Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Boehringer Ingelheim
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: February 4, 2015
Last verified: February 2015
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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 Endpoint Classification: Safety/Efficacy Study 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:
- The primary efficacy endpoint in this trial is the change from baseline in Glycosylated Haemoglobin (HbA1c) (%) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The key secondary endpoint in this trial is DPP-4 inhibition (%) at trough at steady state [ Time Frame: 4 weeks or 8 weeks or 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 117 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (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 |
| Genders Eligible for Study: | Both |
| 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
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342484
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Hide Study Locations
Locations
| United States, Illinois | |
| 1218.56.01003 Boehringer Ingelheim Investigational Site | Recruiting |
| Park Ridge, Illinois, United States | |
| United States, Ohio | |
| 1218.56.01005 Boehringer Ingelheim Investigational Site | Recruiting |
| Akron, Ohio, United States | |
| United States, Texas | |
| 1218.56.01006 Boehringer Ingelheim Investigational Site | Recruiting |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| 1218.56.01004 Boehringer Ingelheim Investigational Site | Recruiting |
| Norfolk, Virginia, United States | |
| Australia, Western Australia | |
| 1218.56.61001 Boehringer Ingelheim Investigational Site | Recruiting |
| Subiaco, Western Australia, Australia | |
| Canada, Quebec | |
| 1218.56.11001 Boehringer Ingelheim Investigational Site | Recruiting |
| Montreal, Quebec, Canada | |
| France | |
| 1218.56.33003 Boehringer Ingelheim Investigational Site | Recruiting |
| Fort de France cedex, France | |
| 1218.56.33002 Boehringer Ingelheim Investigational Site | Recruiting |
| Lille, France | |
| 1218.56.33005 Boehringer Ingelheim Investigational Site | Recruiting |
| Reims, France | |
| 1218.56.33006 Boehringer Ingelheim Investigational Site | Recruiting |
| Rouen, France | |
| 1218.56.33008 Boehringer Ingelheim Investigational Site | Recruiting |
| Saint Denis Cedex, France | |
| 1218.56.33009 Boehringer Ingelheim Investigational Site | Recruiting |
| SAINT PIERRE Cedex, France | |
| Guatemala | |
| 1218.56.50202 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Guatemala, Guatemala | |
| 1218.56.50203 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Guatemala, Guatemala | |
| 1218.56.50204 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Zacapa, Guatemala | |
| Italy | |
| 1218.56.39001 Boehringer Ingelheim Investigational Site | Recruiting |
| Chieti, Italy | |
| 1218.56.39005 Boehringer Ingelheim Investigational Site | Recruiting |
| Firenze, Italy | |
| 1218.56.39006 Boehringer Ingelheim Investigational Site | Recruiting |
| Messina, Italy | |
| 1218.56.39003 Boehringer Ingelheim Investigational Site | Recruiting |
| Napoli, Italy | |
| 1218.56.39007 Boehringer Ingelheim Investigational Site | Recruiting |
| Palermo, Italy | |
| Korea, Republic of | |
| 1218.56.82005 Boehringer Ingelheim Investigational Site | Recruiting |
| Busan, Korea, Republic of | |
| 1218.56.82001 Boehringer Ingelheim Investigational Site | Recruiting |
| Seoul, Korea, Republic of | |
| 1218.56.82002 Boehringer Ingelheim Investigational Site | Recruiting |
| Seoul, Korea, Republic of | |
| 1218.56.82003 Boehringer Ingelheim Investigational Site | Recruiting |
| Suwon, Korea, Republic of | |
| Mexico | |
| 1218.56.52008 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Chihuahua, Mexico | |
| 1218.56.52002 Boehringer Ingelheim Investigational Site | Completed |
| Guadalajara, Mexico | |
| 1218.56.52001 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| León, Mexico | |
| 1218.56.52003 Boehringer Ingelheim Investigational Site | Recruiting |
| Monterrey, Mexico | |
| 1218.56.52004 Boehringer Ingelheim Investigational Site | Recruiting |
| Oaxaca, Mexico | |
| New Zealand | |
| 1218.56.64001 Boehringer Ingelheim Investigational Site | Recruiting |
| Greenlane East Auckland NZ, New Zealand | |
| 1218.56.64002 Boehringer Ingelheim Investigational Site | Recruiting |
| Wellington South, New Zealand | |
| Poland | |
| 1218.56.48002 Boehringer Ingelheim Investigational Site | Terminated |
| Gdansk, Poland | |
| 1218.56.48001 Boehringer Ingelheim Investigational Site | Completed |
| Gliwice, Poland | |
| 1218.56.48004 Boehringer Ingelheim Investigational Site | Recruiting |
| Warszawa, Poland | |
| 1218.56.48003 Boehringer Ingelheim Investigational Site | Recruiting |
| Wroclaw, Poland | |
| Russian Federation | |
| 1218.56.70005 Boehringer Ingelheim Investigational Site | Recruiting |
| Kazan, Russian Federation | |
| 1218.56.70001 Boehringer Ingelheim Investigational Site | Recruiting |
| Moscow, Russian Federation | |
| 1218.56.70003 Boehringer Ingelheim Investigational Site | Recruiting |
| Saratov, Russian Federation | |
| 1218.56.70004 Boehringer Ingelheim Investigational Site | Recruiting |
| Ufa, Russian Federation | |
| 1218.56.70006 Boehringer Ingelheim Investigational Site | Terminated |
| Yekaterinburg, Russian Federation | |
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01342484 History of Changes |
| Other Study ID Numbers: | 1218.56, 2009-017004-91 |
| Study First Received: | April 26, 2011 |
| Last Updated: | February 4, 2015 |
| Health Authority: | Australia: Human Research Ethics Committee Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Guatemala: Ministry of Public Health and Social Assistance Italy: Ethics Committee Mexico: Federal Commission for Protection Against Health Risks New Zealand: Medsafe Poland: Registration Medicinal Product Medical Device Biocidal Product Russia: Pharmacological Committee, Ministry of Health South Korea: Ministry of Food and Drug Safety (MFDS) United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Linagliptin Dipeptidyl-Peptidase IV Inhibitors Enzyme Inhibitors |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015