Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Lantus (insulin glargine) + Glucophage (Metformin) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Nathalie Billon, Study Director, Affiliation: Sanofi-aventis administrative office France
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
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Secondary outcome: Determination of the predictive criterion of HbA1c finalDetermination of the predictive criterion of weight variation HbA1c and weight variations (final value - basal value) AE/SAE evaluation
Eligibility
Minimum age: 30 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sanofi-aventis administrative office, Paris, France
Additional Information
Starting date: April 2003
Last updated: December 2, 2008
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