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

Takeda

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: Alogliptin Benzoate

Study type: Observational

Funder types: Industry

Identifiers

NCT02756832

MACS-2015-101024 (Other Identifier)

Alogliptin-4018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female participants ≥ 18 years of age;

2. Has a diagnosis of type 2 diabetes mellitus (T2DM)

3. Participants with:

   • newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
   • inadequate glycemic control on previously prescribed any oral antidiabetic drug.

4. VIPIDIA® is prescribed according to the approved label for the Russian Federation.

5. The participant's physician decides to prescribe VIPIDIA®:

   • as monotherapy or
   • as a part of combination therapy.

6. The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.

Exclusion criteria

1. Contraindications of respective approved Russian summary of product characteristics (SmPC);
2. In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;
3. Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.
4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Trial design

1,409 participants in 1 patient group

Alogliptin Benzoate

Description:

Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.

Treatment:

Drug: Alogliptin Benzoate