Trial · NCT00740051
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
NCT00740051, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate. Trials, record NCT00740051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00740051
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
- NCT number
- NCT00740051
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 227 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Linagliptin, Linagliptin Placebo, Glimepiride
- First posted
- 2008-08-22
- Last updated
- 2014-06-27
- Other registries' IDs
- eudract:2007-007485-38
- Results first posted
- 2011-10-26
- Limitations and caveats
- Primary analysis (at interim) was rerun using final study database
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HbA1c Change From Baseline at Week 18 (Interim Analysis) | Baseline and week 18 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. |
| Primary | HbA1c Change From Baseline at Week 18 (Final Analysis) | Baseline and week 18 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report. |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | Baseline and week 18 | This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis). |
| Secondary | Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) | Week 18 | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. |
| Secondary | Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Week 18 | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. |
| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) | Week 18 | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. |
| Secondary | The Change in HbA1c From Baseline by Visit Over Time | Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent. |
| Secondary | The Change in FPG From Baseline by Visit Over Time | Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 | This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HbA1c Change From Baseline at Week 18 (Interim Analysis) | Baseline and week 18 | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule. | percent | MEAN |
| PRIMARY | HbA1c Change From Baseline at Week 18 (Final Analysis) | Baseline and week 18 | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule. | percent | MEAN |
| SECONDARY | Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | Baseline and week 18 | All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis). | mg/dl | MEAN |
| SECONDARY | Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) | Week 18 | Full Analysis Set (FAS) patients with baseline HbA1c \>= 7.0%. Patients without a value at week 18 were analysed as non-responders. | percent of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Week 18 | FAS patients with baseline HbA1c \>= 6.5%. Patients without a value at Week 18 were analysed as non-responders. | percent of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) | Week 18 | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders. | percent of patients | NUMBER |
| SECONDARY | The Change in HbA1c From Baseline by Visit Over Time | Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 | Treated set (OC) | percent | MEAN |
| SECONDARY | The Change in FPG From Baseline by Visit Over Time | Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 | Treated set (OC) | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| HbA1c Change From Baseline at Week 18 (Interim Analysis) | Placebo | 0.14 | Standard Error 0.16 | percent | |
| HbA1c Change From Baseline at Week 18 (Interim Analysis) | Linagliptin | -0.44 | Standard Error 0.14 | percent | |
| HbA1c Change From Baseline at Week 18 (Final Analysis) | Placebo | 0.21 | Standard Error 0.16 | percent | |
| HbA1c Change From Baseline at Week 18 (Final Analysis) | Linagliptin | -0.39 | Standard Error 0.14 | percent | |
| Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | Placebo | 7.2 | Standard Error 6.0 | mg/dl | |
| Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | Linagliptin | -13.3 | Standard Error 5.2 | mg/dl | |
| Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) | Placebo | 11.8 | percent of patients | ||
| Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) | Linagliptin | 23.5 | percent of patients | ||
| Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Placebo | 2.9 | percent of patients | ||
| Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Linagliptin | 8.9 | percent of patients |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Glimepiride | 76 | |
| Overall Study | STARTED | Linagliptin | 151 | |
| Overall Study | COMPLETED | Placebo/Glimepiride | 58 | |
| Overall Study | COMPLETED | Linagliptin | 119 | |
| Overall Study | NOT COMPLETED | Placebo/Glimepiride | 18 | |
| Overall Study | NOT COMPLETED | Linagliptin | 32 |
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 | Abdominal pain upper | Gastrointestinal disorders | Placebo/Glimepiride | 4 | 76 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Linagliptin | 3 | 151 | |
| other | Fatigue | General disorders | Placebo/Glimepiride | 5 | 76 | |
| other | Fatigue | General disorders | Linagliptin | 2 | 151 | |
| other | Influenza | Infections and infestations | Placebo/Glimepiride | 2 | 76 | |
| other | Influenza | Infections and infestations | Linagliptin | 8 | 151 | |
| other | Nasopharyngitis | Infections and infestations | Placebo/Glimepiride | 6 | 76 | |
| other | Nasopharyngitis | Infections and infestations | Linagliptin | 15 | 151 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo/Glimepiride | 7 | 76 | |
| other | Upper respiratory tract infection | Infections and infestations | Linagliptin | 6 | 151 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Glimepiride | ||
| Total, all-cause mortality | Linagliptin | ||
| Total, other adverse events | Placebo/Glimepiride | 40 | 76 |
| Total, other adverse events | Linagliptin | 59 | 151 |
| Total, serious adverse events | Placebo/Glimepiride | 3 | 76 |
| Total, serious adverse events | Linagliptin | 1 | 151 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Linagliptin vs Placebo/Glimepiride: 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/NCT00740051
GET https://conductscience.org/api/trials/v1/NCT00740051/results?page=2