Clinical Trial Details
| Trial ID: | L5118 |
| Source ID: | NCT01342484 |
| Associated Drug: | Placebo |
| Title: | Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01342484/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: placebo|DRUG: BI1356 low dose|DRUG: BI1356 high dose |
| Outcome Measures: | 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., 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., 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 |
| Sponsor/Collaborators: | Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE2 |
| Enrollment: | 40 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT |
| Start Date: | 2011-04 |
| Completion Date: | 2016-02 |
| Results First Posted: | 2016-09-15 |
| Last Update Posted: | 2016-09-15 |
| Locations: | 1218.56.01006 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.56.01004 Boehringer Ingelheim Investigational Site, 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, Guatemala|1218.56.50203 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1218.56.39005 Boehringer Ingelheim Investigational Site, Firenze, Italy|1218.56.82005 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of|1218.56.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.56.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.56.82003 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1218.56.52008 Boehringer Ingelheim Investigational Site, Chihuahua, 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, 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, Warszawa, Poland|1218.56.48003 Boehringer Ingelheim Investigational Site, Wroclaw, Poland|1218.56.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.56.70003 Boehringer Ingelheim Investigational Site, Saratov, Russian Federation|1218.56.70004 Boehringer Ingelheim Investigational Site, Ufa, Russian Federation|1218.56.70006 Boehringer Ingelheim Investigational Site, Yekaterinburg, Russian Federation |
| URL: | https://clinicaltrials.gov/show/NCT01342484 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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