Diabetes Mellitus, Type 2
Conditions
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: 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
Interventions
DRUGInsulin Glargine (HOE901)/NPH Insulin
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Assessment, Patient treatment satisfaction and Quality-of-Life | At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint) |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic parameters assessment | At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) |
| Anteropometric data (Weight, waist circumference) assessment | At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) |
| Lipid assessment | At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) |
| Hypoglycemia assessment | Throughout the study from starting until the week 48 |
Countries
Germany
Outcome results
None listed