Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine

Phase 4

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: Insulin Glargine

• Registration Number: NCT00518427
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Insulin Glargine	insulin glargine

Primary Outcome Measures

Name	Time	Method
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
The fear of hypoglycaemia scale (HFS)	before the switch to insulin glargine and at 3 and 9 months of follow up.

Secondary Outcome Measures

Name	Time	Method
Incidence of symptomatic hypoglycemia and severe hypoglycemia	sreening to follow-up phases

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden