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

Diabetes Type 2 Clinical Trial

— QoL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518427
• Other study ID #: HOE901_4057
• Secondary ID: Eudract #: 2005-
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2007
• Last updated: December 4, 2009
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Insulin 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.

Locations

Country	Name	City	State
Sweden	Sanofi-Aventis Administrative Office	Bromma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fear of hypoglycaemia scale (HFS)		before the switch to insulin glargine and at 3 and 9 months of follow up.	No
Primary	12 - Item Well-Being Questionnaaire (WBQ12)		before the switch to insulin glargine and at 3 and 9 months of follow up.	No
Primary	Glycaemic controll will be asessed by HbA1c values		week 12 and week 40	No
Secondary	Incidence of symptomatic hypoglycemia and severe hypoglycemia		sreening to follow-up phases	No