Type 2 diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Insulin glargine initiated by group education versus insulin glargine initiated by teach each individual patient.
Sponsors
sanofi-aventis Oy (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged greater or equal to 18 years of age with type two diabetes 2. Treated with a stable dose (any dose) of sulfonylurea and metformin (1.5 grams or more) or either drug alone for at least six months 3. Body Mass Index (BMI) less than 45 kg/m^2 4. HbA1c between 7.0 and 12% 5. Willingness and ability to inject insulin and perform self-monitoring of blood glucose and to share some health information (glycemic control and body weight) with other members of the group
Exclusion criteria
Exclusion criteria: 1. Insulin therapy during the preceding 12 months 2. Impaired renal function, as shown by (but not limited to) serum creatinine more than 177 µmol/L (more than 2.0 mg/dL) measured at visit one or current renal dialysis 3. Gross proteinuria (dU-prot more than 3 g) at screening 4. Known acute or chronic metabolic acidosis, including diabetic ketoacidosis 5. Clinical evidence of active liver disease, or serum Alanine Aminotransferase (ALT) more than 2.5 times the upper limit of the normal range 6. History of hypoglycemia unawareness 7. Repeated (more than one) severe hypoglycemia with unconsciousness within the last year 8. Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding three months of study entry, or requiring treatment within three months after the study entry 9. Pregnancy or lactation 10. Failure to use adequate contraception (women of current reproductive potential only), e.g. use of systemic hormones (oral contraceptives or an implant), an intrauterine device, or a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom) 11. Known hypersensitivity to insulin glargine, or any of the excipients 12. Malignancy (except for basal cell skin cancer) within the last five years 13. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. non-cardioselective Beta-blockers, systemic corticosteroids, thiazolidinediones) months 14. Known adrenal insufficiency 15. Known haemoglobinopathy or moderate to severe anemia (i.e. hemoglobin concentration less than 110 g/dl) 16. Psychiatric condition rendering the subject unable to understand the nature, scope, and possible consequences of the study 17. History of substance or alcohol abuse within the last two years, or current substance abuse 18. Inability to comply with study procedures 19. Any clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult 20. Known positive test result for Glutamic Acid Decarboxylase (GAD), or islet cell antibodies 21. Type one Diabetes Mellitus, as defined by the World Health Organisation (WHO) 22. Use of an investigational drug during the last six months before study entry 23. Inability to stop current treatment with thiazolidinedione
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether insulin therapy with insulin glargine can be initiated as effectively by group education as by teaching each patient individually. Programs are defined as equally successful if the HbA1c differs less than 0.5% at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost of initiation of insulin therapy including: time spent by a nurse on education, physician?s time, number and duration of phone calls 2. Change in the concentrations of serum total, High Density Lipoproteins (HDL) and Low Density Lipoproteins (LDL) cholesterol, and serum triglycerides (visit 12 versus visit three) 3. Change in body weight and blood pressure (visit 12 versus visit three) 4. Change in the fasting plasma glucose concentration (visit 12 versus visit three) 5. Insulin dose at visit 12 6. Change in subject?s treatment satisfaction (measured by the Diabetes Treatment Satisfaction Questionnaire [DTSQ]) (visit 12 versus visit three) | — |
Countries
Finland, Netherlands, Sweden, United Kingdom
Outcome results
None listed