Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR
This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to
compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone
Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.
A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The
active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,
gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.
This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to
compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone
Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.
Target population of clinical trial subjects A total of 38 women with documented Type 2
Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible,
clinical trial subjects which are treated with glucose-lowering medication (except incretin
or sulfonylurea based therapies) and treatment-naive subjects will be included.
Investigational Product, posology and method of administration The active treatment will
include a 50 mg dose of vildagliptin OD twice a day.
Comparator, posology and method of administration As comparator, gliclazide MR will be
administered at a dose of 60 to 120 mg OD once a day.
Treatment duration The study will have an expected total duration of 18 months, 12 months of
active treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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