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Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00499707
Collaborator
(none)
453
Enrollment
102
Locations
14.3
Duration (Months)
4.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.

Condition or Disease Intervention/Treatment Phase
  • Drug: rosiglitazone maleate/metformin hydrochloride
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
453 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
Study Start Date :
Oct 8, 2003
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 16, 2004

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in hemoglobin A1c (HbA1c) at week 32. [at 32 week]

Secondary Outcome Measures

  1. Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks [at 32 weeksInvalid value]

Eligibility Criteria

Criteria

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

  • 18 to 70 years of age

  • Clinical diagnosis of type 2 diabetes

  • HbA1c >7.5% to 11%

  • FPG <270mg/dL (15mmol)

  • Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening

Exclusion Criteria:

  • Clinically significant renal or hepatic disease

  • Presence of anemia

  • Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy

  • Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment

  • Chronic disease requiring intermittent or chronic treatment with corticosteroids

  • Any female lactating, pregnant, or planning to become pregnant

  • History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione

  • Presence of acute or chronic metabolic acidosis

  • History of diabetic ketoacidosis

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 30342
16 GSK Investigational Site Fayetteville Georgia United States 30214
17 GSK Investigational Site Woodstock Georgia United States 30189
18 GSK Investigational Site Chicago Illinois United States 60607
19 GSK Investigational Site Evansville Indiana United States 47713
20 GSK Investigational Site Newburgh Indiana United States 47630
21 GSK Investigational Site Slidell Louisiana United States 70461
22 GSK Investigational Site Jackson Mississippi United States 39202
23 GSK Investigational Site Chesterfield Missouri United States 63017
24 GSK Investigational Site Kansas City Missouri United States 64111
25 GSK Investigational Site Saint Louis Missouri United States 63376
26 GSK Investigational Site Las Vegas Nevada United States 89103
27 GSK Investigational Site Kingston New York United States 12401
28 GSK Investigational Site New York New York United States 10024
29 GSK Investigational Site New York New York United States 10029
30 GSK Investigational Site New York New York United States 10032
31 GSK Investigational Site Rochester New York United States 14609
32 GSK Investigational Site Charlotte North Carolina United States 28210
33 GSK Investigational Site Mogadore Ohio United States 44260
34 GSK Investigational Site Downingtown Pennsylvania United States 19335
35 GSK Investigational Site Warminster Pennsylvania United States 18974
36 GSK Investigational Site West Chester Pennsylvania United States 19382
37 GSK Investigational Site Bristol Tennessee United States 37620
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 Dallas Texas United States 75230
43 GSK Investigational Site Midland Texas United States 79705
44 GSK Investigational Site San Antonio Texas United States 78221
45 GSK Investigational Site San Antonio Texas United States 78237
46 GSK Investigational Site Seattle Washington United States 98108
47 GSK Investigational Site Spokane Washington United States 99207
48 GSK Investigational Site Wenatchee Washington United States 98801
49 GSK Investigational Site Camperdown New South Wales Australia 2050
50 GSK Investigational Site St Leonards New South Wales Australia 2065
51 GSK Investigational Site Wollongong New South Wales Australia 2500
52 GSK Investigational Site Kippa Ring Queensland Australia 4021
53 GSK Investigational Site Woolloongabba Queensland Australia 4102
54 GSK Investigational Site North Adelaide South Australia Australia 5006
55 GSK Investigational Site Caulfield Victoria Australia 3162
56 GSK Investigational Site Fremantle Western Australia Australia 6959
57 GSK Investigational Site Perth Western Australia Australia 6000
58 GSK Investigational Site Recife Pernambuco Brazil 50100-130
59 GSK Investigational Site São Paulo Brazil 04020-041
60 GSK Investigational Site Calgary Alberta Canada T3E 0C5
61 GSK Investigational Site Coquitlam British Columbia Canada V3K 3V9
62 GSK Investigational Site Langley British Columbia Canada V3A 4H9
63 GSK Investigational Site Moncton New Brunswick Canada E1G 1A7
64 GSK Investigational Site Halifax Nova Scotia Canada B3K 5R3
65 GSK Investigational Site Brampton Ontario Canada L6T 3T1
66 GSK Investigational Site Burlington Ontario Canada L7M 4Y1
67 GSK Investigational Site Courtice Ontario Canada L1E 3C3
68 GSK Investigational Site Kitchener Ontario Canada N2C 2N9
69 GSK Investigational Site North Bay Ontario Canada P1B 2H3
70 GSK Investigational Site Oshawa Ontario Canada L1H 1C2
71 GSK Investigational Site Peterborough Ontario Canada K9H 5G1
72 GSK Investigational Site Peterborough Ontario Canada K9J 7B3
73 GSK Investigational Site Renfrew Ontario Canada K7V 1P6
74 GSK Investigational Site Stoney Creek Ontario Canada L8G 2V6
75 GSK Investigational Site Toronto Ontario Canada M3J 1N2
76 GSK Investigational Site Laval Quebec Canada H7T 2P5
77 GSK Investigational Site Montreal Quebec Canada H1V 1X4
78 GSK Investigational Site Montreal Quebec Canada H3S 2W1
79 GSK Investigational Site Montreal Quebec Canada H4N 2W2
80 GSK Investigational Site Plessisville Quebec Canada G6L 3J1
81 GSK Investigational Site Pointe-Claire Quebec Canada H9R 4S3
82 GSK Investigational Site Saint Insidore De Dorchester Quebec Canada G0S 2S0
83 GSK Investigational Site Saint Marc Des Carrieres Quebec Canada G0A 4B0
84 GSK Investigational Site Sainte Jerome Quebec Canada J7Z 5T3
85 GSK Investigational Site Sherbrooke Quebec Canada J1H 1Z1
86 GSK Investigational Site Regina Saskatchewan Canada S4S 0A2
87 GSK Investigational Site Regina Saskatchewan Canada S4S 3R8
88 GSK Investigational Site Saskatoon Saskatchewan Canada S7K 0M5
89 GSK Investigational Site Pusan Korea, Republic of 602-739
90 GSK Investigational Site Seoul Korea, Republic of 139-872
91 GSK Investigational Site Uijeongbu, Korea, Republic of 480-821
92 GSK Investigational Site Tijuana Baja California Norte Mexico 22320
93 GSK Investigational Site Guadalajara Jalisco Mexico 44340
94 GSK Investigational Site Monterrey Nuevo León Mexico 64570
95 GSK Investigational Site Durango Mexico 3400
96 GSK Investigational Site Mexico, D.F. Mexico 11850
97 GSK Investigational Site Mexico, D.F. Mexico 14050
98 GSK Investigational Site Auckland New Zealand 1311
99 GSK Investigational Site Auckland New Zealand 1701
100 GSK Investigational Site Christchurch New Zealand 8001
101 GSK Investigational Site Rotorua New Zealand 3201
102 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

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00499707
Other Study ID Numbers:
  • 712753/007
First Posted:
Jul 11, 2007
Last Update Posted:
Mar 21, 2018
Last Verified:
Mar 1, 2018
Keywords provided by GlaxoSmithKline
HbA1c
Drug-naive
type 2 diabetes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metformin
Rosiglitazone

Study Results

No Results Posted as of Mar 21, 2018