Trial · NCT01318135
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
NCT01318135, Phase 2, Phase 3, Completed, Takeda; results first posted 2012-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan. Trials, record NCT01318135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01318135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
- NCT number
- NCT01318135
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 576 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Alogliptin and glimepiride, Alogliptin and glimepiride, Alogliptin and metformin, Alogliptin and metformin
- First posted
- 2011-03-18
- Last updated
- 2012-08-16
- Results first posted
- 2012-08-16
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | 52 Weeks. | Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and Week 16. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and Week 20. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 24). | Baseline and Week 24. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 28). | Baseline and Week 28. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 32). | Baseline and Week 32. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 36). | Baseline and Week 36. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 40). | Baseline and Week 40. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events. | 52 Weeks. | Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and Week 16. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and Week 20. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 24). | Baseline and Week 24. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 28). | Baseline and Week 28. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 32). | Baseline and Week 32. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 36). | Baseline and Week 36. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 40). | Baseline and Week 40. | Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events. | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Serious Adverse Event | 16 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Serious Adverse Event | 3 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Serious Adverse Event | 7 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | Serious Adverse Event | 5 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | Other Adverse Event (≥3% Frequency Threshold) | 116 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | Other Adverse Event (≥3% Frequency Threshold) | 134 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | Other Adverse Event (≥3% Frequency Threshold) | 108 | participants | |
| Number of Participants With Adverse Events. | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | Other Adverse Event (≥3% Frequency Threshold) | 113 | participants | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | -0.53 | Standard Deviation 0.506 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | -0.65 | Standard Deviation 0.515 | percentage of Glycosylated Hemoglobin |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled - Long-Term Extension Study | STARTED | CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group | 99 | |
| Enrolled - Long-Term Extension Study | STARTED | CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group | 102 | |
| Enrolled - Long-Term Extension Study | STARTED | Glimepiride Monotherapy Group* → 12.5 mg Combination Group | 46 | |
| Enrolled - Long-Term Extension Study | STARTED | Glimepiride Monotherapy Group* → 25 mg Combination Group | 49 | |
| Enrolled - Long-Term Extension Study | STARTED | CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group | 91 | |
| Enrolled - Long-Term Extension Study | STARTED | CCT/006 - 25 mg Dose Group* → 25 mg Combination Group | 90 | |
| Enrolled - Long-Term Extension Study | STARTED | Metformin Monotherapy Group* → 12.5 mg Combination Group | 50 | |
| Enrolled - Long-Term Extension Study | STARTED | Metformin Monotherapy Group* → 25 mg Combination Group | 49 | |
| Enrolled - Long-Term Extension Study | COMPLETED | CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group | 97 | |
| Enrolled - Long-Term Extension Study | COMPLETED | CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group | 102 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | 0 | 150 | |
| other | Alanine aminotransferase increased | Investigations | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | 0 | 152 | |
| other | Alanine aminotransferase increased | Investigations | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | 6 | 142 | |
| other | Alanine aminotransferase increased | Investigations | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | 2 | 145 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | 6 | 150 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | 4 | 152 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | 2 | 142 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | 6 | 145 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | 8 | 150 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | 11 | 152 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | ||
| Total, all-cause mortality | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | ||
| Total, all-cause mortality | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | ||
| Total, all-cause mortality | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | ||
| Total, other adverse events | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | 116 | 150 |
| Total, other adverse events | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | 134 | 152 |
| Total, other adverse events | Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | 108 | 142 |
| Total, other adverse events | Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | 113 | 145 |
| Total, serious adverse events | Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | 16 | 150 |
| Total, serious adverse events | Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | 3 | 152 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24843617 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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