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

Phase 1

• Conditions: Type 2 Diabetes; MedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus

• Registration Number: EUCTR2010-022304-50-SK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• 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

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 IDeg 200U/ml 3 times weekly (3TW) simple titration algorithm + metformin in controlling glycaemia with respect to change from baseline glycosylated haemaglobin (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 200U/ml 3TW using the simple titration algorithm + metformin and IDeg 200U/ml 3TW using the step wise titration algorithm + metformin to a non-inferiority limit of 0.4%.;Secondary Objective: • To compare the efficacy and safety of the two different titration algorithms after 26<br> weeks of treatment in terms of:<br> - Other parameters for glycaemic control<br> - Safety<br>• To describe subject satisfaction with the investigational pen PDS290.<br>;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory).