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Glulisine + Lantus in Type I Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00546702
First received: October 18, 2007
Last updated: June 12, 2009
Last verified: June 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 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 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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • Change in HbA1c. [ Time Frame: from baseline (week 1) to weeks 12 and 26 ] [ Designated as safety issue: No ]
  • Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins. [ Time Frame: from baseline to endpoint. ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: September 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546702

Locations
Russian Federation
Sanofi-aventis
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Olga Efremenkova Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00546702     History of Changes
Other Study ID Numbers: HMR1964A_3505
Study First Received: October 18, 2007
Last Updated: June 12, 2009
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation/Federal service of Russian Federation for Supervision in the sphere of Public Health and Social Development

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 May 23, 2013