Diabetes Type 2
Conditions
Brief summary
Primary objective: To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine. Secondary objective: To determine: change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.
Interventions
DRUGInsulin Glargine
Lantus (insulin glargine \[rDNA origin\] injection), individual dosing , subcutaneous injection, 100 IU/ml. Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment.
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
lists of inclusion and
Exclusion criteria
Inclusion Criteria: * Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months * Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide\> 3, 5 mg, glipizid \>5 mg, glimeperid \>2mg, metformin\>1000 mg, acarbose \>150 mg * HbA1c \> 7,0% * Ability to perform QoL assessment * Body Mass Indes: women \<30 and men \<32 Exlusion criteria: * Autoimmune diabetes, as defined by WHO * Ongoing treatment with tiasolidindion drug * Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry * Drug abuse * Hypersensitivity to insulin glagine excipients 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 |
|---|---|
| The fear of hypoglycaemia scale (HFS) | before the switch to insulin glargine and at 3 and 9 months of follow up. |
| 12 - Item Well-Being Questionnaaire (WBQ12) | before the switch to insulin glargine and at 3 and 9 months of follow up. |
| Glycaemic controll will be asessed by HbA1c values | week 12 and week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic hypoglycemia and severe hypoglycemia | sreening to follow-up phases |
Countries
Sweden
Outcome results
None listed