NCT00467376

Brief Summary

Primary:

  • To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
  • To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Secondary:
  • To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Trial Health

80
On Track

Trial Health Score

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

Enrollment
485

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

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, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.4 years

First QC Date

April 27, 2007

Last Update Submit

September 14, 2009

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Hypoglycemic episodes

    From the beginning to end of the study

  • Change in HbA1c

    From baseline to endpoint

  • Adverse events

    From the beginning to the end of study

Secondary Outcomes (2)

  • Change in HbA1c

    From baseline to weeks 12

  • blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.

    from baseline to week 12

Study Arms (2)

1

EXPERIMENTAL

Administration of Insulin Glulisine

Drug: Insulin GlulisineDrug: Insulin Glargine

2

ACTIVE COMPARATOR

Administration of Lispro

Drug: LisproDrug: Insulin Glargine

Interventions

Insulin GlulisineDRUG

3 times a day before each meal

1
LisproDRUG

3 times a day before each meal

2
Insulin GlargineDRUG

once daily

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetic patients
  • Measure HbA1c 6.5% to 11.0% at visit 1
  • More than 3 months of continuous insulin treatment immediately prior to study entry

You may not qualify if:

  • Pregnant women
  • 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

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin glulisineInsulin LisproInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Jing Fu

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

CN(1)