Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00467376

Purpose

Primary:

To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Insulin Glulisine Drug: Lispro Drug: Insulin Glargine	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Insulin lispro Insulin glulisine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	12-Week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Hypoglycemic episodes [ Time Frame: From the beginning to end of the study ] [ Designated as safety issue: No ]
Change in HbA1c [ Time Frame: From baseline to endpoint ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: From the beginning to the end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in HbA1c [ Time Frame: From baseline to weeks 12 ] [ Designated as safety issue: No ]
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus. [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment:	485
Study Start Date:	January 2007
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Administration of Insulin Glulisine	Drug: Insulin Glulisine 3 times a day before each meal Drug: Insulin Glargine once daily
2: Active Comparator Administration of Lispro	Drug: Lispro 3 times a day before each meal Drug: Insulin Glargine once daily

Eligibility

Criteria

Inclusion Criteria:

Type 1 or type 2 diabetic patients
Measure HbA1c 6.5% to 11.0% at visit 1
More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

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: NCT00467376

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jing Fu

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	APIDR_L_00348
Study First Received:	April 27, 2007
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00467376
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Insulin glulisine
Metabolic Diseases
Glargine
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009