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

NCT ID: NCT00518427

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

insulin glargine

Group Type EXPERIMENTAL

Insulin Glargine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Margareta Olsson-Birgersson

Role: STUDY_DIRECTOR

sanofi-aventis, Sweden

Locations

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Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Eudract #: 2005-000959-15

Identifier Type: -

Identifier Source: secondary_id

HOE901_4057

Identifier Type: -

Identifier Source: org_study_id