Trial · NCT00286468
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
NCT00286468, Phase 3, Completed, Takeda; results first posted 2011-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus. Trials, record NCT00286468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00286468
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
- NCT number
- NCT00286468
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 500 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus
- Interventions
- Alogliptin and glyburide, Alogliptin and glyburide, Glyburide
- First posted
- 2006-02-03
- Last updated
- 2012-02-03
- Other registries' IDs
- eudract:2005-004667-36
- Results first posted
- 2011-08-25
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | Baseline and Week 26. | 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 26 or final visit 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 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 Fasting Plasma Glucose (Week 1). | Baseline and Week 1. | The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose 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. |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
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 (HbA1c) at Week 26. | Baseline and Week 26. | Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 4). | Baseline and Week 4. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at week 4 due to unavailable prior value to carry forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and Week 16. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and Week 20. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 1). | Baseline and Week 1. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 2). | Baseline and Week 2. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 4). | Baseline and Week 4. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (Week 8). | Baseline and Week 8. | Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). | mg/dL | LEAST_SQUARES_MEAN |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group153
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 (HbA1c) at Week 26. | Placebo | 0.01 | Standard Error 0.084 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | Alogliptin 12.5 mg QD | -0.38 | Standard Error 0.058 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | Alogliptin 25 mg QD | -0.52 | Standard Error 0.058 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Placebo | -0.18 | Standard Error 0.042 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Alogliptin 12.5 mg QD | -0.40 | Standard Error 0.028 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Alogliptin 25 mg QD | -0.46 | Standard Error 0.029 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Placebo | -0.18 | Standard Error 0.057 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Alogliptin 12.5 mg QD | -0.57 | Standard Error 0.040 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Alogliptin 25 mg QD | -0.65 | Standard Error 0.040 | mg/dL | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Placebo | -0.17 | Standard Error 0.068 | mg/dL |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 99 | |
| Overall Study | STARTED | Alogliptin 12.5 mg QD | 203 | |
| Overall Study | STARTED | Alogliptin 25 mg QD | 198 | |
| Overall Study | COMPLETED | Placebo | 62 | |
| Overall Study | COMPLETED | Alogliptin 12.5 mg QD | 153 | |
| Overall Study | COMPLETED | Alogliptin 25 mg QD | 148 | |
| Overall Study | NOT COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Alogliptin 12.5 mg QD | 50 | |
| Overall Study | NOT COMPLETED | Alogliptin 25 mg QD | 50 |
Source ClinicalTrials.gov
Adverse events105
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 | Upper respiratory tract infection | Infections and infestations | Placebo | 6 | 99 | |
| other | Upper respiratory tract infection | Infections and infestations | Alogliptin 12.5 mg QD | 4 | 203 | |
| other | Upper respiratory tract infection | Infections and infestations | Alogliptin 25 mg QD | 5 | 198 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 99 | |
| other | Headache | Nervous system disorders | Alogliptin 12.5 mg QD | 5 | 203 | |
| other | Headache | Nervous system disorders | Alogliptin 25 mg QD | 11 | 198 | |
| other | Hypertension | Vascular disorders | Placebo | 2 | 99 | |
| other | Hypertension | Vascular disorders | Alogliptin 12.5 mg QD | 7 | 203 | |
| other | Hypertension | Vascular disorders | Alogliptin 25 mg QD | 11 | 198 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 3 | 99 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals9
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 mg QD | ||
| Total, all-cause mortality | Alogliptin 25 mg QD | ||
| Total, other adverse events | Placebo | 23 | 99 |
| Total, other adverse events | Alogliptin 12.5 mg QD | 49 | 203 |
| Total, other adverse events | Alogliptin 25 mg QD | 64 | 198 |
| Total, serious adverse events | Placebo | 2 | 99 |
| Total, serious adverse events | Alogliptin 12.5 mg QD | 11 | 203 |
| Total, serious adverse events | Alogliptin 25 mg QD | 11 | 198 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00286468
GET https://conductscience.org/api/trials/v1/NCT00286468/registered?page=2