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

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358124
• Other study ID #: HOE901_4014
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2006
• Last updated: January 10, 2011
• Start date: January 2001
• Est. completion date: June 2002

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• insulin glargine

• rosiglitazone

• metformin

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2007 Jan 26. Erratum in: Diabetes Care. 2007 Jun;30(6):1684. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Primary	Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
Secondary	Secondary efficacy parameters were: a mean change from baseline in FPG
Secondary	Mean change from baseline in fasting insulin/C-peptide levels
Secondary	Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
Secondary	Mean change from baseline for bodyweight.
Secondary	Health-related quality of life was compared between the baseline visit and the follow-up assessments