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

Study Overview
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Brief Summary
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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

Official Title
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Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine (HOE901)/NPH Insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen | Drug: Insulin Glargine (HOE901)/NPH Insulin<br>* 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.<br>|
| Active Comparator: 2<br>Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen | Drug: Insulin Glargine (HOE901)/NPH Insulin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |