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Glycemic Optimization Treatment Study (GOT)

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00552370
  Purpose

To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitis, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Lantus®
Phase IV

MedlinePlus related topics:   Diabetes    Hypoglycemia   

ChemIDplus related topics:   Insulin    Insulin glargine    Dextrose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).

Secondary Outcome Measures:
  • To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.

Enrollment:   5056
Study Start Date:   March 2003
Study Completion Date:   February 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Subjects must give their signed informed consent.
  2. Diagnosis of Type 2 DM for at least 6 months.
  3. Males and females greater than or equal to 18 years of age.
  4. A1c greater than or equal to 7.0%.
  5. Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
  6. Demonstrated willingness and ability to inject insulin glargine.
  7. Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
  8. Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
  9. BMI greater than 25.0 kg/m2.
  10. Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.

Exclusion Criteria:

  1. Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
  2. For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
  3. For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
  4. Planned pregnancy, pregnancy, or lactation.
  5. Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
  6. Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
  7. Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
  8. Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  9. Hypersensitivity to Lantus® insulin or any of its components.
  10. Any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study.
  11. Current (last 2 months) insulin therapy.
  12. With the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552370

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Karen Barch     Sanofi-Aventis    
  More Information


clinicalstudyresults.org  This link exits the ClinicalTrials.gov site
 

Responsible Party:   sanofi-aventis ( Study Director )
Study ID Numbers:   HOE901_4045
First Received:   October 31, 2007
Last Updated:   April 22, 2008
ClinicalTrials.gov Identifier:   NCT00552370
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on October 07, 2008




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