Clinical trial NCT00358124: Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
measure: Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
Secondary outcomes:
measure: Secondary efficacy parameters were: a mean change from baseline in FPG
measure: Mean change from baseline in fasting insulin/C-peptide levels
measure: Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
measure: Mean change from baseline for bodyweight.
measure: Health-related quality of life was compared between the baseline visit and the follow-up assessments
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Karen Barch
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.2337/diacare.29.03.06.dc05-0695.
citation: 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. doi: 10.2337/dc06-1712. Epub 2007 Jan 26.