Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017004-91 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The main objective of this study is to identify the dose of linagliptin in paediatric patients.
Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.
Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin low dose | Experimental | linagliptin low dose for children once daily |
|
| linagliptin high dose | Experimental | linagliptin high dose for children once daily |
|
| placebo | Placebo Comparator | matching placebo for each linagliptin dose once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | comparison of different dosages of drug (low vs high) vs placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment | Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State | DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100. |
Not provided
Inclusion criteria:
Exclusion criteria:
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 |
|---|---|---|---|---|---|---|
| 1218.56.01006 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |||
| 1218.56.01004 Boehringer Ingelheim Investigational Site |
All patients suitable after screening underwent a 2-week open-label placebo run-in period before randomisation. Patients who successfully completed this period and who still met the inclusion/exclusion criteria were randomised to the 12-week randomised period in which they received either 1 of the 2 doses of linagliptin or placebo.
Randomised, double-blind, placebo-controlled parallel group dose-finding study of linagliptin over 12 weeks in children and adolescents, from 10 to 17 years of age, with type 2 diabetes mellitus. Due to serious Good clinical practice (GCP) breach, 1 patient excluded from all analyses. So protocol section has 40 subjects and participant flow has 39
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo dose was administered orally once daily for 12 weeks |
| FG001 | Linagliptin 1 mg | Linagliptin 1 mg dose was administered orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI1356 low dose |
| Drug |
comparison of different dosages of drug (low vs high) vs placebo |
|
| BI1356 high dose | Drug | comparison of different dosages of drug (low vs high) vs placebo |
|
| Baseline and 4 weeks or 8 weeks or 12 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment | Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Baseline and 12 weeks |
| Norfolk |
| Virginia |
| United States |
| 1218.56.11001 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1218.56.33003 Boehringer Ingelheim Investigational Site | Fort de France Cedex | France |
| 1218.56.33006 Boehringer Ingelheim Investigational Site | Rouen | France |
| 1218.56.50202 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 1218.56.50203 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 1218.56.39005 Boehringer Ingelheim Investigational Site | Florence | Italy |
| 1218.56.52008 Boehringer Ingelheim Investigational Site | Chihuahua City | Mexico |
| 1218.56.52002 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico |
| 1218.56.52001 Boehringer Ingelheim Investigational Site | León | Mexico |
| 1218.56.52003 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1218.56.52004 Boehringer Ingelheim Investigational Site | Oaxaca City | Mexico |
| 1218.56.48002 Boehringer Ingelheim Investigational Site | Gdansk | Poland |
| 1218.56.48001 Boehringer Ingelheim Investigational Site | Gliwice | Poland |
| 1218.56.48004 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1218.56.48003 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| 1218.56.70001 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.56.70003 Boehringer Ingelheim Investigational Site | Saratov | Russia |
| 1218.56.70004 Boehringer Ingelheim Investigational Site | Ufa | Russia |
| 1218.56.70006 Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
| 1218.56.82005 Boehringer Ingelheim Investigational Site | Busan | South Korea |
| 1218.56.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.56.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.56.82003 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| FG002 | Linagliptin 5 mg | Linagliptin 5 mg dose was administered orally once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS) including all patients who were treated with at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo dose was administered orally once daily for 12 weeks |
| BG001 | Linagliptin 1 mg | Linagliptin 1 mg dose was administered orally once daily for 12 weeks |
| BG002 | Linagliptin 5 mg | Linagliptin 5 mg dose was administered orally once daily for 12 weeks |
| BG003 | 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 |
|
| 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 Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment | Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline and 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State | DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100. | Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. OR (Original Results). The analysis excludes placebo patients and 1 FAS patient from Linagliptin 1 mg group. | Posted | Median | Inter-Quartile Range | Percentage of DPP-4 inhibition | Baseline and 4 weeks or 8 weeks or 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment | Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and 12 weeks |
|
From the first intake of study drug until 7 days after the last drug administration, up to 13 weeks.
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 | Matching placebo dose was administered orally once daily for 12 weeks | 1 | 15 | 7 | 15 | ||
| EG001 | Linagliptin 1 mg | Linagliptin 1 mg dose was administered orally once daily for 12 weeks | 0 | 10 | 8 | 10 | ||
| EG002 | Linagliptin 5 mg | Linagliptin 5 mg dose was administered orally once daily for 12 weeks | 0 | 14 | 6 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 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 |
|
| No |
| Superiority or Other |
| Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model. | Mixed Models Analysis | The Kenward-Roger approximation was used to estimate denominator degrees of freedom. | 0.1447 | Mean Difference (Net) | -0.63 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -1.50 | 0.23 | Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo. | No | Superiority or Other |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|