Diabetes mellitus type 2
Conditions
Interventions
Trade Name: Lantus
Product Name: Insulin glargine
Product Code: HOE 901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
Current Sponsor code: HOE901
Concentration un
Sponsors
Sanofi-Aventis Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written Informed Consent must be obtained for all patients before commencement in the study at visit 1 (Appendix A: Informed Consent document). Subjects meeting all of the following inclusion criteria will be considered for enrollment into the study: 1. Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria (24) 2. Treatment with one or maximum two oral antihyperglycemic agents on a stable dosage during at least at the last 4 weeks from the following substances/substance classes: metformin, sulfonylurea, DPP-IV inhibitors. 3. No pre-treatment with any insulin in the last 3 months before the study. 4. HbA1c value between = 7.0% and = 10.0%. 5. FBG = 120 mg/dl (6.7 mmol/l). 6. Men and women aged between 18-80 years inclusive. 7. Body mass index > 22 kg/m²and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes mellitus. 2. Any history of ketoacidosis 3. Pregnancy (as determined by pregnancy serum test at visit 1). 4. Prior treatment with insulin within the last 3 months before the study 5. Treatment with more than two oral agents within the last 4 weeks or continuous treatment with thiazolidinediones or GLP-1 receptor agonists. 6. History of drug or alcohol abuse. 7. Diabetic retinoathy 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. 8. Following pancreatectomy. 9. Impaired hepatic function, as shown by, but not limited to, SGPT (ALAT) or SGOT (ASAT), above 2x the upper limit of normal measured at visit 1. 10. Impaired renal function, as shown by, but not limited to, serum creatinine > 177 µmol/l (> 2.0 mg/dl) measured at visit 1. 11. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. 12. Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment. 13. Inability to attend the visits according to the study schedule. 14. Absence of adequate contraception 15. Current treatment because of a psychiatric disease. 16. Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor. 17. Systemic corticoids > 7,5 mg prednisolon equivalent or = 7,5 mg prednisolon equivalent for less than 2 months. 18. Current participation in other clinical studies or participation in a clinical study during the last 3 months prior to participation in this study. 19. Patient underwent bariatric surgery for weight reduction (e.g. gastric banding) 20. Patient undertook major dietary changes for weight management during the last 3 months prior to participation in this study, resulting in weight reduction of at least 5kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Health Assessment, Patient treatment satisfaction and Quality-of-Life ;Main Objective: Investigate the impact of insulin glargine vs. NPH basal insulin on a composite diabetes related quality of life score (DRQoL), consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), the Problem Areas in Diabetes Questionnaire score (PAID) and the mental health score of the SF 12® Health Survey (SF 12®). The treatments consist of a combination therapy of oral antidiabetic agents and either insulin glargine or NPH basal insulin;Secondary Objective: Comparison of combination therapy with insulin glargine vs. NPH basal insulin from baseline to endpoint in terms of: - Glycaemic parameters: change in HbA1c, fasting blood glucose, 7 point glucose profile, total daily insulin dose at endpoints - Incidence of confirmed symptomatic hypoglycemia (ADA criteria) as well as confirmed severe hypoglycemia (third party assistance, according to ADA criteria) - Change in lipid status (total cholesterol, HDL, LDL, triglycerides), change in body weight - Health Assessment, Patient treatment satisfaction and Quality-of-Life | — |
Countries
Germany
Outcome results
None listed