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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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:

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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 orequivalent 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.