A trial comparing sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensificatio
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002878-47-GR
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
1. Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin.
2. HbA1c = 7% at Visit 27 of NN9068-3952 trial.
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 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
Exclusion Criteria
1. Clinically significant diseases of the major organ systems.
2. Screening calcitonin = 50ng/L.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the efficacy of dose adjustment of insulin degludec/liraglutide to a maximum dose of 80 dose steps as compared to adding insulin aspart to insulin degludec/liraglutide with a maximum dose of 50 dose steps, both arms in combination with metformin, in controlling glycaemia.;Secondary Objective: To explore efficacy in terms of other measures of glycaemic control, safety and patient reported outcomes (PRO) of dosing insulin degludec/liraglutide to a maximum dose of 80 dose steps, as compared to adding insulin aspart to insulin degludec/liraglutide, both arms in combination with metformin, in controlling glycaemia.;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from baseline in body weight<br>2. Number of treatment-emergent confirmed hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment<br>2. During 26 weeks of treatment