Table 7

Rosiglitazone placebo-controlled trials: Study and population characteristics

StudyRosiglitazone dosage Combination therapySample size intervent ion group(s)Sample size placebo groupFollow -upaMean age (SD) Gender Other population characteristicsaBaseline mean weight (SD) BMI (SD) A1c (SD)Quality Funder
Agrawal 20031124 mg daily, 2 mg twice daily

Combined with Various SU
26026326 wk61.6 (NR) yr
38% female
Normal renal function (see subgroups for renal-impaired)
NR
30.7 (NR) kg/m2
9.2% (NR)
Fair (based on secondary data)
Funder NR
Barnett 20031134 mg twice daily

combined with various SU
848726 wk54.2 (NR) yr
22% female
Participants
Indian 60%
Pakistani 27%
NR
26.4 (NR) kg/m2
9.1% (NR)
Fair
SmithKline Beecham Pharmaceuticals
Dailey 20041054–8 mg daily

Both groups: glyburide/metfo rmin 1.5/500 to 10/2000 mg daily
18118424 wk57 (10) yr
39% female
Inadequately controlled on an oral agent
93 (18) kg
32 (5) kg/m2
8.1% (0.8%)
Fair
Bristol-Myers
Squibb Research Institute, Princeton New Jersey
Dargie 2007564–8 mg daily

Combined with various other hypoglycemic agents (not insulin or metformin)
11011452 wk63.9 (8.6) yr
20.9 % female
NYHA functional class I to II CHF with LVEF ≤ 45%
84.3 (14.3) kg
28.6 (3.5) kg/m2
7.8% (1.3%)
Fair
GlaxoSmithKline
Fonseca 20001144,8 mg daily

Combined with metformin
22611326 wk58 (NR) yr
32 % female
NR
30.3 (4.4) kg/m2
8.6% (1.3%)
Fair
SmithKline
Beecham Pharmaceuticals
Gastaldelli 2007848 mg daily

Monotherapy (SU withdrawn) Study has another arm with randomization to pioglitazone or placebo
121216 wk55(10) yr
50 % female
NR
29.8 (4.2) kg/m2
8.1% (1.9%)
Poor
Takeda
Pharmaceuticals, GlaxoSmithKline, NIH, Veterans Administration Merit Award
Gomez- Perez 20021152 mg twice daily, 4 mg twice daily

Combined with metformin
713426 wk53.1 (NR) yr
74 % female
NR
28.5 (3.9) kg/m2
9.8% (NR)
Fair
Funder NR; 3 authors (including corresponding author) from GlaxoSmithKline
Hallsten 20021164 mg twice daily

Monotherapy
141426 wk58.0 (NR) yr
32 % female
Without complications
88.3 (9.4) kg
NR
6.3% (0.4%)
Fair
Academy of Finland, Novo Nordisk Foundation, Finnish Diabetes Research Society, and GlaxoSmithKline
Honisett 20031014 mg daily

Monotherapy
211012 wkNR
100 % female
Postmenopaus al women
NR
NR
7.6% (3.2%) (Rosi group)
Poor
Funder NR
Iozzo 20031178 mg daily

Monotherapy
91026 wk58 (NR) yr
33 % female
No prior pharmacotherapy for DM2
NR
31.5 (4.7) kg/m2
6.1% (0.7%)
Fair
GlaxoSmithKline
Jones 20031184,8 mg daily

Combined with metformin
80+449326 wk59.9 (NR) yr
32 % female
BMI 25–30 (obese presented in subgroups)
NR
27.7 (1.4) kg/m2
8.8% (1.4%)
Fair
Funder NR; 3 of 4 authors from GlaxoSmithKline
Kim 20051194 mg daily

Monotherapy
606012 wk58.4 (9.1) yr
65% female
Taking metformin or SU
62.3 (11.0) kg
24.5 (3.0) kg/m2
9.3% (1.3%)
Fair
National R&D program, Ministry of Science Technology, Republic of Korea
Lautamaki 20051064,8 mg daily

Combined with metformin or SU
272716 wk63.2 (7.4) yr
30 % female
Known coronary artery disease
89.1 (14.3) kg
26.9 (3.4) kg/m2
7.1% (0.9%)
Fair
Academy of Finland, Turku University Hospital, GlaxoSmithKline
Lebovitz HE 20011204,8 mg daily

Monotherapy
169+16615826 wk60 (NR) yr
34% female
NR
29.9 (4.1) kg/m2
9.0% (1.7%)
Poor
Funder NR; 5 of 6 authors from SmithKline Beecham Pharmaceuticals
Miyazaki 20011218 mg daily

Monotherapy
151412 wk56 (2) yr
36 % female
87.0 (18.7)kg
30.1 (3.7) kg/m2
8.3% (1.5%)
Fair
SmithKline Beecham
Natali 20041228 mg daily

Monotherapy
22248 wk58 (9) yr
18% female
NR
30.2 (3.1) kg/m2
7.6% (0.8%)
Fair
GlaxoSmithKline
Negro 20051074 mg twice daily

Metformin up to 2550 mg daily
191952 wk59 (8) yr
37% female
Blood pressure non dippers
83.6 (4.4) kg
28.7 (1.9) kg/m2
8.1% (0.5%)
Poor
GlaxoSmithKline
Osman 20041084–8 mg daily

Combined with other oral agents or insulin continued
8826 wk57.3 (NR) yr
38% female
Referred for coronary stenting
NR
NR
8.7% (1.9%)
Poor
Funded in part by NIH
Nolan 20001044,8,12, mg daily

Monotherapy
276938 wk62.8 (9.5) yr
39% female
81.3 (14.5) kg
29.6 (4.4) kg/m2
NR
Fair
Funder NR; 3 of 4 authors from SmithKline Beecham Pharmaceuticals
Patel 19991230.05, 0.25, 1.0, 2.0 mg twice daily

Monotherapy
74+72+7
9
+90
7412 wk56.8 (11.5) yr
31% female
NR
29.1 (4.2) kg/m2
8.9% (1.5%)
Fair
Funder NR; authors from SmithKline Beecham and VA
Phillips 20011242 mg twice daily, 4 mg daily, 4 mg twice daily, 8 mg daily

Monotherapy
73517326 wk56.8 (9.2) yr
31% female
NR
29.1 (4.2) kg/m2
8.9% (1.5%)
Fair
Funder NR, author affiliations include SmithKline Beecham Pharmaceuticals, USA
Pfutzner 2006111
Hammann 2003
4, 8 mg daily

Combined with glimepiride 3 mg daily
31+413116 wk63.7 (9.0) yr
50% female
NR
30.0 (3.4) kg/m2
7.7% (1.4%)
Fair
GlaxoSmithKline, Munich, Germany
Raskin 20001022,3,6 mg, twice daily215698 wk60.1 (9.4) yr
40.6 % female
NR
30.4 (4.2) kg/m2
0.087% (0.0163%) (reference range <0.065)
Fair
Funder NR; 5 of 6 authors from SmithKline Beecham Pharmaceuticals
Raskin 2001252, 4 mg twice daily

Combined with insulin
103+10610426 wk55.6 (10.3) yr
44 % female
NR
32.7 (4.5) kg/m2
8.9% (1.1%)
Good
Funder NR
Individual authors have received support from SmithKline Beecham
Reynolds 20021264 mg daily

Combined with insulin
111024 wkNR
NR
BMI>27
108.0 (29) kg
36.3 (2.5) kg/m2
9.8% (1.6%)
Poor
Health management Resources and GlaxoSmithKline
Rosenstoc k 2006110

RESULT Study
4 mg daily

Combined with glipizide 10 mg twice daily
116111104 wk68.2 (6.3) yr
28.2% female
NR
30.5 (4.9) kg/m2
7.7% (1.0%)
Fair-poor
NR; data analysis and some coauthors from GlaxoSmithKline
Tan 2005(a)1274 mg twice daily

Monotherapy
121212 wk52.3 (10.1) yr
46% female
No prior pharmacotherapy for DM2
NR
32.8 (4.9) kg/m2
7.5% (1.0%)
Fair
GlaxoSmithKline
Van Wijk 20051284 mg twice daily

Monotherapy
19 (cross- over)19 (cross- over)8 wk60 (NR) yr
26% female
NR
29.2 (4.8) kg/m2
6.2% (0.9%)
Fair
GlaxoSmithKline
Virtanen 20031294 mg twice daily

Monotherapy
141426 wk58 (7.5) yr
40 % female
88.3 (9.7) kg
30.7 (4.9) kg/m2
6.3% (0.4%)
Fair
Academy of Finland, Novo Nordisk Foundation, Finnish Diabetes Research Society, GlaxoSmithKline
Wang 20051034 mg daily

Monotherapy
353526 wk62.2 (8.6) yr
20% female
Coronary artery disease; recent percutaneous coronary intervention
NR
25.6 (2.7) kg/m2
7.33% (0.17%)
Fair
Major National Basic Research Program of PR China and Chinese National Natural Science Foundation
Wolffenbu ttel 20001301,2 mg twice daily

Combined with various SU
183+19919226 wk61.9 (9.1) yr
43% female
Using SU for >6m
NR
28.1 (4.1) kg/m2
9.2% (1.3%)
Fair
Funder NR 1 of 5 authors from SmithKline Beecham
Yang 20021314 mg daily

Combined with various SU
303426 wk57.8 (8.9) yr
61.8% female
65.3 (11.2) kg
25.8 (3.5) kg/m2
9.7% (1.4%)
Fair
Smith-Kline Beecham Pharmaceuticals and a grant from the Department of Education of the Republic of China
Zhu 20031322,4 mg twice daily

Combined with various SU
42510524 wk58.9 (7.7) yr
54% female
Chinese, no hepatic impairment
NR
25.1(2.8) kg/m2
9.8% (1.3%)
Fair
SmithKline Beecham Research and Development
Range1 to 12 mg daily8 to 73510 to 2638 to 104 wk52.3 to 63.9 yr 18% to 100% female62.3 to 93.0 kg 24.5 to 36.3 kg/m2Good: 1
Fair: 25
Poor: 6

Abbreviations: BMI, body mass index, kg/m2; CHF, congestive heart failure; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; NR, not reported; SU, sulfonylurea; m, months; DM2, type 2 diabetes mellitus; wk, week(s); yr, year(s).

a

Baseline values are given for the control group.

If standard error was provided in the original study, we have converted standard error to standard deviation.

From: Results

Cover of Drug Class Review: Thiazolidinediones
Drug Class Review: Thiazolidinediones: Final Report Update 1 [Internet].
Norris SL, Carson S, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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