NCT00546702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
Last Updated

June 15, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

October 18, 2007

Last Update Submit

June 12, 2009

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1c.

    from baseline to endpoint.

Secondary Outcomes (2)

  • Change in HbA1c.

    from baseline (week 1) to weeks 12 and 26

  • Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.

    from baseline to endpoint.

Interventions

Insuline GlulisineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

Moscow, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Olga Efremenkova

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

September 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

June 15, 2009

Record last verified: 2009-06

Locations

RU(1)