Last updated: 11/07/2018 01:09:52
Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus 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 Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.
Trial description: To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers 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 values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
Timeframe: 5 months
Interventions:
Enrollment:
1210
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).
- Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
- Patients using beta-blocker therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients at screening must be insulin producing Type II diabetics (C peptide positive).
- Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
- Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
- Patient''s laboratory result for HbA1c must be 6.5
- 8.5 (drug treated) or 6.5
- 7.5 (diet alone).
- Must be on a stable antidiabetic regimen (drug treated or diet alone).
Exclusion criteria:
- Patients using beta-blocker therapy.
Trial location(s)
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
IDAHO FALLS, Idaho, United States, 83404
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Hemet, California, United States, 92543
Status
Study Complete
Location
GSK Investigational Site
Oak Park, Michigan, United States, 48237
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92102
Status
Study Complete
Location
GSK Investigational Site
O'Fallon, Illinois, United States, 62269
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92501
Status
Study Complete
Location
GSK Investigational Site
The Colony, Texas, United States, 75056
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46515
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91105
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53151
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Study Complete
Location
GSK Investigational Site
Renton, Washington, United States, 98055
Status
Study Complete
Location
GSK Investigational Site
Concord, California, United States, 94520
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Oregon City, Oregon, United States, 97045
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63128
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78299
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78259
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64106
Status
Study Complete
Location
GSK Investigational Site
San Luis Obispo, California, United States, 93405
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32401
Status
Study Complete
Location
GSK Investigational Site
Burlingame, California, United States, 94010
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
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
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Access to clinical trial data by researchers
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