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

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ClinicalTrials.gov Identifier: NCT00518427
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE August 17, 2007
First Posted Date  ICMJE August 20, 2007
Last Update Posted Date December 7, 2009
Study Start Date  ICMJE October 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • The fear of hypoglycaemia scale (HFS) [ Time Frame: 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. ]
  • Glycaemic controll will be asessed by HbA1c values [ Time Frame: week 12 and week 40 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2007)
  • Diabetes Treatment Satisfaction Questionnaire (DTSQ)
  • The fear of hypoglycaemia scale (HFS)
  • 12 - Item Well-Being Questionnaaire (WBQ12)
  • Glycaemic controll will be asessed by HbA1c values
Change History Complete list of historical versions of study NCT00518427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Incidence of symptomatic hypoglycemia and severe hypoglycemia [ Time Frame: sreening to follow-up phases ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2007)
Incidence of symptomatic hypoglycemia and severe hypoglycemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Type 2
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 1
insulin glargine
Intervention: Drug: Insulin Glargine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2008)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2007)
40
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00518427
Other Study ID Numbers  ICMJE HOE901_4057
Eudract #: 2005-000959-15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Margareta Olsson-Birgersson sanofi-aventis, Sweden
PRS Account Sanofi
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP