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Glulisine + Lantus in Type I Patients

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ClinicalTrials.gov Identifier: NCT00545337
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : October 16, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insuline glulisine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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

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.


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


Locations
Ukraine
Sanofi-Aventis
Kiev, Ukraine
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Volodymyr Moshchych Sanofi

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00545337     History of Changes
Other Study ID Numbers: HMR1964A_3505UA
First Posted: October 17, 2007    Key Record Dates
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