Trial · NCT00328627
Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
NCT00328627, Phase 3, Completed, Takeda; results first posted 2013-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus. Trials, record NCT00328627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00328627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
- NCT number
- NCT00328627
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,554 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Alogliptin, Alogliptin placebo, Pioglitazone, Pioglitazone placebo
- First posted
- 2006-05-22
- Last updated
- 2013-04-04
- Other registries' IDs
- eudract:2006-000694-30
- Results first posted
- 2013-04-04
Source ClinicalTrials.gov
Registered outcomes156
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | Baseline and Week 26 | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone). |
| Primary | Change From Baseline to Week 26 in HbA1c | Baseline and Week 26 | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). |
| Secondary | Change From Baseline in HbA1c Over Time (Grouped Analysis) | Baseline and Weeks 4, 8, 12, 16 and 20. | The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates. |
| Secondary | Change From Baseline to Week 4 in HbA1c | Baseline and Week 4 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
| Secondary | Change From Baseline to Week 8 in HbA1c | Baseline and Week 8 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
| Secondary | Change From Baseline to Week 12 in HbA1c | Baseline and Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
| Secondary | Change From Baseline to Week 16 in HbA1c | Baseline and Week 16 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
| Secondary | Change From Baseline to Week 20 in HbA1c | Baseline and Week 20 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
| Secondary | Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis) | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. | The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. |
| Secondary | Change From Baseline to Week 1 in Fasting Plasma Glucose | Baseline and Week 1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 registered outcomesOutcomes156
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | Baseline and Week 26 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c Over Time (Grouped Analysis) | Baseline and Weeks 4, 8, 12, 16 and 20. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in HbA1c | Baseline and Week 4 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in HbA1c | Baseline and Week 8 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in HbA1c | Baseline and Week 12 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in HbA1c | Baseline and Week 16 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 20 in HbA1c | Baseline and Week 20 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis) | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 1 in Fasting Plasma Glucose | Baseline and Week 1 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 2 in Fasting Plasma Glucose | Baseline and Week 2 | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | mg/dL | LEAST_SQUARES_MEAN |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 outcomesResults by group1,995
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | Pioglitazone Alone | -0.89 | Standard Error 0.046 | percentage of glycosylated hemoglobin | |
| Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | Alogliptin 12.5 + Pioglitazone | -1.43 | Standard Error 0.046 | percentage of glycosylated hemoglobin | |
| Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | Alogliptin 25 + Pioglitazone | -1.42 | Standard Error 0.046 | percentage of glycosylated hemoglobin | |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Pioglitazone Alone | Week 4 (n=345, 359, 346) | -0.32 | Standard Error 0.023 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Alogliptin 12.5 + Pioglitazone | Week 4 (n=345, 359, 346) | -0.57 | Standard Error 0.023 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Alogliptin 25 + Pioglitazone | Week 4 (n=345, 359, 346) | -0.61 | Standard Error 0.023 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Pioglitazone Alone | Week 8 (n=376, 385, 377) | -0.61 | Standard Error 0.034 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Alogliptin 12.5 + Pioglitazone | Week 8 (n=376, 385, 377) | -1.06 | Standard Error 0.033 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Alogliptin 25 + Pioglitazone | Week 8 (n=376, 385, 377) | -1.09 | Standard Error 0.034 | percentage of glycosylated hemoglobin |
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | Pioglitazone Alone | Week 12 (n=376, 385, 377) | -0.81 | Standard Error 0.039 | percentage of glycosylated hemoglobin |
1 to 10 of 1,995Source ClinicalTrials.gov
See all 1,995 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 129 | |
| Overall Study | STARTED | Alogliptin 12.5 + Placebo | 128 | |
| Overall Study | STARTED | Alogliptin 25 + Placebo | 129 | |
| Overall Study | STARTED | Placebo + Pioglitazone 15 | 130 | |
| Overall Study | STARTED | Alogliptin 12.5 + Pioglitazone 15 | 130 | |
| Overall Study | STARTED | Alogliptin 25 + Pioglitazone 15 | 130 | |
| Overall Study | STARTED | Placebo + Pioglitazone 30 | 129 | |
| Overall Study | STARTED | Alogliptin 12.5 + Pioglitazone 30 | 130 | |
| Overall Study | STARTED | Alogliptin 25 + Pioglitazone 30 | 130 | |
| Overall Study | STARTED | Placebo + Pioglitazone 45 | 129 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events744
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 | Headache | Nervous system disorders | Placebo | 6 | 129 | |
| other | Headache | Nervous system disorders | Alogliptin 12.5 + Placebo | 5 | 128 | |
| other | Headache | Nervous system disorders | Alogliptin 25 + Placebo | 9 | 129 | |
| other | Headache | Nervous system disorders | Placebo + Pioglitazone 15 | 16 | 129 | |
| other | Headache | Nervous system disorders | Alogliptin 12.5 + Pioglitazone 15 | 5 | 130 | |
| other | Headache | Nervous system disorders | Alogliptin 25 + Pioglitazone 15 | 3 | 130 | |
| other | Headache | Nervous system disorders | Placebo + Pioglitazone 30 | 2 | 129 | |
| other | Headache | Nervous system disorders | Alogliptin 12.5 + Pioglitazone 30 | 2 | 130 | |
| other | Headache | Nervous system disorders | Alogliptin 25 + Pioglitazone 30 | 5 | 130 | |
| other | Headache | Nervous system disorders | Placebo + Pioglitazone 45 | 5 | 129 |
1 to 10 of 744Source ClinicalTrials.gov
See all 744 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Alogliptin 12.5 + Placebo | ||
| Total, all-cause mortality | Alogliptin 25 + Placebo | ||
| Total, all-cause mortality | Placebo + Pioglitazone 15 | ||
| Total, all-cause mortality | Alogliptin 12.5 + Pioglitazone 15 | ||
| Total, all-cause mortality | Alogliptin 25 + Pioglitazone 15 | ||
| Total, all-cause mortality | Placebo + Pioglitazone 30 | ||
| Total, all-cause mortality | Alogliptin 12.5 + Pioglitazone 30 | ||
| Total, all-cause mortality | Alogliptin 25 + Pioglitazone 30 | ||
| Total, all-cause mortality | Placebo + Pioglitazone 45 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22419732 | RESULT |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00328627
GET https://conductscience.org/api/trials/v1/NCT00328627/registered?page=2