Trial · NCT01183013
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
NCT01183013, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks. Trials, record NCT01183013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183013
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
- NCT number
- NCT01183013
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 936 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
Pioglitazone 15 mg, Pioglitazone 45 mg, Pioglitazone 30 mg, Linagliptin 5mg / Pioglitazone 45 mg FDC, Linagliptin 5mg / Pioglitazone 30 mg FDC, Linagliptin 5mg, Linagliptin 5mg / Pioglitazone 15 mg FDC
- First posted
- 2010-08-17
- Last updated
- 2014-10-20
- Other registries' IDs
- eudract:2008-008127-15
- Results first posted
- 2014-04-21
- Limitations and caveats
- The study (Part B treatment only) was stopped early by protocol amendment #5, although Part A (time frame for all efficacy outcomes) proceeded to completion
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c After 30 Weeks of Treatment. | Baseline and 30 weeks | HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c. |
| Secondary | Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment | Baseline and 30 weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin. |
| Secondary | Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment | Baseline and 30 weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin. |
| Secondary | Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment) | Baseline and 30 weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin. |
| Secondary | HbA1c Change From Baseline by Visit Over Time | Baseline, week 6, week 12, week 18, week 24, week 30 | HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction. |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment | Baseline and 30 weeks | The change from baseline is the FPG after 30 weeks minus the baseline FPG. |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time | Baseline, week 6, week 12, week 18, week 24, week 30 | The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction |
| Secondary | Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT) | Baseline and 30 weeks | The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG. |
| Secondary | Time to First Use of Rescue Therapy | 30 weeks | Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis. |
| Secondary | Incidence of Rescue Therapy During the First 30 Weeks of Treatment | 30 weeks | Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment. |
Source ClinicalTrials.gov
Outcomes10
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 After 30 Weeks of Treatment. | Baseline and 30 weeks | Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c. | percent | MEAN |
| SECONDARY | Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment | Baseline and 30 weeks | FAS patients who also had baseline HbA1c\>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF). | participants | NUMBER |
| SECONDARY | Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment | Baseline and 30 weeks | FAS patients who also had baseline HbA1c \>=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF) | participants | NUMBER |
| SECONDARY | Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment) | Baseline and 30 weeks | FAS with non-completers (without a value at Week 30) considered as failure | participants | NUMBER |
| SECONDARY | HbA1c Change From Baseline by Visit Over Time | Baseline, week 6, week 12, week 18, week 24, week 30 | FAS (observed cases) | percent | MEAN |
| SECONDARY | Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment | Baseline and 30 weeks | Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30. | mg/dL | MEAN |
| SECONDARY | Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time | Baseline, week 6, week 12, week 18, week 24, week 30 | FAS (observed cases) | mg/dL | MEAN |
| SECONDARY | Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT) | Baseline and 30 weeks | MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Use of Rescue Therapy | 30 weeks | FAS | Proportion of participants | NUMBER |
| SECONDARY | Incidence of Rescue Therapy During the First 30 Weeks of Treatment | 30 weeks | FAS | participants | NUMBER |
Source ClinicalTrials.gov
Results by group133
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 After 30 Weeks of Treatment. | Pio15 | -0.66 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Pio30 | -0.69 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Pio45 | -0.87 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Lina5 | -0.39 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Lina5Pio15 | -0.83 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Lina5Pio30 | -1.06 | Standard Error 0.09 | percent | |
| Change From Baseline in HbA1c After 30 Weeks of Treatment. | Lina5Pio45 | -1.28 | Standard Error 0.09 | percent | |
| Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment | Pio15 | 39 | participants | ||
| Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment | Pio30 | 55 | participants | ||
| Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment | Pio45 | 68 | participants |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pio15/Pio30 | 131 | |
| Overall Study | STARTED | Pio30/Pio30 | 140 | |
| Overall Study | STARTED | Pio45/Pio45 | 138 | |
| Overall Study | STARTED | Lina5/Lina5 | 135 | |
| Overall Study | STARTED | Lina5Pio15/Lina5Pio30 | 126 | |
| Overall Study | STARTED | Lina5Pio30/Lina5Pio30 | 133 | |
| Overall Study | STARTED | Lina5Pio45/Lina5Pio45 | 133 | |
| Overall Study | COMPLETED | Pio15/Pio30 | 86 | |
| Overall Study | COMPLETED | Pio30/Pio30 | 101 | |
| Overall Study | COMPLETED | Pio45/Pio45 | 97 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events686
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 | Pio15/Pio30 | 2 | 131 | |
| other | Diarrhoea | Gastrointestinal disorders | Pio30/Pio30 | 0 | 140 | |
| other | Diarrhoea | Gastrointestinal disorders | Pio45/Pio45 | 5 | 138 | |
| other | Diarrhoea | Gastrointestinal disorders | Lina5/Lina5 | 7 | 135 | |
| other | Diarrhoea | Gastrointestinal disorders | Lina5Pio15/Lina5Pio30 | 10 | 126 | |
| other | Diarrhoea | Gastrointestinal disorders | Lina5Pio30/Lina5Pio30 | 2 | 133 | |
| other | Diarrhoea | Gastrointestinal disorders | Lina5Pio45/Lina5Pio45 | 3 | 133 | |
| other | Oedema | General disorders | Pio15/Pio30 | 4 | 131 | |
| other | Oedema | General disorders | Pio30/Pio30 | 1 | 140 | |
| other | Oedema | General disorders | Pio45/Pio45 | 7 | 138 |
1 to 10 of 686Source ClinicalTrials.gov
See all 686 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pio15/Pio30 | ||
| Total, all-cause mortality | Pio30/Pio30 | ||
| Total, all-cause mortality | Pio45/Pio45 | ||
| Total, all-cause mortality | Lina5/Lina5 | ||
| Total, all-cause mortality | Lina5Pio15/Lina5Pio30 | ||
| Total, all-cause mortality | Lina5Pio30/Lina5Pio30 | ||
| Total, all-cause mortality | Lina5Pio45/Lina5Pio45 | ||
| Total, other adverse events | Pio15/Pio30 | 57 | 131 |
| Total, other adverse events | Pio30/Pio30 | 55 | 140 |
| Total, other adverse events | Pio45/Pio45 | 66 | 138 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 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/NCT01183013
GET https://conductscience.org/api/trials/v1/NCT01183013/results?page=2