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

December 4, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Bromma, Sweden
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
insulin glargine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The fear of hypoglycaemia scale (HFS)
Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.
before the switch to insulin glargine and at 3 and 9 months of follow up.
12 - Item Well-Being Questionnaaire (WBQ12)
Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up.
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
week 12 and week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic hypoglycemia and severe hypoglycemia
Time Frame: sreening to follow-up phases
sreening to follow-up phases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Margareta Olsson-Birgersson, sanofi-aventis, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4057
  • Eudract #: 2005-000959-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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