Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

August 25, 2009 updated by: Sanofi

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
6-month safety data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Masayoshi KOYAMA, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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