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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518427
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : December 7, 2009
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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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Insulin Glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2005
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. The fear of hypoglycaemia scale (HFS) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ]
  2. 12 - Item Well-Being Questionnaaire (WBQ12) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ]
  3. Glycaemic controll will be asessed by HbA1c values [ Time Frame: week 12 and week 40 ]

Secondary Outcome Measures :
  1. Incidence of symptomatic hypoglycemia and severe hypoglycemia [ Time Frame: sreening to follow-up phases ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518427

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00518427     History of Changes
Other Study ID Numbers: HOE901_4057
Eudract #: 2005-000959-15
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs