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: 14.1Level: 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-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-04
• Last Update Posted: 30 June 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

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 PROs of IDeg compared to placebo, both in combination with liraglutide and metformin;Primary end point(s): Change from baseline 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>1. Change from baseline in FPG<br>2. Number of responders for HbA1c (< 7.0 %) <br>3. Change from baseline in mean pre-breakfast measurements used for titration<br>4. Change from baseline in 8-point profile<br>5. Change from baseline in mean of the 8-point profile<br><br>Key secondary safety endpoints<br>6. Number of hypoglycaemic episodes<br>7. Number of adverse events <br><br>Key secondary PRO endpoint<br>8. Change from baseline in patient reported health-related quality of life;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints<br>1.-5. after 26 weeks of randomised treatment<br><br>Key secondary safety endpoints<br>6.-7. during 26 weeks of randomised treatment<br><br>Key secondary PRO endpoint<br>8. after 26 weeks of randomised treatment using the Short-Form 36 Health Survey version 2 (SF-36®v2)