NCT02756832

An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,409 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.

Detailed description

The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM. The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC). This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Alogliptin Benzoate	Alogliptin benzoate tablets

Timeline

• Start date: 2016-09-20
• Primary completion: 2018-04-28
• Completion: 2018-04-28
• First posted: 2016-04-29
• Last updated: 2019-07-10
• Results posted: 2019-07-10

Locations

53 sites across 1 country: Russia

Regulatory

• FDA-regulated drug study