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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00518427
First received: August 17, 2007
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
 Drug: Insulin Glargine
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The fear of hypoglycaemia scale (HFS) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ] [ Designated as safety issue: No ]
  • 12 - Item Well-Being Questionnaaire (WBQ12) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ] [ Designated as safety issue: No ]
  • Glycaemic controll will be asessed by HbA1c values [ Time Frame: week 12 and week 40 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of symptomatic hypoglycemia and severe hypoglycemia [ Time Frame: sreening to follow-up phases ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518427

Locations
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Margareta Olsson-Birgersson sanofi-aventis, Sweden
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00518427     History of Changes
Other Study ID Numbers: HOE901_4057, Eudract #: 2005-000959-15
Study First Received: August 17, 2007
Last Updated: December 4, 2009
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013