NCT00397553

Brief Summary

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Trial Health

80
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P25-P50 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

January 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

September 18, 2009

Status Verified

May 1, 2009

Enrollment Period

2.9 years

First QC Date

November 8, 2006

Last Update Submit

September 17, 2009

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    52 weeks

Secondary Outcomes (5)

  • HbA1c

    26 weeks

  • Fasting Blood Glucose

    26 weeks

  • Fasting Blood Glucose

    52 weeks

  • Post-prandial glycemia (2 hour after breakfast)

    26 weeks

  • Post-prandial glycemia (2 hour after breakfast)

    52 weeks

Study Arms (1)

Insulin Glulisine

EXPERIMENTAL
Drug: Insulin glulisine

Interventions

Insulin glulisineDRUG
Insulin Glulisine

Eligibility Criteria

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

You may qualify if:

  • Diabetes mellitus, Type 1
  • HbA1c 6.5-11.0%
  • BMI \<35 kg/m²

You may not qualify if:

  • Diabetes mellitus, Type 2
  • 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

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marina Atarshchikova, MD

    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

November 8, 2006

First Posted

November 9, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Last Updated

September 18, 2009

Record last verified: 2009-05

Locations

RU(1)