Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

20 Week Bridging Study in Type II DM

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00563225
First received: November 21, 2007
Last updated: November 23, 2007
Last verified: November 2007
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus Type II
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Enrollment: 90
Study Start Date: October 2002
Study Completion Date: April 2004
Intervention Details:
    Drug: Insulin Glargine
    Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
    Other Name: Lantus
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563225

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Choe Seong Choon Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00563225     History of Changes
Other Study ID Numbers: HOE901_3506
Study First Received: November 21, 2007
Last Updated: November 23, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014