Type 2 diabetes mellitus MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: NN1250
Product Code: NN1250
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin degludec
Current Sponsor code: NNC 0100-000-0454
Concentration unit: U/ml unit(s)/mil
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To compare the efficacy and safety of the two different titration algorithms after 26 weeks of treatment in terms of: - Other parameters for glycaemic control - Safety • To describe subject satisfaction with the investigational pen PDS290.;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%.;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory). | — |
Countries
Finland, Germany, Spain
Outcome results
None listed