Patients with type 2 diabetes. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Paediatric patients, aged 10 to 17 years at the time of screening (i.e. Visit 1A) Documented diagnosis of type 2 diabetes mellitus at least 3 months prior to randomisation (i.e. Visit 2) Insufficient glycaemic control (i.e. an HbA1c > 7.0% and = 10.0%) at screening despite treatment with diet and exercise alone Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies at Visit 2 C-peptide levels (serum) = 1.5 ng/ml (at 90 min following a Boost challenge) at Visit 2 Compliance during the open-label placebo run-in period between 75% and 125%. Written informed consent provided by the patient’s parent(s) (or legal guardian) and assent by the patient at the latest by the date of Visit 1A in accordance with GCP and local legislation. Informed assent will be sought according to the patient’s age, level of maturity, competence and capacity. All informed consent/assent forms will be consistent with ICH-GCP and local IEC/IRB requirements. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months of screening Current insulin therapy, or having received insulin for > 4 weeks within the 3 months prior to randomisation Treatment with weight reduction medications (including anti-obesity treatments) within 3 months prior to randomisation Chronic treatment – treatment duration of more than two weeks - with medication known to affect glucose metabolism within 3 months prior to randomisation Anticipated need for treatment with PGP (P-glycoprotein) and CYP 3A4 inhibitors or inducers during the study. Clinically significant renal disease (defined as estimated Glomerular Filtration Rate [eGFR] 12 or who reached menarche before this age: haemoglobin of 12: haemoglobin of < 13 g/dl and haematocrit < 39% Active alcohol or drug abuse within the 3 months prior to informed consent Patients whose parent(s) (or legal guardian) will be unable to support the reporting of adverse event information Patients whose home circumstances will mean they are unable to store the study rescue medication (insulin) appropriately Known hypersensitivity or allergy to the investigational product or its excipients or placebo Participation in another trial with an investigational drug within 2 months prior to informed consent Patients considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study medication administration Any disease or clinically significant abnormality/clinical condition that may increase the risk associated with study participation or affect the study outcome, and in the judgement of the Investigator would make the patient inappropriate for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to identify the dose of linagliptin (BI1356) in paediatric patients.;Secondary Objective: Other efficacy objectives include the comparison of the lowering effect of linagliptin 1mg, 5mg and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. The study will also investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population. ;Primary end point(s): The primary endpoint in this trial is the change from baseline in HbA1c (%) after 12 weeks of treatment. Throughout the trial protocol, the term "baseline" refers to the last observation prior to the administration of any randomised study medication. | — |
Countries
France, Italy, Poland
Outcome results
None listed