Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00539448

Purpose

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.
Recording adverse events.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin glargine Drug: insulin glulisine	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Phase IV, Open Label, Non-Comparative, Multi-Center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Evaluating the Glycemic control of the regimen : Change in A1C levels [ Time Frame: from baseline to study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? [ Time Frame: from baseline to study end ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental combination of insulin Glargine & insulin Glulisine as basal bolus regimen	Drug: insulin glargine in combination with insulin Glulisine as bolus regimen Drug: insulin glulisine in combination with insulin Glargine as bolus regimen

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed type I diabetic patients
Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
BMI, 26-40 kg/m2
HbA1c, 7.5%-10%
Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539448

Locations

Bahrain
Sanofi-aventis administrative office
Manama, Bahrain
Kuwait
Sanofi-aventis administrative office
Kuwait City, Kuwait
Qatar
Sanofi-Aventis Administrative Office
Doha, Qatar
United Arab Emirates
Sanofi-aventis administrative office
Dubai, United Arab Emirates

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Hisham - MAHMOUD, MD

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_L_01578
Study First Received:	October 3, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00539448
Health Authority:	United Arab Emirates : Ministry of Health

Study placed in the following topic categories:

Insulin glulisine
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009