Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin NPH
Intervention description: Treat-to-target, s.c. (under the skin) injection, once daily; Treat-to-target, s.c. (under the skin) injection, once daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once
      daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with
      type 2 diabetes naive to previous insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Insulin naive

          -  Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving
             therapeutic targets

          -  HbA1c between 8% - 10.5%

        Exclusion Criteria:

          -  Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)

          -  Previous treatment with insulin (except for short-term treatment with insulin for
             intercurrent illness as judged by the Investigator)

          -  Proliferative retinopathy, maculopathy requiring treatment,

          -  Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia

          -  End stage liver disease (increased liver enzymes 4 fold), end stage renal disease
             assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or
             dialysed patient, acute heart failure, any acute cardiovascular event or
             cerebrovascular event less than 6 months

          -  Acute disease with poor prognosis

          -  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

          -  Mental incapacity, unwillingness or language barrier precluding adequate understanding
             or co-operation (patients having a score of less than 15 in a previous MMSE
             (Mini-Mental State Examination) in the last six months) and any conditions as judged
             by the investigator

          -  Legal incapacity or limited legal capacity (patients under guardianship or
             curatorship)

          -  Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique
             treatment)

          -  Participation in another clinical trial less than one month before inclusion in this
             trial

          -  Illness requiring repeated hospitalisation

          -  Known or suspected allergy to the insulin or any compositional component

          -  Anticipated change or new use in concomitant medication known to interfere with
             glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)

          -  Any other condition that the Investigator feels would interfere with trial
             participation or evaluation of results

          -  Terminal illness