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Glulisine + Lantus in Type I Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 17, 2007
Last Update Posted: October 16, 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:
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus

Condition Intervention Phase
Diabetes Mellitus, Type 1 Drug: Insuline glulisine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change of HbA1c [ Time Frame: from baseline to endpoint ]

Secondary Outcome Measures:
  • Change of HbA1c [ Time Frame: from baseline to week 26 ]
  • Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins [ Time Frame: from baseline to endpoint ]

Enrollment: 60
Study Start Date: September 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

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:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type I diabetes mellitus (onset of diabetes under the age of 40),
  • an HbA1c range of >6.5 - <11%,
  • and on multiple injection regimen (more than 1 year of continuous insulin treatment),
  • body mass index <35.

Exclusion Criteria:

  • Active proliferative diabetic retinopathy,
  • Diabetes other than type I diabetes mellitus,
  • Pancreatectomised subjects,
  • Subjects who have undergone pancreas and or islet cell transplants,
  • Requiring treatment with not permited drugs during the study,
  • Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
  • Hypersensitivity to insulin,
  • Major systemic diseases,
  • Impaired hepatic or renal function

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): NCT00545337

Kiev, Ukraine
Sponsors and Collaborators
Study Director: Volodymyr Moshchych Sanofi
  More Information

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00545337     History of Changes
Other Study ID Numbers: HMR1964A_3505UA
First Submitted: October 15, 2007
First Posted: October 17, 2007
Last Update Posted: October 16, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases