Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

August 25, 2009 updated by: Sanofi

Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-week, Multinational, Multicenter Study

  • To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
  • To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
  • To evaluate the safety of HMR1964.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI < 30 kg/m2 , a HbA1C of > 8.0 - < 11.0% at screening
  • Fasting serum C-peptide at screening > 0.7 ng/mL
  • Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent
  • Glibenclamide > 5 mg/day
  • Glimepiride > 3 mg/day
  • Gliclazide > 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
  • Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week

Exclusion Criteria:

  • Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964
  • Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products
  • Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
  • Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)
Safety of HMR1964

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC6168

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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