A Phase 4 interventional study of Saxagliptin and saxagliptin in Prediabetes, sponsored by Shandong Provincial Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by Shandong Provincial Hospital · Phase 4, Interventional, and Treatment
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 .
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
Drug: Saxagliptin
Lifestyle intervention for 6 months
Other: lifestyle intervention
Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
Drug: metformin
Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months
Drug: saxagliptin
5mg a day for 6 months
Also known as: Onglyza
2.5 mg a day for 6 months
Also known as: Onglyza
500mg three times a day for 6 months
Also known as: melbine
lifestyle intervention for 6 months
Also known as: living way intervention
oral glucose tolerance test
Time frame: Change of Blood sugar from baseline at 6 months
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Shandong Provincial Hospital