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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013289-20 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Experimental | Linagliptin tablets once daily |
|
| Placebo | Placebo Comparator | Placebo tablets once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matching linagliptin tablets once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 6 weeks |
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.61.01028 Boehringer Ingelheim Investigational Site | Escondido | California | United States | |||
| 1218.61.01014 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24824197 | Derived | Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Tablet | Placebo matching linagliptin 5 mg tablet |
| FG001 | Linagliptin 5 mg Tablet | Linagliptin 5 mg (milligrams) tablet given by mouth once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Linagliptin |
| Drug |
Linagliptin tablets once daily |
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
| baseline, 12 weeks |
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 18 weeks |
| Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks |
| Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks |
| Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24 | baseline, 24 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6 | baseline, 6 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12 | baseline, 12 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18 | baseline, 18 weeks |
| Greenbrae |
| California |
| United States |
| 1218.61.01015 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| 1218.61.01042 Boehringer Ingelheim Investigational Site | Paramount | California | United States |
| 1218.61.01046 Boehringer Ingelheim Investigational Site | Poway | California | United States |
| 1218.61.01044 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 1218.61.01009 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1218.61.01049 Boehringer Ingelheim Investigational Site | Lawrenceville | Georgia | United States |
| 1218.61.01008 Boehringer Ingelheim Investigational Site | Roswell | Georgia | United States |
| 1218.61.01040 Boehringer Ingelheim Investigational Site | Meridian | Idaho | United States |
| 1218.61.01016 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1218.61.01018 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1218.61.01048 Boehringer Ingelheim Investigational Site | Lafayette | Indiana | United States |
| 1218.61.01001 Boehringer Ingelheim Investigational Site | Auburn | Maine | United States |
| 1218.61.01043 Boehringer Ingelheim Investigational Site | Olive Branch | Mississippi | United States |
| 1218.61.01052 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States |
| 1218.61.01030 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1218.61.01007 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina | United States |
| 1218.61.01004 Boehringer Ingelheim Investigational Site | Jacksonville | North Carolina | United States |
| 1218.61.01023 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina | United States |
| 1218.61.01027 Boehringer Ingelheim Investigational Site | Perrysburg | Ohio | United States |
| 1218.61.01031 Boehringer Ingelheim Investigational Site | East Providence | Rhode Island | United States |
| 1218.61.01017 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | United States |
| 1218.61.01005 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.61.01006 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1218.61.01053 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1218.61.01003 Boehringer Ingelheim Investigational Site | Sugar Land | Texas | United States |
| 1218.61.01024 Boehringer Ingelheim Investigational Site | Bennington | Vermont | United States |
| 1218.61.01020 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States |
| 1218.61.3301A Boehringer Ingelheim Investigational Site | Besançon | France |
| 1218.61.3306A Boehringer Ingelheim Investigational Site | Béziers | France |
| 1218.61.3311A Boehringer Ingelheim Investigational Site | Béziers | France |
| 1218.61.3309A Boehringer Ingelheim Investigational Site | Bourg Des Cptes | France |
| 1218.61.3310A Boehringer Ingelheim Investigational Site | Cournonterral | France |
| 1218.61.3312A Boehringer Ingelheim Investigational Site | Laval | France |
| 1218.61.3313A Boehringer Ingelheim Investigational Site | Louvigné-de-Bais | France |
| 1218.61.3305A Boehringer Ingelheim Investigational Site | Paris | France |
| 1218.61.3307A Boehringer Ingelheim Investigational Site | Paris | France |
| 1218.61.91002 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.61.91003 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.61.91004 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.61.91008 Boehringer Ingelheim Investigational Site | Hyderabad | India |
| 1218.61.91009 Boehringer Ingelheim Investigational Site | Jaipur | India |
| 1218.61.91010 Boehringer Ingelheim Investigational Site | Karnataka | India |
| 1218.61.91001 Boehringer Ingelheim Investigational Site | Maharashtra | India |
| 1218.61.91006 Boehringer Ingelheim Investigational Site | Maharashtra | India |
| 1218.61.91011 Boehringer Ingelheim Investigational Site | Maharashtra | India |
| 1218.61.91005 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1218.61.91007 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1218.61.63003 Boehringer Ingelheim Investigational Site | Cebu City | Philippines |
| 1218.61.63004 Boehringer Ingelheim Investigational Site | Cebu City | Philippines |
| 1218.61.63002 Boehringer Ingelheim Investigational Site | Davao City | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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Six participants (three participants per treatment) were excluded from all analyses due to serious site non-compliance. Thus, the total participants in Baseline Measures (272) is six less than total in Participant Flow (278).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Tablet | |
| BG001 | Linagliptin 5 mg Tablet | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Weight categories | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter |
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| Body Mass Index (BMI) categories | Number | participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Waist circumference | Mean | Standard Deviation | centimeters |
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| Smoking status | Number | participants |
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| Alcohol status | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | Percentage | baseline, 24 weeks |
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| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | Percentage | baseline, 6 weeks |
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| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | Percentage | baseline, 12 weeks |
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| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | Percentage | baseline, 18 weeks |
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| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance. | Posted | Number | Participants | 24 weeks |
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| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance. | Posted | Number | Participants | 24 weeks |
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| Secondary | Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance. | Posted | Number | Participants | 24 weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24 | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | mg/dL (milligrams per deciliter) | baseline, 24 weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6 | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | mg/dL (milligrams per deciliter) | baseline, 6 weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12 | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | mg/dL (milligrams per deciliter) | baseline, 12 weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18 | Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance. | Posted | Least Squares Mean | Standard Error | mg/dL (milligrams per deciliter) | baseline, 18 weeks |
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From drug start up to drug stop (max 24 weeks)+ 7 days
For the analysis of AEs, all events with an onset after the first dose of trial medication up to a period of 7 days after the last dose of trial medication were assigned to the randomised treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Tablet | Placebo matching linagliptin 5 mg tablet | 3 | 89 | 16 | 89 | ||
| EG001 | Linagliptin 5 mg Tablet | Linagliptin 5 mg (milligrams) tablet given by mouth once daily | 4 | 183 | 31 | 183 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hepatitis E | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
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| Calculus bladder | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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During the conduct of this trial, pioglitazone was removed from the market in France due to safety issues, and this resulted in premature termination of a number of French patients.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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| 65 to 74 years |
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| >= 75 years |
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| Male |
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| > 70 to 80 kilograms |
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| > 80 to 90 kilograms |
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| > 90 kilograms |
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| >= 25 and < 30 kilograms/square meter |
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| >= 30 kilograms/square meter |
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| Ex-smoker |
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| Currently smokes |
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| Drinks - no interference with study |
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| Drinks - investigator opinion/interfere with study |
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