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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00060918
First received: May 15, 2003
Last updated: April 11, 2013
Last verified: June 2012

May 15, 2003
April 11, 2013
June 2001
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Change from baseline in HbA1c at 5 months [ Time Frame: 5 months ]
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Complete list of historical versions of study NCT00060918 on ClinicalTrials.gov Archive Site
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 ]
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Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
  • Drug: carvedilol
  • Drug: metoprolol
    Other Names:
    • metoprolol
    • carvedilol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1210
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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.
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060918
105517/346
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP