Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00653302

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Lantus (insulin glargine) + Glucophage (Metformin)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal). [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determination of the predictive criterion of HbA1c final [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Determination of the predictive criterion of weight variation [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]
HbA1c and weight variations (final value - basal value) [ Time Frame: during the study ] [ Designated as safety issue: No ]
AE/SAE evaluation [ Time Frame: from the informed consent signed up to the end of the study ]

Enrollment:	280
Study Start Date:	April 2003
Study Completion Date:	October 2005
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lantus once a day plus Glucophage 1000mg, twice a day per os	Drug: Lantus (insulin glargine) + Glucophage (Metformin)

Eligibility

Ages Eligible for Study:	30 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653302

Locations

France
Sanofi-aventis administrative office
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Nathalie Billon

Sanofi-aventis administrative office France

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis France ( Nathalie Billon/Study Director )
Study ID Numbers:	HOE901_4043
Study First Received:	April 1, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00653302 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 10, 2009