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Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00467376
First received: April 27, 2007
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Pregnant women

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
China
Sanofi-Aventis
Beijing, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jing Fu Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00467376     History of Changes
Other Study ID Numbers: APIDR_L_00348
Study First Received: April 27, 2007
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
 Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013