| Eligibility |
Inclusion Criteria:
- Signed written informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial
- Adult participants with T2DM
- Participants who have been treated with a an MDI regimen comprising of at least 3
doses of prandial insulin per day and one dose of basal insulin per day for at least 3
months before the screening visit,
- Participants treated with metformin (unless intolerance to metformin use is present) ±
SGLT2i at stable doses for at least 3 months prior screening.
- Total daily insulin dose = 0.8 IU/kg,
- Fasting C peptide above the lower limit of the normal range,
- HbA1c at screening visit = 75 mmol/mol (9%) as measured by local laboratory,
- HbA1c at screening visit 76-86 mmol/mol (9.1-10%) as measured by local laboratory in
case of proven non-compliance with MDI regimen
Exclusion Criteria:
- At screening visit, age under legal age of adulthood (<18 years),
- History of other diabetes than T2DM (type 1 diabetes T1DM, monogenic, secondary..)
- Use of any oral or injectable glucose-lowering agents other than those stated in the
inclusion criteria within the last 3 months before screening,
- History of discontinuation of a previous treatment with GLP-1 RA for
safety/tolerability reasons or lack of efficacy,
- Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total
duration of 1 week or more within 3 months prior to screening visit,
- Comorbidity (such as but not limited to rheumatoid arthritis) with continuous,
intermittent or expected systemic glucocorticoid therapy during the next 30 weeks
after screening visit,
- Use of weight loss drugs within 3 months prior to screening visit,
- Use of any investigational drug within 1 month or 5 half-lives, whichever is longer,
prior to screening visit,
- Within the last 3 months prior to screening visit: history of stroke, pulmonary
embolism, myocardial infarction, unstable angina, or heart failure requiring
hospitalization,
- Chronic hear failure NYHA stages III-IV
- Acute or chronic liver failure - established diagnosis of acute or chronic liver
failure (Child-Pugh 3, MELD=15) or liver cirrhosis
- Planned coronary, carotid or peripheral artery revascularisation procedures to be
performed during the study period,
- Known history of drug or alcohol abuse within 6 months prior to the time of screening
visit,
- Active malignancy
- Anaemia with haemoglobin < 100 g/l at baseline
- Participants with conditions/concomitant diseases making them non evaluable for the
efficacy endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or
plasma products within the last 3 months prior to the screening visit),
- Participants with conditions/concomitant diseases precluding their safe participation
in this study (eg, active malignant tumor, major systemic diseases, presence of
clinically significant diabetic retinopathy or presence of macular edema likely to
require treatment within the study period, etc.),
- Impossibility to meet specific protocol requirements (eg, scheduled visits,
participants unable to fully understand participant's study documents and to complete
them, etc.),
- Uncooperative or any condition that could make the participant potentially
non-compliant to the study procedures (eg, participant unable or unwilling to do
self-injections or blood glucose monitoring using the sponsor-provided blood glucose
meter at home, etc.);
- Participant is the Investigator or any Sub-Investigator, research assistant,
pharmacist, study coordinator, other staff or relative thereof directly involved in
the conduct of the protocol
- Participation in another clinical trial
- Pregnancy or lactation,
- Women of childbearing potential not protected by highly effective contraceptive method
of birth control (definition see section 10.1.1.1),
- Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie,
worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal
reflux disease requiring medical treatment, within 6 months prior to the time of
screening visit or history of surgery affecting gastric emptying
- History of pancreatitis (unless pancreatitis was related to gallstones and
cholecystectomy had now been performed), pancreatitis during previous treatment with
incretin therapies, chronic pancreatitis, pancreatectomy,
- Personal or immediate family history of MTC or genetic condition that predisposes to
MTC (eg, multiple endocrine neoplasia syndromes),
- Participant who has a renal function impairment with creatinine clearance <30 mL/min
(using the eGFR) or end-stage renal disease (ie. CKD stage IV or V),
- History of allergic reaction to any GLP-1 RA in the past
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