Status:
COMPLETED
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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: ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00941369
Start Date
June 1 2009
End Date
October 1 2012
Last Update
November 22 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Berlin, Germany