N/A
Completed N=1,409
An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
Source: ClinicalTrials.gov NCT02756832 ↗Enrolled (actual)
1,409
Serious AEs
0.4%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 — 8.1; -1.2 percentage of glycosylated hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 |
8.1; -1.2 | — |
| SECONDARY Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics |
-1.4; -1.1; -1.3; -1.1; -1.3; -1.4 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 |
52 | — |
| SECONDARY Change From Baseline in HbA1c Level Over Time |
8.1; -0.8; -0.4 | — |
| SECONDARY Percentage of Participants With Marked Hyperglycemia at Month 3 |
0.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time |
8.7; -1.7; -0.4; -2.1 | — |
| SECONDARY Change From Baseline in Weight Over Time |
90.6; -1.5; -1.1; -2.6 | — |
| SECONDARY Change From Baseline in Postprandial Glycemia Over Time |
10.4; -1.9; -0.5; -2.4 | — |
| SECONDARY Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time |
5.6; -0.5; -0.2; -0.6; 2.2; -0.4 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 |
89.1 | — |
| SECONDARY Percentage of Participants Who Used Healthcare Resources |
0.6; 0.1; 0.6; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants ≥ 18 years of age;
- Has a diagnosis of type 2 diabetes mellitus (T2DM)
- Participants with:
- newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
- inadequate glycemic control on previously prescribed any oral antidiabetic drug.
- VIPIDIA® is prescribed according to the approved label for the Russian Federation.
- The participant's physician decides to prescribe VIPIDIA®:
- as monotherapy or
- as a part of combination therapy.
- 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
- Contraindications of respective approved Russian summary of product characteristics (SmPC);
- 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;
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02756832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.