type 2 diabetes MedDRA version: 12.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial related activities are defined as any procedure that would not have been performed during standard management of the subject) 2. Male or female = 18 years of age 3. Type 2 diabetes mellitus (diagnosed clinically) for = 6 months 4. HbA1c 7.5-11.0% (both inclusive) by central laboratory analysis 5. BMI = 40.0 kg/m2 6. Insulin naive subject (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) 7. Ongoing treatment with: Metformin and at least one other OAD for at least 3 months prior to randomisation with the minimum doses stated: - Metformin:(including fixed combination products) 1500 mg or maximum tolerated dose (at least 1000 mg daily) - Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to approved labelling - DPP-4 inhibitor: Minimum 100 mg daily or according to approved labelling - Acarbose: minimum half of the daily maximal dose or maximum tolerated dose 8. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the protocol 9. Subject is likely to comply with the Investigator’s instruction 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: 1. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors 2. Use within the last 3 months prior to Visit 1 of GLP-1 receptor agonists and/or thiazolidinediones (TZDs) 3. Anticipated significant lifestyle change during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits 4. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty. 5. Uncontrolled treated/untreated severe hypertension (systolic blood pressure =180 mm Hg and/or diastolic blood pressure = 100 mmHg) 6. Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt or the result is permitted with the result of the last sample being conclusive) 7. Impaired renal function defined as serum-creatinine = 125 µmolor = 1.4 mg/dL for males and = 110 µmol/L or = 1.3 mg/dL for females or glomerular filtration rate below 60 mL/min, calculated by the Cockroft & Gault formula and according to local practise for metformin use (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) 8. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months 9. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator 10. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements 11. Cancer and medical history (except basal cell skin cancer or squamous cell skin cancer) 12. 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 13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write 14. 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 15. Known or suspected allergy to any of the trial products or related products 16. Receipt of any investigational drug within one month prior Visit 1 17. Donation of blood or participation in other trials within one month prior to Visit 1 18. Known or suspected abuse of alcohol, narcotics or illicit drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of SIAC OD + 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 SIAC OD + metformin and insulin glargine OD + metformin to a non-inferiory limit of 0.4%, and if non-inferiority is confirmed to a superiority limit of 0%.;Secondary Objective: To confirm superiority of SIAC OD + metformin over insulin glargine OD + metformin after 26 weeks of treatment in terms of: • Prandial plasma glucose (PG) increment at breakfast • Fluctuation in nocturnal interstitial glucose (IG) • Frequency of responders for HbA1c (<7.0%) without hypoglycaemic episodes • Nocturnal hypoglycaemic episodes • Body weight To compare efficacy and safety after 26 weeks of treatment in terms of: • Fasting plasma glucose (FPG) from central laboratory • 9-point self measured plasma glucose (SMPG) profile • Self measured plasma glucose for dose adjustments • Glucose profile as measured with CGM in a sub-population • Frequency of responders for HbA1c • Frequency of responders for HbA1c without hypoglycaemic episodes • Clinical and laboratory assessments • ß-cell function • Cardiovascular risk (CV) markers • Adverse events (AEs) • Hypoglycaemic episodes • Insulin dose • Insulin antibodies • Patient reported outcome (PRO);Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory) | — |
Countries
Austria, Spain
Outcome results
None listed