Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin aspart; biphasic insulin aspart 30; metformin
Intervention description: Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).; Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin); Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily; 1000-2000 mg/day in combination with insulin treatment
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa. The aim of this clinical trial is to investigate the
      effect of 50 weeks of treatment with different intensified insulin administrations (all in
      combination with a fixed dose of metformin) on blood sugar control in subjects with type 2
      diabetes inadequately controlled by oral anti-diabetic drugs (OADs).
    

Eligibility 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)

          -  Diagnosed type 2 diabetes (WHO 1999 criteria)

          -  Currently treated with suboptimal daily dose of OADs (mono or combination therapy) for
             at least 6 months

          -  Male or female age at least 18 years old

          -  HbA1c at least 7.0 % and maximum 11.0% for subjects treated with metformin
             mono-therapy, or maximum 10% for subjects treated with OAD combination therapy

          -  BMI maximum 40 kg/m^2

          -  Able and willing to perform self-monitoring of plasma glucose according to the
             protocol and to keep a diary

          -  Able and willing to be treated with up to 4 insulin injections per day

        Exclusion Criteria:

          -  Known or suspected allergy to trial product(s) or related products

          -  Previous participation in this trial. Participation is defined as randomisation

          -  Females of childbearing potential who are pregnant, breast-feeding or intend to become
             pregnant or are not using adequate contraceptive methods (adequate contraceptive
             measures as required by local law or practice)

          -  Participated in another clinical trial and received an investigational drug within the
             last weeks prior to the present trial

          -  Impaired hepatic function defined as alanine aminotransferase (ALT) or alkaline
             phosphatase (ALP) at least 2.5 times upper referenced limit

          -  Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115
             mmol/L) for males and at least 1.2 mg/dL (at least 106 mmol/L) for females

          -  Subject has a clinically significant, active (or over the past 12 months)
             cardiovascular history (including a history of myocardial infarction (MI), arrhythmias
             or conduction delays on ECG, unstable angina, or decompensated heart failure (New York
             Heart Association class III and IV)

          -  Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure
             at least 180 mmHg or sitting diastolic blood pressure at least 100 mmHg)

          -  Proliferative retinopathy or macular oedema requiring acute treatment

          -  Metformin contraindications according to the package insert

          -  Current treatment with systemic corticosteroids

          -  Subject has a history of any illness that, in the opinion of the investigator, might
             confound the results of the study or pose additional risk in administering study drug
             to the subject

          -  Current addiction to alcohol or other addictive substances as determined by the
             Investigator

          -  Mental incapacity, unwillingness or language barrier precluding adequate understanding
             or cooperation in the study or use of the glucose monitor

          -  History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes
             in the past year as judged by the Investigator