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Glulisine + Lantus in Type I Patients

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: NCT00546702
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : June 15, 2009
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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 To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insuline Glulisine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 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 (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
Study Start Date : September 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Secondary Outcome Measures :
  1. Change in HbA1c. [ Time Frame: from baseline (week 1) to weeks 12 and 26 ]
  2. Blood glucose parameters, hypoglycaemic 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult men and women (>18 years) with 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 transplantats, 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 identifier (NCT number): NCT00546702

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Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
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Study Director: Olga Efremenkova Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00546702     History of Changes
Other Study ID Numbers: HMR1964A_3505
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 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