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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00518427

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 IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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:	August 2005
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
Bromma, Sweden

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Margareta Olsson-Birgersson

sanofi-aventis, Sweden

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HOE901_4057, Eudract #: 2005-000959-15
Study First Received:	August 17, 2007
Last Updated:	September 28, 2008
ClinicalTrials.gov Identifier:	NCT00518427
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009