Insulin Glargine v Rosiglitazone as Add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00358124

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 IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

Further study details as provided by Sanofi-Aventis:

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

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-Aventis

Investigators

Study Director:

Karen Barch

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care. 2006 Mar;29(3):554-9.

Vinik AI, Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007 Apr;30(4):795-800. Epub 2007 Jan 26. Erratum in: Diabetes Care. 2007 Jun;30(6):1684.

Study ID Numbers:	HOE901/4014
Study First Received:	July 28, 2006
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00358124
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009