Last updated: 11/07/2018 14:47:17
A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCoA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL 49653C) 4mg bd
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCoA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL 49653C) 4mg bd
Trial description: A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCoA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL 49653C) 4mg bd
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ayyobi A. Lipoprotein abnormalities in type 2 diabetes is related to central obesity and insulin resistance. Poster presented at Kern Aspen Lipid Conference 2002.
Ayyobi AY, Knopp RH Khan SE et al. Abnormal lipoprotein distribution in type 2 diabetes: comparison to insulin sensitive and resistant normals. Diabetes 2002; 51 (Suppl 2). Abs 607-P and poster presented at ADA 2002.
Brunzell J, Cohen BR, Kreider M, et al. Rosiglitazone favorably affects LDL-C and HDL-C heterogeneity in type 2 diabetes. Diabetes 2001; 50 (Suppl 2):A141.Abs 567-P presented at ADA 2001.
Cohen B, Kreider M, Biswas N, et al. Rosiglitazone in combination with an HMG CoA reductase inhibitor: safety and effects on lipid profile in patients with type 2 diabetes. Diabetes 2001; 50 (Suppl 2):A451. Abs 1884-PO presented at ADA 2001.
Freed MI, Ratner R, Marcovina SM, et al. Effects of rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus. Am J Cardiol 2002; 90:947952.
Gottesman IS, Cohen BR, Kreider M, et al. Rosiglitazone in combination with an HMG CoA reductase inhibitor: safety and effects on lipid profile in patients with type 2 diabetes. Can J Diabetes Care 2001; 25(3). Poster 171 presented at 5th Annual CDA/CSEM Professional Conference 2001.
Kreider M, Cohen B, Freed MI, et al. Rosiglitazone in combination with a statin: effect on lipid profile in patients with type 2 diabetes mellitus. Published in ENDO 2001 congress book; Abstract # 35063 and poster P3-55
Leiter L, Cohen B, Kreider M, et al. Rosiglitazone favourably affects LDL-C and HDL-C heterogeneity in type 2 diabetes. Can J Diabetes Care 2001; 25(3). Poster 169 presented at 5th Annual CDA/CSEM Professional Conference 2001.
Stewart M, Jones NP, Kreider M, et al. Combined effects of rosiglitazone and atorvastatin on the dyslipidaemia associated with type 2 diabetes. Diabetologia 2001; 44 (Suppl 1):A222. Abs 854 presented at EASD 2001.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 1999 to July 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-26-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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