A trial comparing the efficacy and safety of insulin degludec once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different titration algorithms - BEGIN™: ONCE SIMPLE USE

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-022337-29-FI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• Male and female = 18 years
• 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) all 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

Exclusion Criteria

• 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
Main Objective: To confirm the efficacy of the insulin degludec 100 U/mL (IDeg) once daily (OD) simple titration algorithm + metformin in controlling glycaemia with respect to change from baseline glycosylated haemoglobin (HbA1c) after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks of treatment between IDeg OD using the simple algorithm + metformin and IDeg OD using the step wise algorithm + metformin, to a noninferiority limit of 0.4%.;Secondary Objective: • To compare the efficacy and safety of the two different titration algorithms after 26 weeks of treatment in terms of:<br>- Other parameters for glycaemic control<br>- Safety<br>• To describe subject satisfaction with the investigational pen PDS290.;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory).