A trial comparing the efficacy and safety of insulin degludec three times weekly in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different titration algorithms - BEGIN™: EASY USE
- Conditions
- Type 2 DiabetesMedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2010-022304-50-HU
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 218
• Male or female >= 18 years of age
• Type 2 diabetes (diagnosed clinically) for >= 24 weeks prior to randomisation (Visit 2)
• Insulin naïve subjects (Allowed are: Previous short term insulin treatment = 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods > 14 days in total).
• Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP IV) inhibitors, a glucosidase inhibitors, thiazolidinediones (TZDs) with unchanged dosing for at least 12 weeks prior to randomisation (visit 2)
- metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
• HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
• Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to visit 2
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator
• Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period.
• Known or suspected hypersensitivity to trial products or related products
• The receipt of any investigational drug within 4 weeks prior to visit 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method