20 Week Bridging Study in Type II DM

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

Completed

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Key information

Conditions

Diabetes Mellitus Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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

Other names: Lantus

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Study completion: 2004
First posted: Nov 26, 2007
Registry last updated: Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed