Trial · NCT01318083
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
NCT01318083, Phase 2, Phase 3, 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 Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan. Trials, record NCT01318083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01318083
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
- NCT number
- NCT01318083
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 312 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Alogliptin and glimepiride, Alogliptin and glimepiride, Glimepiride
- First posted
- 2011-03-18
- Last updated
- 2012-02-03
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes9
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 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 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 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 baseline. |
| Secondary | Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). | Baseline and Week 12. | The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal. |
Source ClinicalTrials.gov
Outcomes9
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 Blood Glucose Measured by the Meal Tolerance Test (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 |
Source ClinicalTrials.gov
Results by group27
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). | Alogliptin 12.5 mg QD and Glimepiride QD or BID | -0.60 | Standard Deviation 0.563 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Alogliptin 25 mg QD and Glimepiride QD or BID | -0.66 | Standard Deviation 0.564 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Glimepiride 1, 2, 3 or 4 mg QD or BID | 0.34 | Standard Deviation 0.611 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Alogliptin 12.5 mg QD and Glimepiride QD or BID | -0.12 | Standard Deviation 0.244 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Alogliptin 25 mg QD and Glimepiride QD or BID | -0.13 | Standard Deviation 0.206 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 2). | Glimepiride 1, 2, 3 or 4 mg QD or BID | 0.08 | Standard Deviation 0.229 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Alogliptin 12.5 mg QD and Glimepiride QD or BID | -0.32 | Standard Deviation 0.357 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Alogliptin 25 mg QD and Glimepiride QD or BID | -0.36 | Standard Deviation 0.339 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Glimepiride 1, 2, 3 or 4 mg QD or BID | 0.09 | Standard Deviation 0.351 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Alogliptin 12.5 mg QD and Glimepiride QD or BID | -0.52 | Standard Deviation 0.488 | percentage of Glycosylated Hemoglobin |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 105 | |
| Overall Study | STARTED | Alogliptin 25 mg QD and Glimepiride QD or BID | 104 | |
| Overall Study | STARTED | Glimepiride 1, 2, 3 or 4 mg QD or BID | 103 | |
| Overall Study | COMPLETED | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 99 | |
| Overall Study | COMPLETED | Alogliptin 25 mg QD and Glimepiride QD or BID | 102 | |
| Overall Study | COMPLETED | Glimepiride 1, 2, 3 or 4 mg QD or BID | 98 | |
| Overall Study | NOT COMPLETED | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 6 | |
| Overall Study | NOT COMPLETED | Alogliptin 25 mg QD and Glimepiride QD or BID | 2 | |
| Overall Study | NOT COMPLETED | Glimepiride 1, 2, 3 or 4 mg QD or BID | 5 |
Source ClinicalTrials.gov
Adverse events30
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 | Nasopharyngitis | Infections and infestations | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 20 | 105 | |
| other | Nasopharyngitis | Infections and infestations | Alogliptin 25 mg QD and Glimepiride QD or BID | 20 | 104 | |
| other | Nasopharyngitis | Infections and infestations | Glimepiride 1, 2, 3 or 4 mg QD or BID | 22 | 103 | |
| other | Headache | Nervous system disorders | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 0 | 105 | |
| other | Headache | Nervous system disorders | Alogliptin 25 mg QD and Glimepiride QD or BID | 2 | 104 | |
| other | Headache | Nervous system disorders | Glimepiride 1, 2, 3 or 4 mg QD or BID | 4 | 103 | |
| other | Fall | Injury, poisoning and procedural complications | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 1 | 105 | |
| other | Fall | Injury, poisoning and procedural complications | Alogliptin 25 mg QD and Glimepiride QD or BID | 2 | 104 | |
| other | Fall | Injury, poisoning and procedural complications | Glimepiride 1, 2, 3 or 4 mg QD or BID | 4 | 103 | |
| other | Gastroenteritis | Infections and infestations | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 4 | 105 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alogliptin 12.5 mg QD and Glimepiride QD or BID | ||
| Total, all-cause mortality | Alogliptin 25 mg QD and Glimepiride QD or BID | ||
| Total, all-cause mortality | Glimepiride 1, 2, 3 or 4 mg QD or BID | ||
| Total, other adverse events | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 27 | 105 |
| Total, other adverse events | Alogliptin 25 mg QD and Glimepiride QD or BID | 40 | 104 |
| Total, other adverse events | Glimepiride 1, 2, 3 or 4 mg QD or BID | 36 | 103 |
| Total, serious adverse events | Alogliptin 12.5 mg QD and Glimepiride QD or BID | 3 | 105 |
| Total, serious adverse events | Alogliptin 25 mg QD and Glimepiride QD or BID | 1 | 104 |
| Total, serious adverse events | Glimepiride 1, 2, 3 or 4 mg QD or BID | 0 | 103 |
Source ClinicalTrials.gov
Papers1
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.
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/NCT01318083
GET https://conductscience.org/api/trials/v1/NCT01318083/results?page=2