Last updated on February 2020

Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM | Diabetes Mellitus Type 2 | Type 2 | Diabetes Mellitus
  • Age: Between 10 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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 for at least 12 weeks 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 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. Patients treated with diet and exercise only and 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) are also eligible in this trial.
  • DINAMOTM Mono: Drug-nave patients or patients not on active treatment (including a metformin washout for at least 12 weeks prior to Visit 2)
  • 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
  • Further inclusion criteria apply

Exclusion Criteria:

  • 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/1.73m (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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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