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OpenTrials
Completed

NCT Number: NCT00046462

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between 18 - 79 years of age
  • With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months

Exclusion criteria

  • Major cardiovascular events

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

Lantus (insulin glargine [rDNA origin] injection)

Drug

metformin

Drug

Glyburide

Drug

Thiazolidinedione

Drug

Primary outcomes

  1. To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy

    Time frame: During the Study Conduct

Secondary outcomes

  1. Occurrence of hypoglycemia

    Time frame: During the study conduct

  2. Change in fasting plasma glucose

    Time frame: During the study conduct

  3. Percentage of patients achieving HbA1C less than or equal to 7%

    Time frame: During the study conduct

  4. Time to glycemic control

    Time frame: During the study conduct

  5. Change in body weight

    Time frame: During the study conduct

  6. Change in serum lipid profile

    Time frame: During the study conduct

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Oct 2, 2002
Registry last updated
Jan 11, 2011

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.

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