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

Conditions: Diabetes Mellitus Type 2
MedDRA version: 15.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-004665-32-IT

Lead Sponsor: OVO NORDISK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

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);

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia;Secondary Objective: To assess other efficacy parameters, safety and patient reported outcomes (PROs) of IDeg compared to placebo, both in combination with liraglutide and metformin;Primary end point(s): Change from baseline to 26 weeks of randomised treatment in HbA1c (%);Timepoint(s) of evaluation of this end point: After 26 weeks of randomised treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key Secondary efficacy endpoints:<br><br>-Change from baseline in FPG;<br>-Number of responders for HbA1c (< 7.0 %);<br>-Change from baseline in mean pre-breakfast measurements used for titration;<br>-Change from baseline in 8-point profile;<br>-Change from baseline in mean of the 8-point profile;<br><br>Key Secondary safety endpoints:<br><br>-Number of hypoglycaemic episodes;<br>-Number of adverse events;<br>-Changes from baseline in patient reported healt-related quality of life (PRO);;Timepoint(s) of evaluation of this end point: After 26 weeks of randomised treatment