Trial · NCT00707993
Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
NCT00707993, Phase 3, Completed, Takeda; results first posted 2013-05-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics. Trials, record NCT00707993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00707993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
- NCT number
- NCT00707993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 441 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus
- Interventions
- Alogliptin, Glipizide
- First posted
- 2008-07-02
- Last updated
- 2013-05-24
- Other registries' IDs
- eudract:2008-000959-10
- Results first posted
- 2013-05-24
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin at Week 52. | Baseline and Week 52. | The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42. | 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 each week indicated including final visit relative to baseline. |
| Secondary | Incidence of Hypoglycemia | On occurrence (up to 52 weeks). | Percentage of participants with at least one hypoglycemic episode during 52 week study. |
| Secondary | Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL). | On Occurrence (up to 52 weeks). | The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study. |
| Secondary | Incidence of Hyperglycemic Rescue | On Occurrence (up to 52 weeks). | The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study. |
| Secondary | Change From Baseline in Fasting Plasma Glucose | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52. | The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in 2-hour Postprandial Glucose | Baseline and Week 52. | The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink. |
| Secondary | Change From Baseline in Fasting Proinsulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in Insulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the value of insulin collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in Proinsulin/Insulin Ratio | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 at Week 52. | Baseline and Week 52. | Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF). | percentage of Glycosylated Hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42. | Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF). | percentage of Glycosylated Hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Hypoglycemia | On occurrence (up to 52 weeks). | Percentages based on the number of Safety Set participants in each treatment group. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL). | On Occurrence (up to 52 weeks). | All randomized participants who had at least 1 dose of study medication (full analysis set). | participants | NUMBER |
| SECONDARY | Incidence of Hyperglycemic Rescue | On Occurrence (up to 52 weeks). | All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Glucose | Baseline and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Proinsulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mcIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Proinsulin/Insulin Ratio | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | ratio | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group186
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 at Week 52. | Alogliptin 25 mg QD | -0.14 | Standard Error 0.063 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin at Week 52. | Glipizide 5 mg QD | -0.09 | Standard Error 0.067 | percentage of Glycosylated Hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin | Alogliptin 25 mg QD | Week 4 (n=175; n=148) | -0.14 | Standard Error 0.047 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Glipizide 5 mg QD | Week 4 (n=175; n=148) | -0.11 | Standard Error 0.051 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Alogliptin 25 mg QD | Week 8 (n=180; n=161) | -0.27 | Standard Error 0.051 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Glipizide 5 mg QD | Week 8 (n=180; n=161) | -0.23 | Standard Error 0.054 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Alogliptin 25 mg QD | Week 12 (n=180; n=162) | -0.34 | Standard Error 0.053 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Glipizide 5 mg QD | Week 12 (n=180; n=162) | -0.25 | Standard Error 0.055 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Alogliptin 25 mg QD | Week 16 (n=180; n=162) | -0.31 | Standard Error 0.050 | percentage of Glycosylated Hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin | Glipizide 5 mg QD | Week 16 (n=180; n=162) | -0.32 | Standard Error 0.052 | percentage of Glycosylated Hemoglobin |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 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 25 mg QD | 222 | |
| Overall Study | STARTED | Glipizide 5 mg QD | 219 | |
| Overall Study | COMPLETED | Alogliptin 25 mg QD | 133 | |
| Overall Study | COMPLETED | Glipizide 5 mg QD | 125 | |
| Overall Study | NOT COMPLETED | Alogliptin 25 mg QD | 89 | |
| Overall Study | NOT COMPLETED | Glipizide 5 mg QD | 94 |
Source ClinicalTrials.gov
Adverse events100
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Alogliptin 25 mg QD | 10 | 222 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Glipizide 5 mg QD | 12 | 219 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Alogliptin 25 mg QD | 9 | 222 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Glipizide 5 mg QD | 11 | 219 | |
| other | Bronchitis | Infections and infestations | Alogliptin 25 mg QD | 6 | 222 | |
| other | Bronchitis | Infections and infestations | Glipizide 5 mg QD | 9 | 219 | |
| other | C-reactive protein increased | Investigations | Alogliptin 25 mg QD | 9 | 222 | |
| other | C-reactive protein increased | Investigations | Glipizide 5 mg QD | 3 | 219 | |
| other | Diarrhoea | Gastrointestinal disorders | Alogliptin 25 mg QD | 9 | 222 | |
| other | Diarrhoea | Gastrointestinal disorders | Glipizide 5 mg QD | 14 | 219 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alogliptin 25 mg QD | ||
| Total, all-cause mortality | Glipizide 5 mg QD | ||
| Total, other adverse events | Alogliptin 25 mg QD | 103 | 222 |
| Total, other adverse events | Glipizide 5 mg QD | 105 | 219 |
| Total, serious adverse events | Alogliptin 25 mg QD | 16 | 222 |
| Total, serious adverse events | Glipizide 5 mg QD | 13 | 219 |
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 25 mg QD vs Glipizide 5 mg QD: 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/NCT00707993
GET https://conductscience.org/api/trials/v1/NCT00707993/results?page=2