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Glulisine + Lantus in Type I Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00545337
First received: October 15, 2007
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Change of HbA1c [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of HbA1c [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
  • Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545337

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

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00545337     History of Changes
Other Study ID Numbers: HMR1964A_3505UA
Study First Received: October 15, 2007
Last Updated: October 15, 2009
Health Authority: Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on October 17, 2012