Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Hypertension |
Intervention | Drug: carvedilol Drug: metoprolol |
Phase | Phase 4 |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT00060918 |
First Received | May 15, 2003 |
Last Updated | April 11, 2013 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 15, 2003 |
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Last Updated Date | April 11, 2013 |
Start Date | June 2001 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Change from baseline in HbA1c at 5 months [Time Frame: 5 months] |
Current Secondary Outcome Measures | 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. [Time Frame: 5 months] |
Descriptive Information[ + expand ][ + ]
Brief Title | Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension |
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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. |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Hypertension |
Intervention | Drug: carvedilol Drug: metoprolol Other Names:
|
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1210 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility 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. |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00060918 |
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Other Study ID Numbers | 105517/346 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
GSK Investigational Site | Glendale, Arizona, United States, 85306 |
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GSK Investigational Site | Phoenix, Arizona, United States, 85050 |
GSK Investigational Site | Phoenix, Arizona, United States, 85016 |
GSK Investigational Site | Tucson, Arizona, United States, 85724 |
GSK Investigational Site | Burlingame, California, United States, 94010 |
GSK Investigational Site | Concord, California, United States, 94520 |
GSK Investigational Site | Encinitas, California, United States, 92024 |
GSK Investigational Site | Hemet, California, United States, 92543 |
GSK Investigational Site | Long Beach, California, United States, 90806 |
GSK Investigational Site | Orange, California, United States, 92868 |
GSK Investigational Site | Pasadena, California, United States, 91105 |
GSK Investigational Site | Riverside, California, United States, 92501 |
GSK Investigational Site | San Diego, California, United States, 92102 |
GSK Investigational Site | San Luis Obispo, California, United States, 93405 |
GSK Investigational Site | Spring Valley, California, United States, 91978 |
GSK Investigational Site | Aurora, Colorado, United States, 80045 |
GSK Investigational Site | Denver, Colorado, United States, 80220 |
GSK Investigational Site | Golden, Colorado, United States, 80401 |
GSK Investigational Site | Panama City, Florida, United States, 32401 |
GSK Investigational Site | St. Petersburg, Florida, United States, 33701 |
GSK Investigational Site | Honolulu, Hawaii, United States, 96813 |
GSK Investigational Site | Idaho Falls, Idaho, United States, 83404 |
GSK Investigational Site | Chicago, Illinois, United States, 60612 |
GSK Investigational Site | O'Fallon, Illinois, United States, 62269 |
GSK Investigational Site | Elkhart, Indiana, United States, 46515 |
GSK Investigational Site | Indianapolis, Indiana, United States, 46260 |
GSK Investigational Site | Iowa City, Iowa, United States, 52242 |
GSK Investigational Site | Kalamazoo, Michigan, United States, 49009 |
GSK Investigational Site | Oak Park, Michigan, United States, 48237 |
GSK Investigational Site | Minneapolis, Minnesota, United States, 55417 |
GSK Investigational Site | Kansas City, Missouri, United States, 64111 |
GSK Investigational Site | Kansas City, Missouri, United States, 64106 |
GSK Investigational Site | St. Louis, Missouri, United States, 63110 |
GSK Investigational Site | St. Louis, Missouri, United States, 63128 |
GSK Investigational Site | Las Vegas, Nevada, United States, 89103 |
GSK Investigational Site | Albuquerque, New Mexico, United States, 87131 |
GSK Investigational Site | Oklahoma City, Oklahoma, United States, 73112 |
GSK Investigational Site | Bend, Oregon, United States, 97701 |
GSK Investigational Site | Oregon City, Oregon, United States, 97045 |
GSK Investigational Site | Dallas, Texas, United States, 75390 |
GSK Investigational Site | Fort Worth, Texas, United States, 76104 |
GSK Investigational Site | Georgetown, Texas, United States, 78626 |
GSK Investigational Site | Midland, Texas, United States, 79705 |
GSK Investigational Site | San Antonio, Texas, United States, 78299 |
GSK Investigational Site | San Antonio, Texas, United States, 78259 |
GSK Investigational Site | The Colony, Texas, United States, 75056 |
GSK Investigational Site | Ogden, Utah, United States, 84401 |
GSK Investigational Site | Renton, Washington, United States, 98055 |
GSK Investigational Site | Madison, Wisconsin, United States, 53792 |
GSK Investigational Site | Milwaukee, Wisconsin, United States, 53151 |