Type 2 Diabetes MedDRA version: 7.0 Level: PT Classification code 10012613
Conditions
Sponsors
Novo Nordisk Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) Subjects with type 2 diabetes of at least 12 months duration who are insulin naïve. Short term insulin treatment (7 days or less at any one time) is allowed. 3) OAD treatment for at least 4 months with metformin and a sulphonylurea. Subjects treated only with metformin or a sulphonylurea are also eligible if they have shown previous intolerance to sulphonylurea or metformin respectively. 4) The individual OAD dose(s) prior to inclusion must be either highest tolerated dose or at least half maximum recommended dose according to the local labelling for the OAD in question for the last 4 months before inclusion. 5) The OAD dose(s) should be unchanged for the last 4 weeks prior to inclusion. 6) Males and females, age =18 years. 7) Body mass index = 40.0 kg/m2. 8) 7.0 % = HbA1c = 10.0% at screening and based on analysis from the central laboratory. 9) Able and willing to use insulin injections for the entire trial period. 10) Able and willing to perform self-monitoring of plasma glucose. 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.Type 2 diabetic subjects currently receiving or having previously received insulin for more than 7 days at any one time. 2.Current or previous treatment with thiazolidinediones within the last 6 months. 3.Current or previous treatment with an alpha-glucosidase inhibitor, repaglinide or nateglinide within the past 30 days. 4.OAD treatment with three or more OADs within the last 6 months. 5.Diabetes other than Type 2 diabetes mellitus. 6.Known sight-threatening retinopathy as judged by the investigator. 7.Plasma creatinine =130 µmol/l. 8.Cardiac disease defined as: •Unstable angina pectoris within the last 6 months •Myocardial infarction (MI) within last 6 months •Congestive heart failure NYHA class III and IV 9Evidence of hepatic disease as determined by ALT values =2 x upper limit of normal. 10.Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator. 11.Anticipated change in dose of concomitant medication, which may interfere with glucose regulation, such as monoamine oxidase inhibitors (MAOI), beta-adrenergic agents, anabolic steroids or systemic glucocorticoids. 12.Uncontrolled hypertension measured as systolic blood pressure = 180 mmHg and / or diastolic pressure = 105 mmHg. 13.Known or suspected allergy to trial products or related products. 14.Any condition that the Investigator and / or the Sponsor feel would interfere with trial participation or the evaluation of results. 15.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation. 16.Pregnant or planning to become pregnant within the next 12 months, breast-feeding, or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods. 17.Receipt of any investigational trial drug within 3 months prior to participation in this trial. 18.Subjects previously screened for participation or having already participated in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Over 12 months: to compare the ability of three different single insulin formulation regimens to achieve good glycaemic control, defined as HbA1C levels =6.5 %, when added to current oral anti-diabetic drug (OAD) treatment in subjects with inadequately controlled type 2 diabetes. ;Secondary Objective: Over 12 to 36 months: to determine the efficacy and durability of the three different insulin regimens in the longer term and to assess the need for the addition of a second insulin formulation to achieve good glycaemic control. To derive an algorithm to estimate individual starting insulin dose requirements and insulin adjustment scales in populations such as this. ;Primary end point(s): The primary efficacy endpoint HbA1c after 12 months and 36 months | — |
Countries
Ireland
Outcome results
None listed