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Insulin Glulisine, Diabetes Mellitus Type 1

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.
ClinicalTrials.gov Identifier: NCT00397553
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insulin glulisine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
Study Start Date : January 2005
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin Glulisine Drug: Insulin glulisine



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 26 weeks ]
  2. Fasting Blood Glucose [ Time Frame: 26 weeks ]
  3. Fasting Blood Glucose [ Time Frame: 52 weeks ]
  4. Post-prandial glycemia (2 hour after breakfast) [ Time Frame: 26 weeks ]
  5. Post-prandial glycemia (2 hour after breakfast) [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus, Type 1
  • HbA1c 6.5-11.0%
  • BMI <35 kg/m²

Exclusion Criteria:

  • Diabetes mellitus, Type 2

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


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): NCT00397553


Locations
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Russian Federation
Sanofi-Aventis
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Marina Atarshchikova, MD Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00397553     History of Changes
Other Study ID Numbers: HMR1964A_3517
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs