Trial · NCT00621140
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
NCT00621140, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control. Trials, record NCT00621140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00621140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
- NCT number
- NCT00621140
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 503 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- linagliptin, placebo
- First posted
- 2008-02-22
- Last updated
- 2014-02-17
- Other registries' IDs
- eudract:2007-002448-10
- Results first posted
- 2011-06-07
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HbA1c Change From Baseline at Week 24 | Baseline and week 24 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
| Secondary | HbA1c Change From Baseline at Week 6 | Baseline and week 6 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
| Secondary | HbA1c Change From Baseline at Week 12 | Baseline and week 12 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
| Secondary | HbA1c Change From Baseline at Week 18 | Baseline and week 18 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
| Secondary | FPG Change From Baseline at Week 24 | Baseline and week 24 | This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. |
| Secondary | FPG Change From Baseline at Week 6 | Baseline and week 6 | This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. |
| Secondary | FPG Change From Baseline at Week 12 | Baseline and week 12 | This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. |
| Secondary | FPG Change From Baseline at Week 18 | Baseline and week 18 | This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. |
| Secondary | Percentage of Patients With HbA1c <7.0% at Week 24 | Baseline and week 24 | The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c \>= 7.0%. Only patients with baseline HbA1c \>= 7% |
| Secondary | Percentage of Patients With HbA1c<7.0% at Week 24 | Baseline and week 24 | The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c \>= 7.0%. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 24 | Baseline and week 24 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change From Baseline at Week 6 | Baseline and week 6 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change From Baseline at Week 12 | Baseline and week 12 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change From Baseline at Week 18 | Baseline and week 18 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Percent | MEAN |
| SECONDARY | FPG Change From Baseline at Week 24 | Baseline and week 24 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | mg/dL | MEAN |
| SECONDARY | FPG Change From Baseline at Week 6 | Baseline and week 6 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | mg/dL | MEAN |
| SECONDARY | FPG Change From Baseline at Week 12 | Baseline and week 12 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | mg/dL | MEAN |
| SECONDARY | FPG Change From Baseline at Week 18 | Baseline and week 18 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | mg/dL | MEAN |
| SECONDARY | Percentage of Patients With HbA1c <7.0% at Week 24 | Baseline and week 24 | This population includes the FAS with baseline HbA1c \>= 7.0%. Non-completers were considered as failure imputation (NCF). | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c<7.0% at Week 24 | Baseline and week 24 | This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF). | percentage of patients | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
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 24 | Placebo | 0.25 | Standard Error 0.07 | Percent | |
| HbA1c Change From Baseline at Week 24 | Linagliptin | -0.44 | Standard Error 0.05 | Percent | |
| HbA1c Change From Baseline at Week 6 | Placebo | 0.09 | Standard Error 0.05 | Percent | |
| HbA1c Change From Baseline at Week 6 | Linagliptin | -0.37 | Standard Error 0.04 | Percent | |
| HbA1c Change From Baseline at Week 12 | Placebo | 0.16 | Standard Error 0.06 | Percent | |
| HbA1c Change From Baseline at Week 12 | Linagliptin | -0.46 | Standard Error 0.04 | Percent | |
| HbA1c Change From Baseline at Week 18 | Placebo | 0.21 | Standard Error 0.07 | Percent | |
| HbA1c Change From Baseline at Week 18 | Linagliptin | -0.45 | Standard Error 0.05 | Percent | |
| FPG Change From Baseline at Week 24 | Placebo | 14.84 | Standard Error 2.98 | mg/dL | |
| FPG Change From Baseline at Week 24 | Linagliptin | -8.47 | Standard Error 2.03 | mg/dL |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 | 167 | |
| Overall Study | STARTED | Linagliptin | 336 | |
| Overall Study | COMPLETED | Placebo | 152 | |
| Overall Study | COMPLETED | Linagliptin | 318 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Linagliptin | 18 |
Source ClinicalTrials.gov
Adverse events36
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 | Hyperglycaemia | Metabolism and nutrition disorders | Placebo | 38 | 167 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Linagliptin | 29 | 336 | |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 167 | |
| serious | Atrial fibrillation | Cardiac disorders | Linagliptin | 1 | 336 | |
| serious | Coronary artery disease | Cardiac disorders | Placebo | 1 | 167 | |
| serious | Coronary artery disease | Cardiac disorders | Linagliptin | 1 | 336 | |
| serious | Cellulitis pharyngeal | Infections and infestations | Placebo | 0 | 167 | |
| serious | Cellulitis pharyngeal | Infections and infestations | Linagliptin | 1 | 336 | |
| serious | Pneumonia | Infections and infestations | Placebo | 0 | 167 | |
| serious | Pneumonia | Infections and infestations | Linagliptin | 1 | 336 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Linagliptin | ||
| Total, other adverse events | Placebo | 38 | 167 |
| Total, other adverse events | Linagliptin | 29 | 336 |
| Total, serious adverse events | Placebo | 7 | 167 |
| Total, serious adverse events | Linagliptin | 10 | 336 |
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: 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/NCT00621140
GET https://conductscience.org/api/trials/v1/NCT00621140/results?page=2