Trial · NCT00856284
Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
NCT00856284, Phase 3, Completed, Takeda; results first posted 2013-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus. Trials, record NCT00856284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00856284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT00856284
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,639 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Alogliptin, Metformin, Glipizide
- First posted
- 2009-03-05
- Last updated
- 2013-12-03
- Other registries' IDs
- eudract:2008-007444-34
- Results first posted
- 2013-12-03
- Limitations and caveats
The Week 52 results summarized in herein differ from the Week 52 results summarized in an interim analysis, because the per protocol set (PPS) defined for the final analysis included fewer subjects than the PPS defined for the interim analysis.
Source ClinicalTrials.gov
Registered outcomes7
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 52 | Baseline and Week 52 | The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates. |
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 | Baseline and Week 104 | The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91. | The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates. |
| Secondary | Change From Baseline in Fasting Plasma Glucose Over Time | Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. | The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates. |
| Secondary | Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% | Weeks 26, 52, 78, and 104. | The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation. |
| Secondary | Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% | Weeks 26, 52, 78, and 104. | Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation. |
| Secondary | Change From Baseline in Body Weight Over Time | Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104. | LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates. |
Source ClinicalTrials.gov
Outcomes7
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 52 | Baseline and Week 52 | The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward (LOCF) was used. | percentage glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91. | Per-protocol set; LOCF was used. | percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose Over Time | Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. | Full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug who had a Baseline assessment and at least 1 post-baseline assessment for FPG. LOCF was used. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% | Weeks 26, 52, 78, and 104. | Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% | Weeks 26, 52, 78, and 104. | Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight Over Time | Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104. | Full analysis set, LOCF was used. | kg | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 | Baseline and Week 104 | The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward was used (LOCF). | percentage glycosylated hemoglobin | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group123
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 52 | Metformin + Alogliptin 12.5 mg | -0.81 | Standard Error 0.027 | percentage glycosylated hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | Metformin + Alogliptin 25 mg | -0.76 | Standard Error 0.027 | percentage glycosylated hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | Metformin + Glipizide | -0.73 | Standard Error 0.029 | percentage glycosylated hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Alogliptin 12.5 mg | Week 4 (n=341, 354, 318) | -0.37 | Standard Error 0.020 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Alogliptin 25 mg | Week 4 (n=341, 354, 318) | -0.40 | Standard Error 0.020 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Glipizide | Week 4 (n=341, 354, 318) | -0.41 | Standard Error 0.021 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Alogliptin 12.5 mg | Week 8 (n=370, 382, 336) | -0.56 | Standard Error 0.024 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Alogliptin 25 mg | Week 8 (n=370, 382, 336) | -0.60 | Standard Error 0.024 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Glipizide | Week 8 (n=370, 382, 336) | -0.66 | Standard Error 0.025 | percentage of glycosylated hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin at Other Time Points | Metformin + Alogliptin 12.5 mg | Week 12 (n=371, 382, 336) | -0.69 | Standard Error 0.025 | percentage of glycosylated hemoglobin |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin + Alogliptin 12.5 mg | 880 | |
| Overall Study | STARTED | Metformin + Alogliptin 25 mg | 885 | |
| Overall Study | STARTED | Metformin + Glipizide | 874 | |
| Overall Study | Received Study Drug | Metformin + Alogliptin 12.5 mg | 873 | |
| Overall Study | Received Study Drug | Metformin + Alogliptin 25 mg | 878 | |
| Overall Study | Received Study Drug | Metformin + Glipizide | 869 | |
| Overall Study | COMPLETED | Metformin + Alogliptin 12.5 mg | 472 | |
| Overall Study | COMPLETED | Metformin + Alogliptin 25 mg | 493 | |
| Overall Study | COMPLETED | Metformin + Glipizide | 427 | |
| Overall Study | NOT COMPLETED | Metformin + Alogliptin 12.5 mg | 408 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events696
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 | Diarrhoea | Gastrointestinal disorders | Metformin + Alogliptin 12.5 mg | 60 | 873 | |
| other | Diarrhoea | Gastrointestinal disorders | Metformin + Alogliptin 25 mg | 60 | 878 | |
| other | Diarrhoea | Gastrointestinal disorders | Metformin + Glipizide | 63 | 869 | |
| other | Upper respiratory tract infection | Infections and infestations | Metformin + Alogliptin 12.5 mg | 84 | 873 | |
| other | Upper respiratory tract infection | Infections and infestations | Metformin + Alogliptin 25 mg | 90 | 878 | |
| other | Upper respiratory tract infection | Infections and infestations | Metformin + Glipizide | 76 | 869 | |
| other | Nasopharyngitis | Infections and infestations | Metformin + Alogliptin 12.5 mg | 78 | 873 | |
| other | Nasopharyngitis | Infections and infestations | Metformin + Alogliptin 25 mg | 67 | 878 | |
| other | Nasopharyngitis | Infections and infestations | Metformin + Glipizide | 61 | 869 | |
| other | Anaemia | Blood and lymphatic system disorders | Metformin + Alogliptin 12.5 mg | 16 | 873 |
1 to 10 of 696Source ClinicalTrials.gov
See all 696 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin + Alogliptin 12.5 mg | ||
| Total, all-cause mortality | Metformin + Alogliptin 25 mg | ||
| Total, all-cause mortality | Metformin + Glipizide | ||
| Total, other adverse events | Metformin + Alogliptin 12.5 mg | 688 | 873 |
| Total, other adverse events | Metformin + Alogliptin 25 mg | 687 | 878 |
| Total, other adverse events | Metformin + Glipizide | 668 | 869 |
| Total, serious adverse events | Metformin + Alogliptin 12.5 mg | 86 | 873 |
| Total, serious adverse events | Metformin + Alogliptin 25 mg | 97 | 878 |
| Total, serious adverse events | Metformin + Glipizide | 81 | 869 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27787778 | 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/NCT00856284
GET https://conductscience.org/api/trials/v1/NCT00856284/results?page=2