Trial · NCT01945242
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
NCT01945242, Completed, Takeda; results first posted 2016-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones". Trials, record NCT01945242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01945242
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
- NCT number
- NCT01945242
- Status
- Completed
- Enrollment
- 1,374 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Melitus
- Interventions
- Alogliptin
- First posted
- 2013-09-18
- Last updated
- 2016-09-27
- Results first posted
- 2016-09-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to 12 months | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. |
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to 12 months | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Secondary | Percentage of Participants of Achieving Objective Glycemic Control | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0 percent, \<7.0 percent, and \<6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Secondary | Change From Baseline in Fasting Blood Glucose | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Secondary | Change From Baseline in Fasting Insulin | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to 12 months | The safety analysis set was defined as all participants who were enrolled and completed the study. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to 12 months | The safety analysis set was defined as all participants who were enrolled and completed the study. | participants | NUMBER |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | percentage of glycosylated hemoglobin | MEAN |
| SECONDARY | Percentage of Participants of Achieving Objective Glycemic Control | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Blood Glucose | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Thiazolidinedione | Hypothyroidism | 1 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Other | Hypothyroidism | 0 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Thiazolidinedione | Hyperglycaemia | 1 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Other | Hyperglycaemia | 0 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Thiazolidinedione | Hypoglycaemia | 5 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Other | Hypoglycaemia | 1 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Thiazolidinedione | Dyslipidaemia | 1 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Other | Dyslipidaemia | 0 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Thiazolidinedione | Dizziness | 3 | participants | |
| Number of Participants Reporting One or More Adverse Drug Reactions | Alogliptin + Other | Dizziness | 0 | participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alogliptin + Thiazolidinedione | 1,251 | |
| Overall Study | STARTED | Alogliptin + Other | 123 | |
| Overall Study | COMPLETED | Alogliptin + Thiazolidinedione | 1,248 | |
| Overall Study | COMPLETED | Alogliptin + Other | 120 | |
| Overall Study | NOT COMPLETED | Alogliptin + Thiazolidinedione | 3 | |
| Overall Study | NOT COMPLETED | Alogliptin + Other | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Diabetes mellitus | Metabolism and nutrition disorders | Alogliptin + Thiazolidinedione | 11 | 1,248 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Alogliptin + Other | 2 | 120 | |
| serious | Hyperglycaemia | Metabolism and nutrition disorders | Alogliptin + Thiazolidinedione | 1 | 1,248 | |
| serious | Hyperglycaemia | Metabolism and nutrition disorders | Alogliptin + Other | 0 | 120 | |
| serious | Hypoglycaemia | Metabolism and nutrition disorders | Alogliptin + Thiazolidinedione | 2 | 1,248 | |
| serious | Hypoglycaemia | Metabolism and nutrition disorders | Alogliptin + Other | 0 | 120 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alogliptin + Thiazolidinedione | ||
| Total, all-cause mortality | Alogliptin + Other | ||
| Total, other adverse events | Alogliptin + Thiazolidinedione | 11 | 1,248 |
| Total, other adverse events | Alogliptin + Other | 2 | 120 |
| Total, serious adverse events | Alogliptin + Thiazolidinedione | 3 | 1,248 |
| Total, serious adverse events | Alogliptin + Other | 0 | 120 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alogliptin + Thiazolidinedione vs Alogliptin + Other: serious adverse events |
Source Trial comparisons
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/NCT01945242
GET https://conductscience.org/api/trials/v1/NCT01945242/results?page=2