NCT00563225

Brief Summary

A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2002

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

November 21, 2007

Last Update Submit

November 23, 2007

Conditions

Diabetes Mellitus Type II

Outcome Measures

Primary Outcomes (1)

  • To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Secondary Outcomes (1)

  • To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.

Interventions

Insulin GlargineDRUG

Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)

Also known as: Lantus

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus diagnosed at least 3 years ago
  • Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
  • Treated with OHA monotherapy over at least 1 year
  • HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
  • BMI \< 40 kg/m2
  • No history of ketonemia
  • Women of childbearing potential using the medically approved contraceptive method
  • Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol
  • 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Choe Seong Choon

    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 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2002

Study Completion

April 1, 2004

Last Updated

November 26, 2007

Record last verified: 2007-11