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

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 (HbA1c ≥ 6.5% and ≤ 10.5%) as measured by the central
laboratory at Visit 1A

- 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.

- 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

Exclusion Criteria:

- Positive for islet cell antigen auto-antibodies (IA-2) and glutamic acid decarboxylase
(GADA) auto antibodies as measured by the central laboratory at Visit 1A

- Any history of ketoacidosis within 8 weeks prior to Visit 1A

- 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