Last updated: 11/07/2018 01:09:52

Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

GSK study ID
105517/346
See study documents
Clinicaltrials.gov ID
NCT00060918
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: carvedilol
  • Drug: metoprolol
    • 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
    • Inclusion criteria:
    • Patients at screening must be insulin producing Type II diabetics (C peptide positive).
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85050
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kalamazoo, Michigan, United States, 49009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    IDAHO FALLS, Idaho, United States, 83404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 50 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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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