Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
10–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit 2)
Male and female patients
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient's legal representative information sheet.
Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with ICH-GCP and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence and capacity)
Documented diagnosis of T2DM at Visit 1A:
* DINAMO TM: Documented diagnosis of T2DM for at least 8 weeks at Visit 1A
* DINAMO TM Mono: Confirmation of T2DM at Visit 1A
Insufficient glycaemic control as measured by the central laboratory at Visit 1A:
* DINAMO TM: HbA1c ≥ 6.5% and ≤ 10.5%
* DINAMO TM Mono: HbA1c ≥ 6.5% and ≤ 9.0%
DINAMO TM: Patients treated with
* diet and exercise plus metformin at a stable dose for 8 weeks prior to Visit 2 or not tolerating metformin (defined as patients who were on metformin treatment for at least 1 week and had to discontinue metformin due to metformin-related side effects as assessed by the investigator) AND/OR
* diet and exercise plus stable basal or MDI insulin therapy,, defined as a weekly average variation of the basal insulin dose ≤ 0.1 IU/kg over 8 weeks prior to Visit 2. - DINAMOTM Mono: Drug-naïve patients or patients not on active treatment (including discontinuation of metformin due to intolerance \[or previous discontinuation for other reasons\] and/or discontinuation of insulin \[insulin use must be 8 weeks or less\] at investigator's discretion) prior to or at Visit 1A)
BMI ≥ 85th percentile for age and sex according to WHO references at Visit 1B
Non-fasting serum C-peptide levels ≥ 0.6 ng/ml as measured by the central laboratory at Visit 1A
Compliance with trial medication intake must be between 75% and 125% during the open-label placebo run-in period
You may not be if
Any history of acute metabolic decompensation such as diabetic ketoacidosis within 8 weeks prior to Visit 1A and up to randomisation (mild to moderate polyuria at the time of randomisation is acceptable)
Diagnosis of monogenic diabetes (e.g. MODY)
History of pancreatitis
Diagnosis of metabolic bone disease
Gastrointestinal disorders that might interfere with study drug absorption according to investigator assessment
Secondary obesity as part of a syndrome (e.g. Prader-Willi syndrome)
Any antidiabetic medication (with the exception of metformin and/or insulin background therapy) within 8 weeks prior to Visit 1A and until Visit 2
Treatment with weight reduction medications (including anti-obesity drugs) within 3 months prior to Visit 1A and until Visit 2
History of weight-loss surgery or current aggressive diet regimen (according to investigator assessment) at Visit 1A and until Visit 2
Treatment with systemic corticosteroids for \> 1 week within 4 weeks prior to Visit 1A and up to Visit 2 Inhaled or topical use of corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable.
Change in dose of thyroid hormones within 6 weeks prior to Visit 1A or planned change or initiation of such therapy before Visit 2
Known hypersensitivity or allergy to the investigational products or their excipients
Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m² (according to Zappitelli formula) as measured by the central laboratory at Visit 1A
Indication of liver disease defined by serum level of either alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase above 3 fold upper limit of normal (ULN) at Visit 1A as measured by the central laboratory at Visit 1A
History of belonephobia (needle phobia)
Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1A, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
Any other acute or chronic medical or psychiatric condition or laboratory abnormality that, based on investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome
Medical contraindications to metformin according to the local label (for patient on metformin background therapy)
Patient not able or cannot be supported by his/her parent(s) or legal guardian to understand and comply with study requirements based on investigator's judgement
Previous randomisation in this trial
Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
Chronic alcohol or drug abuse within 3 months prior to Visit 1A or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial
Female patients who are pregnant, nursing, or who plan to become pregnant in the trial
