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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467376
First Posted: April 30, 2007
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Change in HbA1c [ Time Frame: From baseline to endpoint ]
  • Adverse events [ Time Frame: From the beginning to the end of study ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: From baseline to weeks 12 ]
  • blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus. [ Time Frame: from baseline to week 12 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467376


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00467376     History of Changes
Other Study ID Numbers: APIDR_L_00348
First Submitted: April 27, 2007
First Posted: April 30, 2007
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs