DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy

Phase 1

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-003621-18-GR

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

- Male or female, age =18 years at the time of signing informed consent
- Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening
- HbA1c 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
- Current treatment with IGlar for at least 90 calendar days prior to screening
- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of ± 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
- Stable daily dose of metformin (=1500 mg or max. tolerated dose) for at least 90 calendar days prior to screening
- Body mass index (BMI) = 40 kg/m^2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
- Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
- Impaired liver function, defined as alanine aminotransferase (ALT) =2.5 times upper limit of normal
- Renal impairment eGFR <60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Screening calcitonin =50 ng/L
- History of pancreatitis (acute or chronic)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2