Text Size

Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00290979
First received: February 10, 2006
Last updated: August 25, 2009
Last verified: March 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Investigators
Study Director: Masayoshi KOYAMA Sanofi
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00290979     History of Changes
Other Study ID Numbers: EFC6167
Study First Received: February 10, 2006
Last Updated: August 25, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
HMR1964, insulin glulisine, Diabetes Mellitus, Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013