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

• Status: Completed
• Trial end date: 2018-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin

Criteria

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.