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Glycemic Optimization Treatment Study (GOT)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00552370
First received: October 31, 2007
Last updated: July 20, 2009
Last verified: July 2009
History of Changes
  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 mellitus, 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel-Design Trial. Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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). [ Time Frame: From the start to the end of the study ] [ Designated as safety issue: No ]

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. [ Time Frame: From the start to the end of the study ] [ Designated as safety issue: No ]

Enrollment: 5062
Study Start Date: March 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Karen Barch Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00552370     History of Changes
Other Study ID Numbers: HOE901_4045
Study First Received: October 31, 2007
Last Updated: July 20, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013