Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
Overview[ - collapse ][ - ]
| Purpose | Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure |
|---|---|
| Condition | Hypertension |
| Intervention | Drug: carvedilol Drug: metoprolol |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00060931 |
| First Received | May 15, 2003 |
| Last Updated | April 11, 2013 |
| Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2003 |
|---|---|
| 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 levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. [Time Frame: 5 months] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension |
|---|---|
| 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. |
| Brief Summary | Evaluation of the effect of two different antihypertensive treatments 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 |
|---|---|
| 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). - 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. |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00060931 |
|---|---|
| Other Study ID Numbers | 105517/347 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | August 2012 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Birmingham, Alabama, United States, 35294-0012 |
|---|---|
| GSK Investigational Site | Birmingham, Alabama, United States, 35294-2041 |
| GSK Investigational Site | Columbia, Alabama, United States, 35051 |
| GSK Investigational Site | Mobile, Alabama, United States, 36608 |
| GSK Investigational Site | Newark, Delaware, United States, 19713 |
| GSK Investigational Site | Washington, District of Columbia, United States, 20422 |
| GSK Investigational Site | Washington, District of Columbia, United States, 20037 |
| GSK Investigational Site | Coral Gables, Florida, United States, 33134 |
| GSK Investigational Site | Fort Lauderdale, Florida, United States, 33316 |
| GSK Investigational Site | Gainesville, Florida, United States, 32605 |
| GSK Investigational Site | Hollywood, Florida, United States, 33021 |
| GSK Investigational Site | Hollywood, Florida, United States, 33023 |
| GSK Investigational Site | Melbourne, Florida, United States, 32901 |
| GSK Investigational Site | Miami, Florida, United States, 33133 |
| GSK Investigational Site | Miami, Florida, United States, 33136 |
| GSK Investigational Site | Ocala, Florida, United States, 34474 |
| GSK Investigational Site | Saint Petersberg, Florida, United States, 33705 |
| GSK Investigational Site | Sarasota, Florida, United States, 34239 |
| GSK Investigational Site | Tamarac, Florida, United States, 33321 |
| GSK Investigational Site | Tampa, Florida, United States, 33614 |
| GSK Investigational Site | Fayetteville, Georgia, United States, 30214 |
| GSK Investigational Site | Savannah, Georgia, United States, 31406 |
| GSK Investigational Site | Chicago, Illinois, United States, 60616 |
| GSK Investigational Site | Newburgh, Indiana, United States, 47630 |
| GSK Investigational Site | Wabash, Indiana, United States, 46992 |
| GSK Investigational Site | New Orleans, Louisiana, United States, 70112 |
| GSK Investigational Site | Auburn, Maine, United States, 04210 |
| GSK Investigational Site | Ayer, Massachusetts, United States, 01432 |
| GSK Investigational Site | Waltham, Massachusetts, United States, 02453 |
| GSK Investigational Site | Waterford, Michigan, United States, 48328 |
| GSK Investigational Site | Gulfport, Mississippi, United States, 39501 |
| GSK Investigational Site | Flushing, New York, United States, 11365 |
| GSK Investigational Site | Kingston, New York, United States, 12401 |
| GSK Investigational Site | New York, New York, United States, 10032 |
| GSK Investigational Site | New York, New York, United States, 10021 |
| GSK Investigational Site | Tonawanda, New York, United States, 14150 |
| GSK Investigational Site | Williamsville, New York, United States, 14221 |
| GSK Investigational Site | Wilmington, North Carolina, United States, 28412 |
| GSK Investigational Site | Canton, Ohio, United States, 44708 |
| GSK Investigational Site | Cincinnati, Ohio, United States, 45246 |
| GSK Investigational Site | Cleveland, Ohio, United States, 44106 |
| GSK Investigational Site | Columbus, Ohio, United States, 43212 |
| GSK Investigational Site | Camp Hill, Pennsylvania, United States, 17011 |
| GSK Investigational Site | Connellsville, Pennsylvania, United States, 15425 |
| GSK Investigational Site | Erie, Pennsylvania, United States, 16505 |
| GSK Investigational Site | Morrisville, Pennsylvania, United States, 19067 |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States, 19107 |
| GSK Investigational Site | Bristol, Tennessee, United States, 37620 |
| GSK Investigational Site | Jackson, Tennessee, United States, 38301 |
| GSK Investigational Site | Nashville, Tennessee, United States, 37212 |
| GSK Investigational Site | White River Junction, Utah, United States, 05009 |
| GSK Investigational Site | Salem, Virginia, United States, 24153 |