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OpenTrials
Completed

NCT Number: NCT00518427

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  1. Incidence of symptomatic hypoglycemia and severe hypoglycemia

    Time frame: sreening to follow-up phases

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: QoL

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2007
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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