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A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00067951
Collaborator
(none)
190
Enrollment
94
Locations
13.5
Duration (Months)
2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus
Study Start Date :
Oct 17, 2003
Actual Primary Completion Date :
Nov 1, 2004
Actual Study Completion Date :
Nov 30, 2004

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment. []

Secondary Outcome Measures

  1. Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Laboratory result for HbA1c >11% or FPG >270mg/dL

  • Clinical diagnosis of Type II diabetes

  • Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria:
  • Women who are pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Anniston Alabama United States 36207
2 GSK Investigational Site Chandler Arizona United States 85224
3 GSK Investigational Site Phoenix Arizona United States 85014
4 GSK Investigational Site Phoenix Arizona United States 85050
5 GSK Investigational Site Tucson Arizona United States 85745
6 GSK Investigational Site Encinitas California United States 92024
7 GSK Investigational Site Fullerton California United States 92835
8 GSK Investigational Site Los Banos California United States 93635
9 GSK Investigational Site Mission Viejo California United States 92691
10 GSK Investigational Site Jacksonville Florida United States 32204
11 GSK Investigational Site Melbourne Florida United States 32901
12 GSK Investigational Site Miami Florida United States 33156
13 GSK Investigational Site Orlando Florida United States 32806
14 GSK Investigational Site Saint Cloud Florida United States 34769
15 GSK Investigational Site Atlanta Georgia United States 30308
16 GSK Investigational Site Atlanta Georgia United States 30342
17 GSK Investigational Site Fayetteville Georgia United States 30214
18 GSK Investigational Site Woodstock Georgia United States 30189
19 GSK Investigational Site Chicago Illinois United States 60607
20 GSK Investigational Site Evansville Indiana United States 47713
21 GSK Investigational Site Newburgh Indiana United States 47630
22 GSK Investigational Site Slidell Louisiana United States 70461
23 GSK Investigational Site Jackson Mississippi United States 39202
24 GSK Investigational Site Chesterfield Missouri United States 63017
25 GSK Investigational Site Kansas City Missouri United States 64111
26 GSK Investigational Site Saint Louis Missouri United States 63376
27 GSK Investigational Site Las Vegas Nevada United States 89103
28 GSK Investigational Site Kingston New York United States 12401
29 GSK Investigational Site New York New York United States 10024
30 GSK Investigational Site New York New York United States 10029
31 GSK Investigational Site New York New York United States 10032
32 GSK Investigational Site Rochester New York United States 14609
33 GSK Investigational Site Charlotte North Carolina United States 28210
34 GSK Investigational Site Mogadore Ohio United States 44260
35 GSK Investigational Site Downingtown Pennsylvania United States 19335
36 GSK Investigational Site Warminster Pennsylvania United States 18974
37 GSK Investigational Site West Chester Pennsylvania United States 19382
38 GSK Investigational Site Johnson City Tennessee United States 37601
39 GSK Investigational Site Arlington Texas United States 76017
40 GSK Investigational Site Beaumont Texas United States 77701
41 GSK Investigational Site Bryan Texas United States 77802
42 GSK Investigational Site Corpus Christi Texas United States 78411
43 GSK Investigational Site Dallas Texas United States 75230
44 GSK Investigational Site Midland Texas United States 79705
45 GSK Investigational Site San Antonio Texas United States 78221
46 GSK Investigational Site San Antonio Texas United States 78237
47 GSK Investigational Site Seattle Washington United States 98108
48 GSK Investigational Site Spokane Washington United States 99207
49 GSK Investigational Site Wenatchee Washington United States 98801
50 GSK Investigational Site Camperdown New South Wales Australia 2050
51 GSK Investigational Site St Leonards New South Wales Australia 2065
52 GSK Investigational Site Wollongong New South Wales Australia 2500
53 GSK Investigational Site Kippa Ring Queensland Australia 4021
54 GSK Investigational Site Woolloongabba Queensland Australia 4102
55 GSK Investigational Site North Adelaide South Australia Australia 5006
56 GSK Investigational Site Caulfield Victoria Australia 3162
57 GSK Investigational Site Fremantle Western Australia Australia 6959
58 GSK Investigational Site Perth Western Australia Australia 6000
59 GSK Investigational Site Calgary Alberta Canada T3E 0C5
60 GSK Investigational Site Coquitlam British Columbia Canada V3K 3V9
61 GSK Investigational Site Langley British Columbia Canada V3A 4H9
62 GSK Investigational Site Moncton New Brunswick Canada E1G 1A7
63 GSK Investigational Site Halifax Nova Scotia Canada B3K 5R3
64 GSK Investigational Site Brampton Ontario Canada L6T 3T1
65 GSK Investigational Site Burlington Ontario Canada L7M 4Y1
66 GSK Investigational Site Courtice Ontario Canada L1E 3C3
67 GSK Investigational Site Kitchener Ontario Canada N2C 2N9
68 GSK Investigational Site North Bay Ontario Canada P1B 2H3
69 GSK Investigational Site Oshawa Ontario Canada L1H 1C2
70 GSK Investigational Site Peterborough Ontario Canada K9H 5G1
71 GSK Investigational Site Peterborough Ontario Canada K9J 7B3
72 GSK Investigational Site Renfrew Ontario Canada K7V 1P6
73 GSK Investigational Site Stoney Creek Ontario Canada L8G 2V6
74 GSK Investigational Site Toronto Ontario Canada M3J 1N2
75 GSK Investigational Site Laval Quebec Canada H7T 2P5
76 GSK Investigational Site Montreal Quebec Canada H1V 1X4
77 GSK Investigational Site Montreal Quebec Canada H3S 2W1
78 GSK Investigational Site Montreal Quebec Canada H4N 2W2
79 GSK Investigational Site Plessisville Quebec Canada G6L 3J1
80 GSK Investigational Site Pointe-Claire Quebec Canada H9R 4S3
81 GSK Investigational Site Saint Insidore De Dorchester Quebec Canada G0S 2S0
82 GSK Investigational Site Saint Marc Des Carrieres Quebec Canada G0A 4B0
83 GSK Investigational Site Sainte Jerome Quebec Canada J7Z 5T3
84 GSK Investigational Site Sherbrooke Quebec Canada J1H 1Z1
85 GSK Investigational Site Regina Saskatchewan Canada S4P 3X1
86 GSK Investigational Site Saskatoon Saskatchewan Canada S7K 0M5
87 GSK Investigational Site Pusan Korea, Republic of 602-739
88 GSK Investigational Site Seoul Korea, Republic of 139-872
89 GSK Investigational Site Uijeongbu, Korea, Republic of 480-821
90 GSK Investigational Site Auckland New Zealand 1311
91 GSK Investigational Site Auckland New Zealand 1701
92 GSK Investigational Site Christchurch New Zealand 8001
93 GSK Investigational Site Rotorua New Zealand 3201
94 GSK Investigational Site Wellington New Zealand 6035

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067951
Other Study ID Numbers:
  • 712753/004
First Posted:
Sep 5, 2003
Last Update Posted:
Mar 21, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Hyperglycemia
HbA1c
Hemoglobin A1c
Type 2 diabetes mellitus
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metformin
Rosiglitazone

Study Results

No Results Posted as of Mar 21, 2018