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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358124
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 11, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: insulin glargine Drug: rosiglitazone Drug: metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2001
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00358124

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: Karen Barch Sanofi
Layout table for additonal information Identifier: NCT00358124    
Other Study ID Numbers: HOE901_4014
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs