Clinical Trials Directory

Trials / Completed

CompletedNCT00518427

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGInsulin GlargineLantus (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.

Timeline

Start date
2005-10-01
Primary completion
2008-03-01
Completion
2008-03-01
First posted
2007-08-20
Last updated
2009-12-07

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT00518427. Inclusion in this directory is not an endorsement.