The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensificatio

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 16.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004665-32-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-20
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- = 18 years of age
- Type 2 diabetes
- Insulin naïve
- Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only BID)
- HbA1c (by central laboratory analysis):
- 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy
- 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)
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 224
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
- Calcitonin = 50 pg/mL
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
- Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified