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Result Summary for 49653/094

Result Summary
Protocol ID: 49653/094
Clinical Study ID: 49653/094
Official Title: A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) ...
Phase: Phase 3
Study Indications or Diseases:
  • Diabetes Mellitus, Type 2
Generic Name: rosiglitazone
Trade/Product Name: avandia;avandia
Approved Drug Label: http://www.gsk.com/products.html
Results Summary: Click here to download result summary. Click here to download result summary.
Citations:
  • Jones NP, Mather R, Owen S et al. Long-term efficacy of rosiglitazone as monotherapy or in combination with metformin. Diabetologia 2000; 43 (Suppl 1):A192. Abs and poster 736 presented at EASD 2000.
  • Matthews DR, Bakst A, Weston WM et al. Rosiglitazone decreases insulin resistance and improves beta-cell function in patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A229. Abs 858 presented at EASD 1999.
  • Jones TA, Sautter M, Van Gaal, LF et al. Addition of rosiglitazone to metformin is effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes, Obes & Metab2003;5:163-170
  • Fonseca V, Biswas N, Salzman A. Once daily rosiglitazone in combination with metformin effectively reduces hyperglycemia in patients with type 2 diabetes. Diabetes 1999; 48 (Suppl 1):A100. Abstract presented at ADA 1999.
  • Fonseca V, Biswas N, Patwardhan R et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus. JAMA 2000; 283:1695.1702.
  • Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921-930.
  • Fonseca V, Biswas N, Salzman A. Rosiglitazone in combination with metformin effectively reduces hyperglycemia in patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A864. Abstract + poster presented at EASD 1999.
  • Patwardhan R, Porter LE, Jones NP. Long-term efficacy of rosiglitazone as monotherapy or combination therapy in patients with type 2 diabetes mellitus. Abstract 1826 and poster presented at the US Endocrine Society Meeting, June 2000.

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