Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: insulin degludec
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
Enrollment
222 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
- 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, alpha-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
- BMI (Body Mass Index) no higher than 45.0 kg/m^2
Exclusion criteria
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
- Suffer from a life threatening disease (e.g. cancer)
- Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
222 participants in 2 patient groups
IDeg Simple
Experimental group
Treatment:
Drug: insulin degludec
Drug: insulin degludec
IDeg Step wise
Experimental group
Treatment:
Drug: insulin degludec
Drug: insulin degludec
Trial contacts and locations
45
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Data sourced from clinicaltrials.gov
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