Trial · NCT01263470
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
NCT01263470, Phase 2, Completed, Takeda; results first posted 2011-07-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan. Trials, record NCT01263470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263470
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
- NCT number
- NCT01263470
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 480 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Alogliptin, Alogliptin, Alogliptin, Alogliptin, Voglibose, Placebo
- First posted
- 2010-12-20
- Last updated
- 2012-02-03
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 or final visit and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 2). | Baseline and Week 2. | 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 2 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 4). | Baseline and Week 4. | 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 4 and glycosylated hemoglobin collected at baseline. |
| 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 Fasting Plasma Glucose (Week 2). | Baseline and Week 2 | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 4). | Baseline and Week 4. | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 8). | Baseline and Week 8. | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 12). | Baseline and Week 12. | The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting C-peptide (Week 2). | Baseline and Week 2. | The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline. |
| Secondary | Change From Baseline in Fasting C-peptide (Week 4). | Baseline and Week 4. | The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 2). | Baseline and Week 2. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 4). | Baseline and Week 4. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | percentage of Glycosylated Hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 2). | Baseline and Week 2 | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 4). | Baseline and Week 4. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 8). | Baseline and Week 8. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 12). | Baseline and Week 12. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting C-peptide (Week 2). | Baseline and Week 2. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | ng/mL | MEAN |
| SECONDARY | Change From Baseline in Fasting C-peptide (Week 4). | Baseline and Week 4. | Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set. | ng/mL | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Placebo | 0.06 | Standard Deviation 0.456 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Alogliptin 6.25 mg QD | -0.51 | Standard Deviation 0.677 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Alogliptin 12.5 mg QD | -0.70 | Standard Deviation 0.572 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Alogliptin 25 mg QD | -0.76 | Standard Deviation 0.547 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Alogliptin 50 mg QD | -0.82 | Standard Deviation 0.474 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Voglibose 0.2 mg TID | -0.16 | Standard Deviation 0.730 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Placebo | 0.00 | Standard Deviation 0.187 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Alogliptin 6.25 mg QD | -0.16 | Standard Deviation 0.153 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Alogliptin 12.5 mg QD | -0.17 | Standard Deviation 0.194 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Alogliptin 25 mg QD | -0.16 | Standard Deviation 0.187 | percentage of Glycosylated Hemoglobin |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | STARTED | Alogliptin 6.25 mg QD | 79 | |
| Overall Study | STARTED | Alogliptin 12.5 mg QD | 84 | |
| Overall Study | STARTED | Alogliptin 25 mg QD | 80 | |
| Overall Study | STARTED | Alogliptin 50 mg QD | 79 | |
| Overall Study | STARTED | Voglibose 0.2 mg TID | 83 | |
| Overall Study | COMPLETED | Placebo | 73 | |
| Overall Study | COMPLETED | Alogliptin 6.25 mg QD | 74 | |
| Overall Study | COMPLETED | Alogliptin 12.5 mg QD | 80 | |
| Overall Study | COMPLETED | Alogliptin 25 mg QD | 77 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events138
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 | Flatulence | Gastrointestinal disorders | Placebo | 2 | 75 | |
| other | Flatulence | Gastrointestinal disorders | Alogliptin 6.25 mg QD | 2 | 79 | |
| other | Flatulence | Gastrointestinal disorders | Alogliptin 12.5 mg QD | 4 | 84 | |
| other | Flatulence | Gastrointestinal disorders | Alogliptin 25 mg QD | 1 | 80 | |
| other | Flatulence | Gastrointestinal disorders | Alogliptin 50 mg QD | 1 | 79 | |
| other | Flatulence | Gastrointestinal disorders | Voglibose 0.2 mg TID | 8 | 83 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 75 | |
| other | Abdominal distension | Gastrointestinal disorders | Alogliptin 6.25 mg QD | 1 | 79 | |
| other | Abdominal distension | Gastrointestinal disorders | Alogliptin 12.5 mg QD | 2 | 84 | |
| other | Abdominal distension | Gastrointestinal disorders | Alogliptin 25 mg QD | 3 | 80 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Alogliptin 6.25 mg QD | ||
| Total, all-cause mortality | Alogliptin 12.5 mg QD | ||
| Total, all-cause mortality | Alogliptin 25 mg QD | ||
| Total, all-cause mortality | Alogliptin 50 mg QD | ||
| Total, all-cause mortality | Voglibose 0.2 mg TID | ||
| Total, other adverse events | Placebo | 20 | 75 |
| Total, other adverse events | Alogliptin 6.25 mg QD | 17 | 79 |
| Total, other adverse events | Alogliptin 12.5 mg QD | 23 | 84 |
| Total, other adverse events | Alogliptin 25 mg QD | 27 | 80 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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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