A trial comparing efficacy and safety of NN5401 withinsulin glargine, both in combination with oralantidiabetic drugs in subjects with type 2 diabetes

Phase 1

• Conditions: type 2 diabetes mellitus; MedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-005767-34-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-06
• Study Completion: 2010-10-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Informed consent obtained before any trial-related activities. (Trial related activities are defined as any procedures that would not have been performed during standard management of the subject).
• Male or female = 18 years of age
• Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
• Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) OD, for at least 3 months
• Ongoing treatment with: metformin with or without other OADs for at least 3 months prior to randomisation
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• BMI = 40.0 kg/m²

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 insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
• Total daily insulin dose above 1 U/kg
• Treatment with glucagon-like peptide 1(GLP-1) receptor agonists within 3 months prior to visit 1
• Current rosiglitazone users
• Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
• Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke;
decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified