Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Study Details
Study Description
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:
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Glycaemic parameters: 7 blood glucose profiles
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Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
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Change in lipid status
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1 Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen |
Drug: Insulin 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.
|
Active Comparator: 2 Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen |
Drug: Insulin 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion criteria:
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Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
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Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
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No pre-treatment with any insulin in the last 3 months before the study.
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Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%
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Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).
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Body mass index < 40 kg/m.
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Ability to read and understand German language.
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Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
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Women of childbearing potential who will take adequate contraceptive protection.
Exclusion criteria:
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Patients with type 1 diabetes mellitus.
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Any history of ketoacidosis.
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Pregnancy.
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Prior treatment with insulin.
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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.
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History of drug or alcohol abuse.
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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.
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Following pancreatectomy.
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Impaired hepatic function.
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Impaired renal function.
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Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
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Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
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Inability to attend follow-up visits.
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Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).
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Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sanofi-Aventis Administrative Office | Berlin | Germany |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Heinz Riederer, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LANTU_L_04079
- 2009-019013-59(EudraCT)