A Multicenter Clinical Trial to Evaluate Quality of Life in Patients With Type 2 Diabetes Before and After Changing Therapy to a Combination of Insulin Glargine and Oral Antidiabetic Drugs in a Real Life Situation
Overview
- Phase
- Phase 4
- Intervention
- Insulin Glargine
- Conditions
- Diabetes Type 2
- Sponsor
- Sanofi
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- 12 - Item Well-Being Questionnaaire (WBQ12)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
1
insulin glargine
Intervention: Insulin Glargine
Outcomes
Primary Outcomes
12 - Item Well-Being Questionnaaire (WBQ12)
Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.
Glycaemic controll will be asessed by HbA1c values
Time Frame: week 12 and week 40
The fear of hypoglycaemia scale (HFS)
Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.
Secondary Outcomes
- Incidence of symptomatic hypoglycemia and severe hypoglycemia(sreening to follow-up phases)