Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

Type 2 Diabetes Clinical Trial

— GALATEE  

Official title:

Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653302
• Other study ID #: HOE901_4043
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2008
• Last updated: December 2, 2008
• Start date: April 2003
• Est. completion date: October 2005

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Primary objective:

• Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

• Determination of the predictive criterion of HbA1c final,

• Determination of the predictive criterion of weight variation,

• Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),

• Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

• Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

Inclusion Criteria:

• Known type 2 diabetes for at least 2 years

• No history of Ketoacidosis

• BMI> 25 & <35 kg/m2

• Type 2 diabetes treated with oral bi or tritherapy for at least 6 months

• With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),

• and metformin at minimal posology 1700mg/day (1320 mg of metformin),

• HbA1c >= 7.5 and <11% for 2 different dosages during the last year

Exclusion Criteria:

• Type 1 diabetes

• Glucophage intolerability

• Pregnancy

• Breast feeding

• Partial pancreatectomy

• Hypersensitivity to insulin glargine excipient

• Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient

• Hepatitis with transaminases >3ULN

• Pre-proliferative or proliferative retinopathy

• Acute cardiovascular accident within the last 6 months

• Previous treatment with insulin within the last 6 months before randomization

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

• Type 2 Diabetes

Intervention

Drug:
• Lantus (insulin glargine) + Glucophage (Metformin)

Locations

Country	Name	City	State
France	Sanofi-aventis administrative office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).		During the study conduct	No
Secondary	Determination of the predictive criterion of HbA1c final		During the study conduct	No
Secondary	Determination of the predictive criterion of weight variation		During all the study conduct	No
Secondary	HbA1c and weight variations (final value - basal value)		during the study	No
Secondary	AE/SAE evaluation		from the informed consent signed up to the end of the study