Phase 3
Completed N=576
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01318135 ↗Enrolled (actual)
576
Serious AEs
5.3%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants With Adverse Events. — 16; 3; 7; 5 participants
Summary
To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
16; 3; 7; 5; 116; 134 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.53; -0.65; -0.53; -0.59 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.63; -0.72; -0.61; -0.71 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 16). |
-0.66; -0.76; -0.69; -0.78 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 20). |
-0.63; -0.70; -0.67; -0.78 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 24). |
-0.59; -0.70; -0.68; -0.78 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 28). |
-0.62; -0.76; -0.70; -0.84 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 32). |
-0.63; -0.77; -0.67; -0.81 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 36). |
-0.64; -0.77; -0.67; -0.79 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 40). |
-0.66; -0.74; -0.63; -0.74 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 44). |
-0.48; -0.71; -0.47; -0.70 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 48). |
-0.40; -0.61; -0.36; -0.62 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 52). |
-0.33; -0.53; -0.29; -0.53 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Final Visit). |
-0.42; -0.58; -0.44; -0.58 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 8). |
-20.7; -19.6; -22.0; -23.4 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 12). |
-22.0; -18.1; -22.9; -24.2 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 16). |
-22.3; -17.8; -21.8; -26.1 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 20). |
-22.4; -22.3; -23.4; -26.1 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 24). |
-24.0; -25.0; -25.6; -26.3 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 28). |
-19.9; -25.9; -25.8; -28.2 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 32). |
-22.4; -26.1; -23.2; -28.2 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 36). |
-25.5; -26.7; -23.4; -26.0 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 40). |
-21.3; -22.7; -19.8; -23.2 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 44). |
-15.4; -21.9; -16.3; -24.0 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 48). |
-13.6; -16.6; -14.3; -23.3 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 52). |
-13.3; -11.9; -14.0; -16.1 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Final Visit). |
-16.0; -13.0; -16.4; -17.7 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). |
80.2; 80.1; 61.6; 64.0 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24). |
87.4; 77.9; 60.7; 62.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). |
83.8; 83.2; 62.5; 62.7 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). |
84.8; 84.9; 63.5; 63.7 | — |
Eligibility Criteria
Inclusion Criteria
Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
- Was capable of understanding and complying with protocol requirements.
- Signed a written informed consent form prior to the initiation of any study procedure.
Exclusion Criteria
Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).
Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:
- With history or symptoms of lactic acidosis.
Data sourced from ClinicalTrials.gov (NCT01318135). 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.