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

NCT00518427 | Completed Phase 4

• 2 other identifiers: HOE901_4057Eudract #: 2005-000959-15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (3)

• The fear of hypoglycaemia scale (HFS)

  before the switch to insulin glargine and at 3 and 9 months of follow up.

• 12 - Item Well-Being Questionnaaire (WBQ12)

  before the switch to insulin glargine and at 3 and 9 months of follow up.

• Glycaemic controll will be asessed by HbA1c values

  week 12 and week 40

Secondary Outcomes (1)

• Incidence of symptomatic hypoglycemia and severe hypoglycemia

  sreening to follow-up phases

Study Arms (1)

1

EXPERIMENTAL

insulin glargine

Drug: Insulin Glargine

Interventions

Insulin Glargine DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Margareta Olsson-Birgersson

  sanofi-aventis, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 20, 2007
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

SE (1)