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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin Lispro
Insulin glulisine
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014