EUCTR2011-004665-32-ITActive, not recruitingNot Applicable
The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification.
OVO NORDISK0 sites320 target enrollmentStarted: September 3, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- 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
- •1. > or = 18 years of age;
- •2. Type 2 diabetes;
- •3. Insulin naïve;
- •4. Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU) or DPP-IV inhibitors or exenatide (only BID);
- •5. HbA1c as assessed by central laboratory:
- •- 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: 0
- •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
- •-Calcitonin > or = 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 prior to Visit 1;
- •-Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma);
Investigators
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