Type 2 diabetes mellitus MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: IDegAsp 30 PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin degludec
CAS Number: 844439-96-9
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentrati
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) - Male or female = 18 years of age - Type 2 diabetes mellitus (diagnosed clinically) for = 24 weeks - Current treatment: metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPPIV) inhibitor, a-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling - a-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose - Insulin naïve subject; allowed is: - Previous short term insulin treatment up to 14 days - Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) - HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis - Body mass index (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 319 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: - Treatment with thiazolidinedione (TZDs) or GLP-1 receptor agonists within 12 weeks prior to Visit 1 - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors - Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits - Cardiovascular disease, within the last 24 weeks prior to visit 1, defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial - Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period - Known or suspected hypersensitivity to trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of IDegAsp twice daily (BID) added to metformin in controlling glycaemia with respect to change from baseline in 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 IDegAsp and BIAsp 30 both BID added to metformin, to a non-inferiority limit of 0.4%, and if noninferiority is confirmed, to a superiority limit of 0%.;Secondary Objective: To confirm superiority of IDegAsp BID added to metformin against BIAsp 30 BID added to metformin after 26 weeks of treatment in terms of: - Fasting plasma glucose (FPG) from central laboratory - Nocturnal hypoglycaemic episodes (severe and minor) - Hypoglycaemic episodes (severe and minor) - Body weight - Frequency of responders for HbA1c (<7.0 %) without severe or minor hypoglycaemic episodes To compare efficacy and safety of IDegAsp BID added to metformin against BIAsp 30 BID added to metformin after 26 weeks of treatment in terms of: - 9-point profile self measured plasma glucose (SMPG) - 2-point profile (SMPG) for dose adjustments - Frequency of responders for HbA1c targets - Adverse Events (AEs) - Hypoglycaemic episodes - Clinical and laboratory assessments - Insulin dose;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (central laboratory);Timepoint(s) of evaluation of this end point: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in FPG after 26 weeks of treatment (central laboratory) 2. Number of treatment emergent nocturnal (00:01-05:59 am) severe or minor hypoglycaemic episodes 3. Number of severe and minor treatment emergent hypoglycaemic episodes 4. Change from baseline in body weight after 26 weeks of treatment 5. Responder without hypoglycaemic episodes (HbA1c <7.0% at end of trial and no severe or minor hypoglycaemic episodes during the last 12 weeks of treatment including only subjects exposed for at least 12 weeks);Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment 2. On or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product 3. On or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product 4. After 26 weeks of treatment 5. After 26 weeks of treatment | — |
Countries
Algeria, Bulgaria, Croatia, Czech Republic, Germany, Poland, Romania, Slovakia, Turkey, Ukraine
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed