention lifestyle intervention for 6 months Other Names: living way intervention |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 80 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2014 |
| Eligibility 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. |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Xinli Zhou, MD,PhD 15168889976 zhouxinli0301@163.com |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01960205 |
|---|---|
| Other Study ID Numbers | ZXL-201308 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Shandong Provincial Hospital |
| Study Sponsor | Shandong Provincial Hospital |
| Collaborators | Chinese Medical Association |
| Investigators | Principal Investigator: Xinli Zhou, MD, PhD Shandong Provincial Hospital |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Shandong Provincial Hospital | Jinan, Shandong, China, 250021 Contact: Xinli Zhou, MD, PhD | 15168889976 | zhouxinli0301@163.comPrincipal Investigator: Xinli Zhou, MD,PhD Recruiting |
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