Type 2 Diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Levemir Innolet
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
Novo Nordisk Pharmaceutique S.A.S
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.Type 2 diabetes, 3.Subject = 75 years old, 4.Subject insulin naïve optimally treated by oral antidiabetics drugs (OAD) at maximum tolerated dose for at least 3 months and not achieving therapeutic targets 5.Patients with a medical follow up for at least 3 months 6.10.5%=HbA1c = 8.0% (local dosage within the last 6 months) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 1 diabetes, secondary diabetes, MODY (Maturity Onset Diabetes of the Young) 2.HbA1c > 10.5% 3.Previous treatment with (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator). 4.Proliferative retinopathy, maculopathy requiring treatment 5.Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia 6.End stage liver disease (Prothrombin time < 40% except anticoagulant use, increased liver enzymes 4 fold), end stage renal disease assessed by MDRD < 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months 7.Acute disease without bad prognosis (temporary exclusion) 8.History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol, 9.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation 10.Legal incapacity or limited legal capacity, 11.Participation in another clinical trial less than one month before inclusion in this trial, 12.Illness requiring repeated hospitalisation, 13.Known or suspected allergy to the insulin or any compositional component, 14.Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone) 15.Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, 16.Bad term vital prognosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to compare two -basal insulin regimens as insulin therapy initiation in ageing type 2 diabetic patients with insulin detemir versus NPH insulin given once daily in the morning. ;Secondary Objective: Secondary objectives of this trial are to compare the insulin detemir to the NPH insulin treatment regimens according to the following criteria, measured at 4 and 7 months of treatment, except for Quality of Life: •Quality of Life (To give informations about the satisfaction with the insulin treatment and about feeling of glycemia control and diabetes control. ;Primary end point(s): •Efficacy objectives at 4 months and 7 months - Glycaemic control as measured by centrally measured HbA1c - Glycaemic control as measured by mean self measurement of fasting plasma glucose (FPG), pre-lunch and pre-dinner plasma glucose - Percentage of subjects achieving HbA1c =8.0% - Percentage of subjects achieving HbA1c =8.0% without hypoglycaemia - Percentage of patients achieving mean fasting capillary glycaemia =8.8 mmol/L (160mg/d) - Within-subject variation in pre-breakfast, pre-lunch and pre-dinner capillary plasma glucose level (SMPG) during the trial - Incidence of hyperglycaemic episodes •Safety objectives - Incidence of hypoglycaemic episodes reported by the patient (all, major hypoglycaemic episodes when assistance to treat is required, minor hypoglycaemic episodes when plasma glucose is < 56 mg/dL (3.1mmol/L) and when the subject is able to deal with the episode himself or any symptom of hypoglycaemia if not confirmed by a plasma glucose measurement) during the trial (nocturnal and over the entire day), - Incidence of hypoglycaemic episodes defined as a self measured plasma glucose less than 56 mg/dL (3.1 mmol/L) - Occurrence of adverse events during the trial •Insulin doses requirements: total daily doses measured at 4 and 7 months in both groups | — |
Countries
France, United Kingdom
Outcome results
None listed