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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00060931
Collaborator
(none)
501
Enrollment
119
Locations
34
Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
501 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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.
Study Start Date :
Jun 1, 2001
Actual Primary Completion Date :
Apr 1, 2004
Actual Study Completion Date :
Apr 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in HbA1c at 5 months [5 months]

Secondary Outcome Measures

  1. 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. [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Birmingham Alabama United States 35211
2 GSK Investigational Site Birmingham Alabama United States 35294-0012
3 GSK Investigational Site Birmingham Alabama United States 35294-2041
4 GSK Investigational Site Columbia Alabama United States 35051
5 GSK Investigational Site Mobile Alabama United States 36608
6 GSK Investigational Site Derby Connecticut United States 06418
7 GSK Investigational Site Farmington Connecticut United States 06030 - 1410
8 GSK Investigational Site Hartford Connecticut United States 06106
9 GSK Investigational Site New Britain Connecticut United States 06050
10 GSK Investigational Site Newark Delaware United States 19713
11 GSK Investigational Site Washington District of Columbia United States 20037
12 GSK Investigational Site Washington District of Columbia United States 20422
13 GSK Investigational Site Coral Gables Florida United States 33134
14 GSK Investigational Site Fort Lauderdale Florida United States 33308
15 GSK Investigational Site Fort Lauderdale Florida United States 33316
16 GSK Investigational Site Fort Meyers Florida United States 33907
17 GSK Investigational Site Gainesville Florida United States 32605
18 GSK Investigational Site Hollywood Florida United States 33021
19 GSK Investigational Site Hollywood Florida United States 33023
20 GSK Investigational Site Inverness Florida United States 34452
21 GSK Investigational Site Jacksonville Florida United States 32205
22 GSK Investigational Site Jacksonville Florida United States 32216
23 GSK Investigational Site Melbourne Florida United States 32901
24 GSK Investigational Site Miami Florida United States 33133
25 GSK Investigational Site Miami Florida United States 33136
26 GSK Investigational Site Miami Florida United States 33156
27 GSK Investigational Site Miami Florida United States 33176
28 GSK Investigational Site Ocala Florida United States 34471
29 GSK Investigational Site Ocala Florida United States 34474
30 GSK Investigational Site Pembroke Pines Florida United States 33024
31 GSK Investigational Site Saint Petersberg Florida United States 33705
32 GSK Investigational Site Sarasota Florida United States 34239
33 GSK Investigational Site Tamarac Florida United States 33321
34 GSK Investigational Site Tampa Florida United States 33614
35 GSK Investigational Site Augusta Georgia United States 30901
36 GSK Investigational Site Fayetteville Georgia United States 30214
37 GSK Investigational Site Lawrenceville Georgia United States 30045
38 GSK Investigational Site Savannah Georgia United States 31406
39 GSK Investigational Site Chicago Illinois United States 60616
40 GSK Investigational Site West Evanston Illinois United States 60202
41 GSK Investigational Site Newburgh Indiana United States 47630
42 GSK Investigational Site Wabash Indiana United States 46992
43 GSK Investigational Site Lexington Kentucky United States 40508
44 GSK Investigational Site New Orleans Louisiana United States 70112
45 GSK Investigational Site New Orleans Louisiana United States 70121
46 GSK Investigational Site Auburn Maine United States 04210
47 GSK Investigational Site Bangor Maine United States 04401
48 GSK Investigational Site Baltimore Maryland United States 21204
49 GSK Investigational Site Baltimore Maryland United States 21208
50 GSK Investigational Site Ayer Massachusetts United States 01432
51 GSK Investigational Site Boston Massachusetts United States 02115
52 GSK Investigational Site Haverhill Massachusetts United States 01831-2451
53 GSK Investigational Site Springfield Massachusetts United States 01107
54 GSK Investigational Site Waltham Massachusetts United States 02453
55 GSK Investigational Site Worcester Massachusetts United States 01605
56 GSK Investigational Site Worcester Massachusetts United States 01610
57 GSK Investigational Site Waterford Michigan United States 48328
58 GSK Investigational Site Gulfport Mississippi United States 39501
59 GSK Investigational Site Camden New Jersey United States 08103
60 GSK Investigational Site Hackensack New Jersey United States 07601
61 GSK Investigational Site Linwood New Jersey United States 08221
62 GSK Investigational Site Margate New Jersey United States 08402
63 GSK Investigational Site Sea Girt New Jersey United States 08750
64 GSK Investigational Site Voorhees New Jersey United States 08043
65 GSK Investigational Site Bronx New York United States 10461
66 GSK Investigational Site Bronx New York United States 10467
67 GSK Investigational Site Buffalo New York United States 14209
68 GSK Investigational Site Flushing New York United States 11365
69 GSK Investigational Site Fulton New York United States 13069
70 GSK Investigational Site Kingston New York United States 12401
71 GSK Investigational Site Lancaster New York United States 14043
72 GSK Investigational Site Liverpool New York United States 13088
73 GSK Investigational Site New Hyde Park New York United States 11040
74 GSK Investigational Site New York New York United States 10021
75 GSK Investigational Site New York New York United States 10028
76 GSK Investigational Site New York New York United States 10032
77 GSK Investigational Site Rochester New York United States 14609
78 GSK Investigational Site Scarsdale New York United States 10583
79 GSK Investigational Site Syracuse New York United States 13202
80 GSK Investigational Site Tonawanda New York United States 14150
81 GSK Investigational Site Williamsville New York United States 14221
82 GSK Investigational Site Durham North Carolina United States 27710
83 GSK Investigational Site Hickory North Carolina United States 28601
84 GSK Investigational Site Raleigh North Carolina United States 27609
85 GSK Investigational Site Statesville North Carolina United States 28677
86 GSK Investigational Site Wilmington North Carolina United States 28412
87 GSK Investigational Site Winston-Salem North Carolina United States 27103
88 GSK Investigational Site Canton Ohio United States 44708
89 GSK Investigational Site Cincinnati Ohio United States 45246
90 GSK Investigational Site Cleveland Ohio United States 44106
91 GSK Investigational Site Columbus Ohio United States 43212
92 GSK Investigational Site Zanesville Ohio United States 43701
93 GSK Investigational Site Camp Hill Pennsylvania United States 17011
94 GSK Investigational Site Connellsville Pennsylvania United States 15425
95 GSK Investigational Site Downington Pennsylvania United States 19335
96 GSK Investigational Site Erie Pennsylvania United States 16505
97 GSK Investigational Site Fleetwood Pennsylvania United States 19522
98 GSK Investigational Site Morrisville Pennsylvania United States 19067
99 GSK Investigational Site Philadelphia Pennsylvania United States 19104
100 GSK Investigational Site Philadelphia Pennsylvania United States 19107
101 GSK Investigational Site Philipsburgh Pennsylvania United States 16966
102 GSK Investigational Site Pittsburgh Pennsylvania United States 15206
103 GSK Investigational Site Pittsburgh Pennsylvania United States 15241
104 GSK Investigational Site West Grove Pennsylvania United States 19390
105 GSK Investigational Site Columbia South Carolina United States 29201
106 GSK Investigational Site Greer South Carolina United States 29651
107 GSK Investigational Site Summerville South Carolina United States 29485
108 GSK Investigational Site Bristol Tennessee United States 37620
109 GSK Investigational Site Jackson Tennessee United States 38301
110 GSK Investigational Site Memphis Tennessee United States 38163
111 GSK Investigational Site Nashville Tennessee United States 37212
112 GSK Investigational Site White River Junction Utah United States 05009
113 GSK Investigational Site Christiansburg Virginia United States 24073
114 GSK Investigational Site Falls Church Virginia United States 22044
115 GSK Investigational Site Fredericksburg Virginia United States 20401
116 GSK Investigational Site Richmond Virginia United States 23220
117 GSK Investigational Site Richmond Virginia United States 23294
118 GSK Investigational Site Salem Virginia United States 24153
119 GSK Investigational Site Springfield Virginia United States 22151

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00060931
Other Study ID Numbers:
  • 105517/347
First Posted:
May 16, 2003
Last Update Posted:
Apr 14, 2015
Last Verified:
Apr 1, 2015
Keywords provided by GlaxoSmithKline
hypertension
beta-blockers
Type 2 diabetes
Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus, Type 2
Metoprolol
Carvedilol

Study Results

No Results Posted as of Apr 14, 2015