Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability

Summary

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.

Timeline

Start

2012-12

Primary completion

2015-10

Completion

2015-10

Outcome

Missed primary endpoint

paper there was no statistically significant difference between the effect of vildagliptin and gliclazide MR on these variables. PMID 28515791 ↗

paper 0.001 ± 0.153 ng/mL in the vildagliptin group versus 0.008 ± 0.060 ng/mL in the gliclazide MR group (p = 0.858). PMID 28515791 ↗

Publications

• Vianna AGD, de Lacerda CS, Pechmann LM, Polesel MG, Marino EC, Borba VZC, Barreto FC. Vildagliptin has the same safety profile as a sulfonylurea on bone metabolism and bone mineral density in post-menopausal women with type 2 diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2017 May 15;9:35. doi: 10.1186/s13098-017-0232-2. eCollection 2017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Gliclazide	Small molecule	60 mg	Oral
Comparator	Gliclazide	Small molecule	120 mg	Oral
Subject	Vildagliptin	Other / unclassified	50 mg	Oral

Indications