Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015255-25 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 stable treatment in elderly patients with T2DM with insufficient glycaemic control
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin | Experimental | patients receive linagliptin 5 mg tablets once daily |
|
| placebo | Placebo Comparator | patients receive placebo tablets matching linagliptin 5 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin | Drug | patients receive linagliptin 5 mg tablets once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline to 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 prior use of insulin. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline to 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 prior use of insulin. | Baseline and week 6 |
| HbA1c Change From Baseline to Week 12 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.63.61005 Boehringer Ingelheim Investigational Site | Gosford | New South Wales | Australia | |||
| 1218.63.61006 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25236917 | Derived | Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16. | |
| 24169807 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 241 patients were randomised in a 2:1 ratio to receive treatment with linagliptin 5mg (n=162) or placebo (n=79). All randomised patients were treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| FG001 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
patients receive placebo matching linagliptin 5 mg once daily |
|
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 prior use of insulin. |
| Baseline and week 12 |
| HbA1c Change From Baseline to 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 prior use of insulin. | Baseline and week 18 |
| FPG Change From Baseline to 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 prior use of insulin. | Baseline and week 24 |
| FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | Baseline and week 6 |
| FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | Baseline and week 12 |
| FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | Baseline and week 18 |
| Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% 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 above 7%. Only patients with baseline HbA1c >= 7% | Baseline and week 24 |
| Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. | Baseline and week 24 |
| Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24 | The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline 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 reduction less than 0.5% | Baseline and week 24 |
| Number of Patients With Rescue Therapy | The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial | week 24 |
| Herston |
| Queensland |
| Australia |
| 1218.63.61003 Boehringer Ingelheim Investigational Site | Adelaide | South Australia | Australia |
| 1218.63.61002 Boehringer Ingelheim Investigational Site | Daw Park | South Australia | Australia |
| 1218.63.61007 Boehringer Ingelheim Investigational Site | East Ringwood | Victoria | Australia |
| 1218.63.61001 Boehringer Ingelheim Investigational Site | Parkville | Victoria | Australia |
| 1218.63.61004 Boehringer Ingelheim Investigational Site | Reservoir | Victoria | Australia |
| 1218.63.10008 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1218.63.10003 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1218.63.10005 Boehringer Ingelheim Investigational Site | Hawkesbury | Ontario | Canada |
| 1218.63.10007 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1218.63.10006 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.63.10001 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1218.63.10002 Boehringer Ingelheim Investigational Site | Saint Romuald | Quebec | Canada |
| 1218.63.10004 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1218.63.45007 Boehringer Ingelheim Investigational Site | Aalborg | Denmark |
| 1218.63.45002 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark |
| 1218.63.45003 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark |
| 1218.63.45001 Boehringer Ingelheim Investigational Site | Birkerød | Denmark |
| 1218.63.45008 Boehringer Ingelheim Investigational Site | Hellerup | Denmark |
| 1218.63.45006 Boehringer Ingelheim Investigational Site | Hillerød | Denmark |
| 1218.63.45004 Boehringer Ingelheim Investigational Site | Hvidovre | Denmark |
| 1218.63.45005 Bispebjerg Hospital | København NV | Denmark |
| 1218.63.31008 Boehringer Ingelheim Investigational Site | Beek en Donk | Netherlands |
| 1218.63.31007 Boehringer Ingelheim Investigational Site | Beerzerveld | Netherlands |
| 1218.63.31012 Boehringer Ingelheim Investigational Site | Doetinchem | Netherlands |
| 1218.63.31014 Boehringer Ingelheim Investigational Site | Etten-Leur | Netherlands |
| 1218.63.31009 Boehringer Ingelheim Investigational Site | Oude Pekela | Netherlands |
| 1218.63.31001 Boehringer Ingelheim Investigational Site | Tubbergen | Netherlands |
| 1218.63.46004 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1218.63.46003 Boehringer Ingelheim Investigational Site | Järfälla | Sweden |
| 1218.63.46001 Boehringer Ingelheim Investigational Site | Malmö | Sweden |
| 1218.63.46002 Boehringer Ingelheim Investigational Site | Sundsvall | Sweden |
| 1218.63.46005 Boehringer Ingelheim Investigational Site | Uppsala | Sweden |
| McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29. |
| 23948125 | Derived | Barnett AH, Huisman H, Jones R, von Eynatten M, Patel S, Woerle HJ. Linagliptin for patients aged 70 years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1413-23. doi: 10.1016/S0140-6736(13)61500-7. Epub 2013 Aug 13. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| BG001 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) continuous | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Glycosylated Hemoglobin A1 (HbA1c) | Based upon the full analysis set (FAS) with 78 and 160 patients | Mean | Standard Deviation | Percent |
| ||||||||||||||
| Fasting Plasma Glucose (FPG) | Based upon the FAS with 78 and 160 patients | Mean | Standard Deviation | mg/dL |
|
| 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 | HbA1c Change From Baseline to 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 prior use of insulin. | FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline to 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 prior use of insulin. | FAS (LOCF) | Posted | Mean | Standard Error | Percent | Baseline and week 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline to 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 prior use of insulin. | FAS (LOCF) | Posted | Mean | Standard Error | Percent | Baseline and week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline to 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 prior use of insulin. | FAS (LOCF) | Posted | Mean | Standard Error | Percent | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline to 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 prior use of insulin. | FAS (LOCF) | Posted | Mean | Standard Error | mg/dL | Baseline and week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | FAS Observed cases (OC) | Posted | Mean | Standard Error | mg/dL | Baseline and week 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | FAS (OC) | Posted | Mean | Standard Error | mg/dL | Baseline and week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | FAS (OC) | Posted | Mean | Standard Error | mg/dL | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% 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 above 7%. Only patients with baseline HbA1c >= 7% | FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF) | Posted | Number | percentage of patients | Baseline and week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. | FAS (NCF) | Posted | Number | percentage of patients | Baseline and week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24 | The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline 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 reduction less than 0.5% | FAS (NCF) | Posted | Number | percentage of patients | Baseline and week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Rescue Therapy | The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial | FAS (OC) | Posted | Number | Number of patients | week 24 |
|
|
24 weeks + 7 days of follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients randomized to receive treatment with matching placebo | 5 | 79 | 37 | 79 | ||
| EG001 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5mg | 14 | 162 | 70 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|