Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Primary Objective:

 To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin
 on a composite diabetes related quality of life score (DRQoL).

 Secondary Objective:

 A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn
 basal insulin from baseline to endpoint in terms of:

 -  Glycaemic parameters: 7 blood glucose profiles

 -  Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia

 -  Change in lipid status
Inclusion criteria:

 -  Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA
 criteria.

 -  Treatment with a combination of maximum 2 substance classes on a stable dosage during
 the last 3 months: metformin and/or sulfonylurea.

 -  No pre-treatment with any insulin in the last 3 months before the study.

 -  Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%

 -  Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).

 -  Body mass index < 40 kg/m.

 -  Ability to read and understand German language.

 -  Ability and willingness to follow a tight antidiabetic therapy and to perform blood
 glucose self monitoring on a regular basis.

 -  Women of childbearing potential who will take adequate contraceptive protection.

 Exclusion criteria:

 -  Patients with type 1 diabetes mellitus.

 -  Any history of ketoacidosis.

 -  Pregnancy.

 -  Prior treatment with insulin.

 -  Treatment with more than two oral agents within the last 3 months or continuous
 treatment with thiazolidinediones, GLP-1 receptor agonists or with
 Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.

 -  History of drug or alcohol abuse.

 -  Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in
 the last 3 months prior to study entry or which may require surgical treatment within
 3 months of study entry.

 -  Following pancreatectomy.

 -  Impaired hepatic function.

 -  Impaired renal function.

 -  Mental condition rendering the patient unable to understand the nature, scope and
 possible consequences of the study.

 -  Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic)
 treatment.

 -  Inability to attend follow-up visits.

 -  Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).

 -  Patients that are in a relationship of dependance with the investigator(s) and/or the
 sponsor.

 -  Systemic corticoids > 7,5 mg prednisolon equivalent or <or=7,5 mg prednisolon
 equivalent for less than 2 months.

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.