Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 554

Inclusion Criteria

Diagnosed with T2DM duration of T2DM > 2 years

Insulin naÃ¯ve

Continuous treatment with stable doses of 2 OADs (sulphonylureas, biguanides, alpha-glucosidase inhibitors, DPP-IV inhibitors, and glinides) for > three months prior to randomization

HbA1c levels 7% and 11 %

Body mass index (BMI) 20 and 40 kg/m2

Willing and able to perform blood glucose monitoring using a blood glucose meter

Exclusion Criteria

Exclusion Criteria:
Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake),
Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for < 1 week)
Current treatment with thiazolidinediones
Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues
Current or previous (within the last 3 months) use of any treatment for weight loss
Active proliferative diabetic retinopathy
Patient with no written history of an eye examination in the past 6 months.
Treatment with systemic corticosteroids in the 3 months prior to study entry
Currently receiving treatment with monoamine oxidase inhibitors
Currently receiving treatment with non-selective ß-blockers
Treatment with any investigational product and/or device in the 2 months prior to study entry
Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol
History of ketoacidosis or hyperosmolar hyperglycemic state
History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months
History of congestive heart failure
History of hypoglycemia unawareness
Unexplained hypoglycemia in the past 6 months
Impaired renal function defined as, but not limited to, serum creatinine >/= 1.5 mg/dL (133 μmol/L) [males] or >/= 1.4 mg/dL (124 μmol/L) [females] or presence of macroproteinuria (> 2g/day)
Active liver disease (alanine transaminase [ALAT] greater than two times the upper limit of the reference range, as defined by the local laboratory)
Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol
Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia
Known hypersensitivity / intolerance to insulin glargine or any of its excipients
History of pancreatitis
Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma)
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
Shift workers or those who regularly work a night-time shift.
Any medical condition that may have an influence on HbA1c measurements e.g. sickle cell anaemia, Thalasemia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials