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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Lantus (insulin glargine) + Glucophage (Metformin)

• Registration Number: NCT00653302
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-09
• Study Completion: 2005-10
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-02
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lantus (insulin glargine) + Glucophage (Metformin)	Lantus once a day plus Glucophage 1000mg, twice a day per os

Primary Outcome Measures

Name	Time	Method
% 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

Secondary Outcome Measures

Name	Time	Method
AE/SAE evaluation	from the informed consent signed up to the end of the study
HbA1c and weight variations (final value - basal value)	during the study
Determination of the predictive criterion of HbA1c final	During the study conduct
Determination of the predictive criterion of weight variation	During all the study conduct

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇫🇷 Paris, France