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Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00358124
First received: July 28, 2006
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: insulin glargine
Drug: rosiglitazone
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
  • Other efficacy variables were the change from baseline in FPG, serum lipids and weight.

Secondary Outcome Measures:
  • Secondary efficacy parameters were: a mean change from baseline in FPG
  • Mean change from baseline in fasting insulin/C-peptide levels
  • Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
  • Mean change from baseline for bodyweight.
  • Health-related quality of life was compared between the baseline visit and the follow-up assessments

Estimated Enrollment: 220
Study Start Date: January 2001
Estimated Study Completion Date: June 2002
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Diagnosis of type 2 diabetes mellitus for at least one year;
  • Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
  • Glycated hemoglobin between 7.5 and 11 % units, inclusive;
  • Willingness to accept, and ability to inject insulin glargine therapy

EXCLUSION CRITERIA:

  • Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
  • Congestive heart failure requiring pharmacological treatment;
  • Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  • Planned radiological examinations requiring administration of contrasting agents;
  • Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
  • History of hypoglycemia unawareness;
  • Pregnancy or lactation;
  • Failure to use adequate contraception (women of current reproductive potential only);
  • Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
  • BMI >25 kg/m2;
  • Malignancy except basal cell carcinoma within the last five years;
  • History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
  • Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
  • Incapability to comply with study procedures
  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: NCT00358124

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Karen Barch Sanofi
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00358124     History of Changes
Other Study ID Numbers: HOE901_4014
Study First Received: July 28, 2006
Last Updated: January 10, 2011
Health Authority: United States: 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
Metformin
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014