Last updated: 11/07/2018 01:10:38
Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients with Type II Diabetes Mellitus.
Trial description: Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from baseline in HbA1c at 5 months
Timeframe: 5 months
Secondary outcomes:
Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
Timeframe: 5 months
Interventions:
Enrollment:
501
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bakris GL, Fonseca VF, Katholi RE, et al. GEMINI investigators. Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension. JAMA. 2004; 292: 2227-2236.
Demographic analyses of the effects of carvedilol vs. metoprolol in subjects with type 2 diabetes and hypertension in the gemini study. BELL, DAVID S. H., MCGILL, JANET B., FONSECA, VIVIAN, RASKIN, PHILIP, BAKRIS, GEORGE L., KATHOLI, RICHARD E., MESSERLI, FRANZ H., PHILLIPS, ROBERT A., WRIGHT, JACKSON T. JR, HOLDBROOK, FRED, ANDERSON, KAREN M., and LUKAS, MARY ANN 65th Annual Scientific Sessions of the American Diabetes Association 6/10/2005 San Diego, CA; USA
Differential effects of {beta}-blockers on albuminuria in patients with type 2 diabetes. Bakris, G. L., Fonseca, V., Katholi, R. E., McGill, J. B., Messerli, F., Phillips, R. A., Raskin, P., Wright, J. T. Jr, Waterhouse, B., Lukas, M. A., Anderson, K. M., and Bell, D. S. Hypertension 2005; 46(6):1309-15
Differential effects of î²-blockers in addition to blockers of the renin angiotensin system on the cardiovascular risk marker, microalbuminuria, in patients with type 2 diabetes and hypertension. Bakris, George L., Bell, David, Fonseca, Vivian, Katholi, Richard, McGill, Janet, Phillips, Robert, Raskin, Philip, Wright, Jackson T. Jr., Lukas, Mary Ann, Anderson, Karen M., and Holdbrook, Fred K. 54th Annual Scientific Session of the American College of Cardiology 3/6/2005 Orlando, FL; USA
I²-blockers in combination with renin antiotensin system blockade facilitate attaining blood pressure goals with differences in metabolic consequences. Wright, Jackson T Jr, Bakris, George L, Bell, David SH, Fonseca, Vivian, Katholi, Richard E, McGill, Janet B, Messerli, Franz H, Phillips, Robert A, Raskin, Philip, Lukas, Mary Ann, Anderson, Karen M, and Oakes, Rosemary 20th Annual Meeting of the American Society of Hypertension 5/14/2005 San Francisco, CA; USA
Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension: a randomized controlled trial. Bakris, G. L., Fonseca, V., Katholi, R. E., McGill, J. B., Messerli, F. H., Phillips, R. A., Raskin, P., Wright, J. T. Jr, Oakes, R., Lukas, M. A., Anderson, K. M., and Bell, D. S. JAMA 2004; 292(18):2227-36
Quality of life scores show improvement in diabetes symptoms on carvedilol vs metoprolol in gemini. BELL, DAVID S. H., BAKRIS, GEORGE L., MCGILL, JANET B., FONSECA, VIVIAN, RASKIN, PHILIP, MESSERLI, FRANZ H., PHILLIPS, ROBERT A., KATHOLI, RICHARD E., WRIGHT, JACKSON T. JR, IYENGAR, MALINI, ANDERSON, KAREN M., and LUKAS, MARY ANN 65th Annual Scientific Sessions of the American Diabetes Association 6/10/2005 San Diego, CA; USA
The rationale and design of the glycemic effects in diabetes mellitus carvedilol-metoprolol comparison in hypertensives (gemini) trial. Bakris, G. L., Bell, D. S., Fonseca, V., Katholi, R., McGill, J., Phillips, R., Raskin, P., Wright, J. T. Jr, Iyengar, M., Holeslaw, T., and Anderson, K. M. J Diabetes Complications 2005; 19(2):74-9
Weight changes and insulin sensitivity - not all beta-blockers are created equal. Messerli, F, Bakris, G, Bell, D, Fonseca, V, Katholi, R, McGill, J, Phillips, R, Raskin, P, Wright, J Jr, Lukas, M, Anderson, K, and Holdbrook, F 20th Annual Meeting of the American Society of Hypertension 5/14/2005 San Francisco, CA; USA
Medical condition
Hypertension
Product
carvedilol
Collaborators
Not applicable
Study date(s)
June 2001 to April 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
30 - 80 years
Accepts healthy volunteers
No
- Patients at screening must be insulin producing Type II diabetics (C peptide positive).
- Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
- Patients using beta-blocker therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients at screening must be insulin producing Type II diabetics (C peptide positive).
- Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
- Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
- Patients must be on stable antidiabetic regimen (drug treated or diet alone).
- Patient''s laboratory result for HbA1c must be 6.5
- 8.5 (drug treated) or 6.5
- 7.5 (diet alone).
Exclusion criteria:
- Patients using beta-blocker therapy.
Trial location(s)
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-2041
Status
Study Complete
Location
GSK Investigational Site
Summerville, South Carolina, United States, 29485
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Derby, Connecticut, United States, 06418
Status
Study Complete
Location
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
Status
Study Complete
Location
GSK Investigational Site
Gulfport, Mississippi, United States, 39501
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buffalo, New York, United States, 14209
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
West Evanston, Illinois, United States, 60202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23220
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Morrisville, Pennsylvania, United States, 19067
Status
Study Complete
Location
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
Status
Study Complete
Location
GSK Investigational Site
Saint Petersberg, Florida, United States, 33705
Status
Study Complete
Location
GSK Investigational Site
New Britain, Connecticut, United States, 06050
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01610
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38301
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28677
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Fredericksburg, Virginia, United States, 20401
Status
Study Complete
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Fulton, New York, United States, 13069
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Flushing, New York, United States, 11365
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20422
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38163
Status
Study Complete
Location
GSK Investigational Site
Liverpool, New York, United States, 13088
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10028
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Study Complete
Location
GSK Investigational Site
Columbia, Alabama, United States, 35051
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13202
Status
Study Complete
Location
GSK Investigational Site
Springfield, Virginia, United States, 22151
Status
Study Complete
Location
GSK Investigational Site
Sea Girt, New Jersey, United States, 08750
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Camden, New Jersey, United States, 08103
Status
Study Complete
Location
GSK Investigational Site
Margate, New Jersey, United States, 08402
Status
Study Complete
Location
GSK Investigational Site
New Hyde Park, New York, United States, 11040
Status
Study Complete
Location
GSK Investigational Site
Zanesville, Ohio, United States, 43701
Status
Study Complete
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
White River Junction, Utah, United States, 05009
Status
Study Complete
Location
GSK Investigational Site
Tonawanda, New York, United States, 14150
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01605
Status
Study Complete
Location
GSK Investigational Site
West Grove, Pennsylvania, United States, 19390
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40508
Status
Study Complete
Location
GSK Investigational Site
Miami, Florida, United States, 33176
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lancaster, New York, United States, 14043
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30901
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
Status
Study Complete
Location
GSK Investigational Site
Waltham, Massachusetts, United States, 02453
Status
Study Complete
Location
GSK Investigational Site
Linwood, New Jersey, United States, 08221
Status
Study Complete
Location
GSK Investigational Site
Haverhill, Massachusetts, United States, 01831-2451
Status
Study Complete
Location
GSK Investigational Site
Farmington, Connecticut, United States, 06030 - 1410
Status
Study Complete
Location
GSK Investigational Site
Fort Meyers, Florida, United States, 33907
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Philipsburgh, Pennsylvania, United States, 16966
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60616
Status
Study Complete
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06106
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Study Complete
Location
GSK Investigational Site
Waterford, Michigan, United States, 48328
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35211
Status
Study Complete
Location
GSK Investigational Site
Falls Church, Virginia, United States, 22044
Status
Study Complete
Location
GSK Investigational Site
Scarsdale, New York, United States, 10583
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Connellsville, Pennsylvania, United States, 15425
Status
Study Complete
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-06-04
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website