EUCTR2011-004665-32-GBActive, not recruitingNot Applicable
The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 320
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
Investigators
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