Phase 3
Completed N=3,323
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00306384 ↗Enrolled (actual)
3,323
Serious AEs
16.4%
Results posted
Mar 2013
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 87.2; 87.1; 84.6; 25.6 percentage of participants
Summary
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
87.2; 87.1; 84.6; 25.6; 22.7; 24.9 | — |
| SECONDARY Change From Baseline Over Time in Glycosylated Hemoglobin |
7.21; 7.22; 9.30; 0.18; 0.14; -0.52 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
144.4; 142.6; 215.3; 14.8; 14.9; -26.4 | — |
| SECONDARY Percentage of Participants With Marked Hyperglycemia |
9.1; 8.0; 55.5; 11.5; 10.2; 45.9 | — |
| SECONDARY Change From Baseline in Proinsulin Level |
26.1; 25.4; 40.2; 4.1; 39.7; -3.3 | — |
| SECONDARY Change From Baseline in Insulin Level |
15.19; 15.50; 18.64; 2.45; 2.13; 5.62 | — |
| SECONDARY Change From Baseline in C-peptide Level |
3.406; 3.323; 3.572; -0.471; -0.439; -0.641 | — |
| SECONDARY Change From Baseline in Body Weight |
86.12; 86.61; 88.62; -0.64; -0.61; 0.25 | — |
| SECONDARY Percentage of Participants With a Clinical Response |
34.8; 34.1; 11.0; 64.1; 65.5; 27.1 | — |
Eligibility Criteria
Inclusion Criteria
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase III studies. The study will be open to all patients who completed one of these studies through the end-of-treatment visit:
- SYR-322-PLC-010 - NCT00286455
- SYR-322-SULF-007 - NCT00286468
- SYR-322-MET-008 - NCT00286442
- SYR-322-TZD-009 - NCT00286494
- SYR-322-INS-011 - NCT00286429
- 01-05-TL-322OPI-001 - NCT00328627
- 01-06-TL-322OPI-002 - NCT00395512
- Alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dL.
- Able and willing to monitor own blood glucose concentrations with a home glucose monitor.
- No major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
Exclusion Criteria
- The occurrence of any adverse event or condition during the controlled Phase III studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Weight-loss drugs
- Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and glucagon-like peptide-1 (GLP 1) inhibitors
- Incretin Mimetics,
- Oral or systemically injected glucocorticoids.
Data sourced from ClinicalTrials.gov (NCT00306384). 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.