Trial · NCT00654381
Japanese P III vs Voglibose and Placebo
NCT00654381, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Japanese P III vs Voglibose and Placebo. Trials, record NCT00654381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654381
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Japanese P III vs Voglibose and Placebo
- NCT number
- NCT00654381
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- BI 1356, BI 1356, voglibose placebo, BI 1356 placebo, voglibose
- First posted
- 2008-04-08
- Last updated
- 2014-01-27
- Results first posted
- 2011-08-02
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 HbA1c at Week 12 | 12 weeks | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication |
| Primary | Change From Baseline in HbA1c at Week 26 | 26 weeks | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication |
| Primary | Examination of Long-term Safety of Linagliptin (52-week Treatment) | 52 weeks | The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks |
| Secondary | Relative Efficacy Response of HbA1c at Week 12 | 12 weeks | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12 |
| Secondary | Relative Efficacy Response of HbA1c at Week 26 | 26 weeks | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26 |
| Secondary | Relative Efficacy Response of HbA1c at Week 52 | 52 weeks | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52 |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | 12 weeks | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | 26 weeks | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | 52 weeks | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication |
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 HbA1c at Week 12 | 12 weeks | For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward. | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in HbA1c at Week 26 | 26 weeks | For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Relative Efficacy Response of HbA1c at Week 12 | 12 weeks | For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward. | Participants | NUMBER |
| SECONDARY | Relative Efficacy Response of HbA1c at Week 26 | 26 weeks | For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward. | Participants | NUMBER |
| SECONDARY | Relative Efficacy Response of HbA1c at Week 52 | 52 weeks | For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward | Participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | 12 weeks | For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | 26 weeks | For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | 52 weeks | The patients who had at least one available baseline FPG measurement under the treatment with linagliptin | mg/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Examination of Long-term Safety of Linagliptin (52-week Treatment) | 52 weeks | The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period | participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
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 HbA1c at Week 12 | Placebo | 0.63 | Standard Error 0.08 | Percent | |
| Change From Baseline in HbA1c at Week 12 | Linagliptin 5mg | -0.24 | Standard Error 0.06 | Percent | |
| Change From Baseline in HbA1c at Week 12 | Linagliptin 10 mg | -0.25 | Standard Error 0.06 | Percent | |
| Change From Baseline in HbA1c at Week 26 | Linagliptin 5mg | -0.13 | Standard Error 0.07 | Percent | |
| Change From Baseline in HbA1c at Week 26 | Linagliptin 10 mg | -0.19 | Standard Error 0.07 | Percent | |
| Change From Baseline in HbA1c at Week 26 | Voglibose | 0.19 | Standard Error 0.07 | Percent | |
| Relative Efficacy Response of HbA1c at Week 12 | Placebo | HbA1c <7.0% | 8 | Participants | |
| Relative Efficacy Response of HbA1c at Week 12 | Linagliptin 5mg | HbA1c <7.0% | 42 | Participants | |
| Relative Efficacy Response of HbA1c at Week 12 | Linagliptin 10 mg | HbA1c <7.0% | 56 | Participants | |
| Relative Efficacy Response of HbA1c at Week 12 | Placebo | HbA1c <6.5% | 0 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Stage | STARTED | Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg | 39 | |
| 1st Stage | STARTED | Placebo - Linagliptin 5mg - Linagliptin 10mg | 41 | |
| 1st Stage | STARTED | Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg | 159 | |
| 1st Stage | STARTED | Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg | 160 | |
| 1st Stage | STARTED | Voglibose - Voglibose - Linagliptin 5mg | 81 | |
| 1st Stage | STARTED | Voglibose - Voglibose - Linagliptin 10mg | 81 | |
| 1st Stage | COMPLETED | Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg | 36 | |
| 1st Stage | COMPLETED | Placebo - Linagliptin 5mg - Linagliptin 10mg | 38 | |
| 1st Stage | COMPLETED | Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg | 156 | |
| 1st Stage | COMPLETED | Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg | 155 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events512
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 | Placebo (1st Stage) | 10 | 80 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 5mg (2nd-Extension Stage After Placebo) | 10 | 36 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 10mg (2nd-Extension Stage After Placebo) | 8 | 38 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 5mg (1st-2nd-Extension Stage) | 60 | 159 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 10mg (1st-2nd-Extension Stage) | 57 | 160 | |
| other | Nasopharyngitis | Infections and infestations | Voglibose (1st-2nd Stage) | 36 | 162 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 5mg (Extension Stage After Voglibose) | 14 | 71 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin 10mg (Extension Stage After Voglibose) | 16 | 76 | |
| other | Rhinitis | Infections and infestations | Placebo (1st Stage) | 0 | 80 | |
| other | Rhinitis | Infections and infestations | Linagliptin 5mg (2nd-Extension Stage After Placebo) | 2 | 36 |
1 to 10 of 512Source ClinicalTrials.gov
See all 512 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (1st Stage) | ||
| Total, all-cause mortality | Linagliptin 5mg (2nd-Extension Stage After Placebo) | ||
| Total, all-cause mortality | Linagliptin 10mg (2nd-Extension Stage After Placebo) | ||
| Total, all-cause mortality | Linagliptin 5mg (1st-2nd-Extension Stage) | ||
| Total, all-cause mortality | Linagliptin 10mg (1st-2nd-Extension Stage) | ||
| Total, all-cause mortality | Voglibose (1st-2nd Stage) | ||
| Total, all-cause mortality | Linagliptin 5mg (Extension Stage After Voglibose) | ||
| Total, all-cause mortality | Linagliptin 10mg (Extension Stage After Voglibose) | ||
| Total, other adverse events | Placebo (1st Stage) | 23 | 80 |
| Total, other adverse events | Linagliptin 5mg (2nd-Extension Stage After Placebo) | 19 | 36 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
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/NCT00654381
GET https://conductscience.org/api/trials/v1/NCT00654381/results?page=2