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
Showing 1 - 6 of 118 Results
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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