Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00290979

Purpose

To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
To compare the safety of HMR1964 with insulin lispro.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin glulisine	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin lispro Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-Inferiority Study, for 28 Weeks

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro

Secondary Outcome Measures:

6-month safety data

Estimated Enrollment:	250
Study Start Date:	December 2004

Detailed Description:

To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
To collect 6-month safety data of HMR1964.

Eligibility

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

Criteria

Inclusion Criteria:

Men or women with type 1 diabetes mellitus, an HbA1C range of >=6.0 – =<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.

Exclusion Criteria:

Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
Subjects who were treated with another investigational product within 12 weeks prior to informed consent
Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult
Subjects who have undergone pancreatectomy or pancreas/islet cell transplant
Night shift workers
Subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
Subjects who have previously been treated with HMR1964
Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
Female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hCG) level > 0.7 mIU/mL as determined by central laboratory, SRL Medisearch Inc., during screening phase]
Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
Subjects with history of alcohol abuse
Subjects with hypersensitivity to insulin preparations
Subjects with impaired hepatic function (SGOT or SGPT ³=<80 IU/L determined by central laboratory, SRL Medisearch Inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dL determined by central laboratory, SRL Medisearch Inc., during screening phase)
Subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290979

Locations

Japan
Sanofi-Aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Masayoshi KOYAMA

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	EFC6167, HMR1964A
Study First Received:	February 10, 2006
Last Updated:	September 29, 2006
ClinicalTrials.gov Identifier:	NCT00290979
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi-Aventis:

HMR1964, insulin glulisine, Diabetes Mellitus, Type 1

Study placed in the following topic categories:

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

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009