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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 final

Determination 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 ┬Ámol/L for male and >110 ┬Ámol/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

Page last updated: August 23, 2015

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