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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00518427
Other study ID # HOE901_4057
Secondary ID Eudract #: 2005-
Status Completed
Phase Phase 4
First received August 17, 2007
Last updated December 4, 2009
Start date October 2005
Est. completion date March 2008

Study information

Verified date December 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Sanofi-Aventis Administrative Office Bromma

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The fear of hypoglycaemia scale (HFS) before the switch to insulin glargine and at 3 and 9 months of follow up. No
Primary 12 - Item Well-Being Questionnaaire (WBQ12) before the switch to insulin glargine and at 3 and 9 months of follow up. No
Primary Glycaemic controll will be asessed by HbA1c values week 12 and week 40 No
Secondary Incidence of symptomatic hypoglycemia and severe hypoglycemia sreening to follow-up phases No
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