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Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01342484
First received: April 26, 2011
Last updated: July 27, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: placebo Drug: BI1356 low dose Drug: BI1356 high dose | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]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.
Secondary Outcome Measures:
- Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State [ Time Frame: Baseline and 4 weeks or 8 weeks or 12 weeks ]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.
- Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]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.
| Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Study Completion Date: | February 2016 |
| Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: linagliptin low dose
linagliptin low dose for children once daily
|
Drug: BI1356 low dose
comparison of different dosages of drug (low vs high) vs placebo
|
|
Experimental: linagliptin high dose
linagliptin high dose for children once daily
|
Drug: BI1356 high dose
comparison of different dosages of drug (low vs high) vs placebo
|
|
Placebo Comparator: placebo
matching placebo for each linagliptin dose once daily
|
Drug: placebo
comparison of different dosages of drug (low vs high) vs placebo
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
- Insufficient glycaemic control (i.e. an HbA1c > 6.5% and <= 10.5%) despite treatment with diet and exercise and/or metformin (>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be <= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
- Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
- C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge)
Exclusion criteria:
- History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
- Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
- Treatment with weight reduction medications (including anti-obesity treatments)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342484
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342484
Locations
| United States, Texas | |
| 1218.56.01006 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| 1218.56.01004 Boehringer Ingelheim Investigational Site | |
| Norfolk, Virginia, United States | |
| Canada, Quebec | |
| 1218.56.11001 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| France | |
| 1218.56.33003 Boehringer Ingelheim Investigational Site | |
| Fort de France cedex, France | |
| 1218.56.33006 Boehringer Ingelheim Investigational Site | |
| Rouen, France | |
| Guatemala | |
| 1218.56.50202 Boehringer Ingelheim Investigational Site | |
| Guatemala, Guatemala | |
| 1218.56.50203 Boehringer Ingelheim Investigational Site | |
| Guatemala, Guatemala | |
| Italy | |
| 1218.56.39005 Boehringer Ingelheim Investigational Site | |
| Firenze, Italy | |
| Korea, Republic of | |
| 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 | |
| Mexico | |
| 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 | |
| Poland | |
| 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 | |
| Russian Federation | |
| 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 | |
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01342484 History of Changes |
| Other Study ID Numbers: |
1218.56 2009-017004-91 ( EudraCT Number: EudraCT ) |
| Study First Received: | April 26, 2011 |
| Results First Received: | July 27, 2016 |
| Last Updated: | July 27, 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Linagliptin Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 22, 2017