A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

Recruitment & Eligibility

Inclusion Criteria

Type 2 diabetes mellitus
Male or female equal to or above 18 years of age
HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria

Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
Screening calcitonin above or equal to 50 ng/L
Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
History of pancreatitis (acute or chronic)

Study & Design

Arm && Interventions

Group	Intervention	Description
Once weekly titration	insulin degludec/liraglutide	-
Twice weekly titration	insulin degludec/liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c	Week 0, week 32	Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes	Week 0-32	An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
HbA1c Below 7.0%	Week 0, week 32	Responders to HbA1c below 7% after 32 weeks of treatment.
HbA1c Below or Equal to 6.5%	Week 0, week 32	Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.

Recruitment & Eligibility