Table 9

Pioglitazone active-control trials: Study and population characteristics

StudyDosage

Combination therapy
Sample size intervention groupSample size placebo groupFollow-upaMean age (SD) Gender Other population characteristicsaBaseline mean Weight (SD) BMI (SD) A1c (SD)Quality Funder
Agarwal 2005133Glipizide: start 5 mg daily; mean maximal dosage 41 mg daily Pio: start 15 mg daily, mean maximal dosage 19 mg daily

Combined with various oral hypoglycemic agents or insulin
222216 wk67 (8.5) yr
0% female
% on insulin at baseline:
68 (59% in glipizide group)
100% with overt diabetic nephropathy
97.5 (6.0) kg
32.2 (6.0) kg/m2
7.7% (2.2%)
Fair (open label)
Takeda Pharmaceuticals North America, Inc.
Basu 2006134Glipizide: 10 mg daily (median dose)
Pio: 45 mg daily

Monotherapy
81112 wk56 (2) yr
33% female
92 (SE 7) kg
32 (SE 2) kg/m2
6.9% (SE 3)
Fair
Takeda Pharmaceuticals
Heliovaara 2007135Pio 30–45 mg daily
Glibenclamide 1.75–10.5 mg daily

Monotherapy
293052 wk57.2 (SE 1.8) yr
30% female
Failed diet or monotherapy
NR
30.5 (SE 0.9) kg/m2
8.35% (SE 0.12)
Poor
Funder NR Several authors from Eli Lilly and Co.
Jain 2006136Pioglitazone 15–45 mg daily
Glyburide 5–15 mg daily

Monotherapy
25125156 wk52.1 (12.4) yr
44% female
Newly-diagnosed type 2 diabetes; failed diet and exercise therapy
94.3 (20.0) kg
32.8 (5.7) kg/m2
9.2% (1.3%)
Poor
Takeda Pharmaceuticals North America, Inc.
Mazzone 2006137Pio 15–45 mg daily
Glimepiride 1–4 mg daily

Add-on metformin or insulin as needed (12%–13% took insulin during study)
23022872 wk59.9 (8.2) yr
37% female
Newly diagnosed on any therapy
NR
31.9 (5.0) kg/m2
7.4% (1.0%)
Fair
Takeda Pharmaceuticals, North America Inc.
Perriello 2006138Pio 30–45 mg daily
Gliclazide 80–320 mg daily

Appears to be monotherapy (some patients on 1 oral agent prior to study)
14613752 wk59 (assume SD 7) yr
36% female
A1c>7.5%
78.8 (assume SD 10.7) kg
28.8 (assume SD 2.8) kg/m2
8.7% (assume SD 0.9%)
Fair
Funder NR
Oone author was Medical Director Takeda, Italy
Pfutzner 2005111Pio 24 mg daily
Glimepiride 1–6 mg daily

Other oral agents permitted in both groups, except metformin with pio and TZDs with glimepiride
928726 wk63.0 (7.4) yr
38% female
Failed various oral agents; no prior TZD use
NR
31.8 (4.3) kg/m2
7.44% (0.89%)
Fair
Takeda Pharma GmbH, Aachen, Germany
Sharma 2006139Pio 15–30 mg daily
Metformin 1000–2000 mg daily
Gliclazide 30–60 mg daily added to both arms if needed
171812 wk47.7 (9.5) yr
33% female
Newly diagnosed type 2 diabetes
70.7 (9.9) kg
28.6 (3.9) kg/m2
8.03% (0.9%)
Fair
Funder NR
Teramoto 2007140Pio 15–30 mg daily
Glibenclamide 1.25–2.5 mg daily

Monotherapy
464624 wk56.4 (10.5) yr
24% female
Triglycerides 150–500 mg/dl
67.7 (14.5) kg
25.2 (4.8) kg/m2
8.36% (1.29%)
Fair
Japan Pioglitazone Study Group
Umpierrez 2006141Pio 30–45 mg daily
Glimepiride 2–8 mg daily

Add-on to metformin therapy
10910126 wk51.6 (11.8) yr
45% female
Inadequately controlled on metformin monotherapy
NR
34.5 (6.7) kg/m2
8.4% (0.7)%
Fair
Sanofi-Aventis, Bridgewater, New Jersey
Yamanouchi 2005142Pioglitazone 30–45 mg daily
Metformin 750 mg daily
Glimepiride 1.0–2.0 mg daily

Monotherapy
38Metformin: 39
Glimepiride: 37
52 wkMetformin group:
54.7 (9.8) yr
49% female
Japanese subjects
Not on oral agents previously
Metformin group:
NR
26.2 (3.8) kg/m2
9.9% (0.7)%
Fair
Funder NR
Range15–45 mg daily8–25111–25112–72 wk47.7–67.0 yr
0–49% female
67.7–97.5 kg
25.2–34.5 kg/m2
7.4%–9.9%
9 Fair
2 Poor

Abbreviations: BMI, body mass index.; NR, not reported; pio, pioglitazone; SD, standard deviation; SE, standard error; TZD, thiazolidinedione.

a

Baseline data are from the comparison group. Data shown are mean (SD) unless otherwise indicated.

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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