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

NCT00518427 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-12-07

No results posted yet for this study

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

  • Diabetes Type 2

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Margareta Olsson-Birgersson · sanofi-aventis, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518427 on ClinicalTrials.gov