Status:
COMPLETED
Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 ye...
Eligibility Criteria
Inclusion
- 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
- Further inclusion criteria apply
Exclusion
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03429543
Start Date
March 20 2018
End Date
May 31 2023
Last Update
February 23 2024
Active Locations (83)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
University of Arizona
Tucson, Arizona, United States, 85724
3
CHOC Children's Hospital
Orange, California, United States, 92868
4
Stanford University Medical Center
Palo Alto, California, United States, 94304