COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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

Layout table for study information
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

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.

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

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 identifier (NCT number): NCT00397553

Layout table for location information
Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Layout table for investigator information
Study Director: Marina Atarshchikova, MD Sanofi

Layout table for additonal information
Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00397553    
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:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs