Table 5

Pioglitazone placebo-controlled trials: Study and population characteristics

StudyPioglitazone dosage Combination therapySample size intervention groupSample size placebo groupFollow-upaMean age (SD) Gender Other population characteristicsaBaseline mean Weight (SD) BMI (SD) A1c (SD)Quality Funder
Aronoff 2000817.5, 15, 30, 45 mg daily

Monotherapy
3207926 wk53.7 (NR) yr
42% female (data for all groups combined)
90.4 (13.1) kg
NR
10.4% (2.0%)
Poor
Takeda
Belfort 20068245 mg daily

Both groups: 500 kcal/d deficit diet
262126 wk51 (10) yr
55% female
Participants had IGT or DM2 and NASH
90.2 (15.4) kg
32.9 (4.4) kg/m2
6.2% (1.1%)
Fair
National Center for Research Resources, Takeda, VA Medical Research Fund
Dormandy 200560, Charbonnel 200583

PROActive Study
Titrated up to 45 mg daily

Combined with various hypoglycemic agents
26052633156 wk (mean 34.5 mo)61.6 (7.8) yr
34% female
All subject had evidence of macrovascular disease
NR
31.0 (4.8) kg/m2
7.9% (NR)
Good
Takeda and Eli Lilly and Company
Gastadelli 20078445 mg daily

Combined with various SU

Study had another arm with randomization to rosiglitazone or placebo
101016 wk55 (13) yr
30% female
NR 29.9
(4.4) kg/m2
8.3% (1.3%)
Poor
Takeda, GlaxoSmithKline, NIH, Veterans Administration Merit Award
Herz 20038530, 45 mg daily

Monotherapy
999916 wk58.0 (10.7) yr
51% female
All subjects had controlled DM2 on diet only
86.3 (17.4) kg
31.7 (4.5) kg/m2
7.5% (NR)
Fair
Eli Lilly
Kipnes 20018615, 30 mg daily

Added to SU
184+18918716 wk56.8 (8.9) yr
42% female
NR
32.0 (4.9) kg/m2
9.9% (1.4%)
Fair
Takeda
Mattoo 20058730 mg daily

Combined with insulin
14214726 wk58.8 (7.4) yr
57% female
All subjects were using insulin for ≥3m
NR
32.5 (4.8) kg/m2
8.9% (1.3%)
Fair
Eli Lilly and Takeda
McMahon 20058845 mg daily

Combined with insulin
8812 wk52.5 (NR) yr
11% female
Using insulin
NR
32.3 (4.1) kg/m2
7.7% (0.6%)
Poor
Takeda, American Heart Association, NHLBI
Miyazaki 2002777.5, 15 mg daily

Monotherapy
471126 wk58.0 (9.9) yr
73% female
90 (13.3) kg
32.8 (5.3) kg/m2
8.6% (1.7%)
Fair
Takeda
Miyazaki 200189 200490

Gastaldelli 200691
45 mg daily

Added to SU
121116 wk55 (13.3) yr

45% female
Generally healthy
82 (16.6) kg
30 (3.3) kg/m2
8.2% (1.0%)
Data from 2004 (2001 baseline data slightly different)
Poor
Takeda (in part)
Gastaldelli 2006 funded by and NIH grant and a Veterans Administration Merit Award
Negro 20049245 mg daily

Added to metformin
20208 wk61.9 (6.0) yr
NR
NR
26.7 (2.4) kg/m2
7.7% (0.6%)
Poor
NR
NIshio 20069330 mg daily starting 2w after stent placement

Monotherapy Control group no treatment
262826 wk67.5 (10.3) yr
28% female
All subjets had acute coronary syndrome and received coronary stenting
NR
24.6 (3.5) kg/m2
6.9% (1.6%)
Poor
NR
Rosenblatt 20019430 mg daily

Monotherapy
1019616 wk55.2 (10.0) yr
44% female
87.2 kg (18.4)
30.7 (5.0) kg/m2
10.4% (1.7%)
Fair
Takeda
Rosenstock 20029515, 30 mg daily

Monotherapy
37918716 wk56.7 (9.4) yr
55% female
All subjects were using insulin
95.4 (17) kg
33.2 (5.2) kg/m2
9.8% (0.1%)
Fair
Takeda
Saad 20047645 mg daily

Monotherapy
1473012 wk54 (NR) yr
40% female
NR
31 (NR) kg/m2
8.1% (NR)
Fair
Funding NR; 1 author affiliation Novo-Nordisk Pharmaceuticals, Princeton, NJ
Scherbaum 20029615, 30 mg daily

Monotherapy
76+837626 wk59.1 (NR) yr
44% female
84.8 (NR) kg
29.2 (NR) kg/m2
8.8% (1.1%)
Poor
Takeda, Europe
Smith 200497
Bogacka 200498
45 mg daily

Monotherapy
212124 wk53.1 (9.3) yr
53% female
91.5 (14.9) kg
31.9 (5.0) kg/m2
6.5% (0.7%)
Poor
Takeda USA
Sourij 200630 mg daily

Monotherapy
212112 wk60.3 (7.5) yr
7.1% female
All subjects had newly-detected DM2 with CAD
NR
28.2 (4.1) kg/m2
6.1% (0.5%)
Poor
Takeda Austria
Takagi T 20037830 mg daily

Combined with various treatments
232126 wk65 (9) yr
50% female
Known CAD
NR
24.5 (NR) kg
(2.9) (NR) kg/m2
6.7% (1.2%)
Poor
NR
Tseng C-H 20059930 mg daily

Combined with SU
232512 wk54.1 (14.9) yr
65% female
All subjects were using SU
62.6 (13.3) kg
NR
NR
Fair-poor
NR
Wallace 200410045 mg daily

Monotherapy
191112 wk62.6 (10) yr
27% female
All subject were diet-controlled DM2
85.2 (4.3) kg
28.9 (2.8) kg/m2
6.7% (0.9%)
Fair
Takeda UK
Summary7.5 to 45 mg daily10 to 260510 to 26338 to 156 wk51.0–67.5 yr
7.1–73% female
62.6 to 90.4 kg
24.5 to 33.2 kg/m2
Good: 1
Fair: 10
Poor: 10

Abbreviations: BMI, body mass index; CAD, coronary artery disease; DM2, type 2 diabetes mellitus; IGT, impaired glucose tolerance; mo, month; NASH, nonalcoholic steatohepatitis; NR, not reported; SD, standard deviation; SU, sulfonylurea; wk, week(s); yr, year(s).

a

Baseline mean values are given for the control group. Standard deviation is given in parentheses ( ). If standard error was provided in the original study, we 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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