Phase 3
Completed N=506
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01289119 ↗Enrolled (actual)
506
Serious AEs
1.6%
Results posted
Mar 2013
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) — -0.42; -0.99; -0.22; -0.91 percentage glycosylated hemoglobin — p=<0.001
Summary
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.42; -0.99; -0.22; -0.91; -0.25; -0.76 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c Over Time |
-0.24; -0.56; -0.15; -0.43; -0.09; -0.44 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Over Time |
-0.331; -0.719; -0.251; -0.985; 0.284; -0.985 | — |
| SECONDARY Percentage of Participants With Marked Hyperglycemia |
16.9; 4.5; 25.8; 13.4; 23.8; 8.3 | — |
| SECONDARY Change From Baseline in Body Weight |
-1.04; -0.71; -0.82; -0.43; -0.74; -0.15 | — |
| SECONDARY Percentage of Participants With HbA1c ≤6.5% at Week 16 |
12.2; 36.7; 4.1; 21.4; 9.5; 30.0 | — |
| SECONDARY Percentage of Participants With HbA1c ≤7.0% at Week 16 |
30.0; 63.3; 25.8; 55.1; 31.7; 61.7 | — |
| SECONDARY Percentage of Participants With HbA1c ≤7.5% at Week 16 |
53.3; 81.1; 50.5; 80.6; 47.6; 85.0 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c ≥ 0.5% |
41.1; 84.4; 37.1; 70.4; 42.9; 76.7 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c ≥1.0% |
20.0; 50.0; 9.3; 45.9; 19.0; 46.7 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c ≥1.5% |
7.8; 23.3; 1.0; 22.4; 7.9; 8.3 | — |
| SECONDARY Percentage of Participants With a Decrease in HbA1c ≥2.0% |
2.2; 8.9; 0.0; 9.2; 1.6; 3.3 | — |
Eligibility Criteria
Inclusion Criteria
- Has a historical diagnosis of Type 2 Diabetes Mellitus.
- Has a body mass index between acceptable range.
- Is experiencing inadequate glycemic control.
- Body weight keeps constant.
- Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
Exclusion Criteria
- Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
- Has a systolic blood pressure beyond the acceptable range at Screening visit.
- Has New York Heart Association Class III or IV heart failure regardless of therapy.
- Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
- Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
Data sourced from ClinicalTrials.gov (NCT01289119). 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.