Glulisine + Lantus in Type I Patients - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00546702

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 III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change of HbA1c. [ Time Frame: from baseline to endpoint. ]

Secondary Outcome Measures:

Change in HbA1c. [ Time Frame: from baseline (week 1) to weeks 12 and 26 ]
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.

Enrollment:	142
Study Start Date:	May 2004
Study Completion Date:	April 2005

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-Aventis

Investigators

Study Director:

Olga Efremenkova

Sanofi-Aventis

More Information

Study ID Numbers:	HMR1964A_3505_RU
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00546702
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

Study placed in the following topic categories:

Insulin glulisine
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009