Table 10

Pioglitazone active-control studies: Change in A1c

StudyFollow- up (weeks)TreatmentsA1c baseline pioglitazone group (SD)A1c at follow-up pioglitazone group (SD)A1c baseline comparison group (SD)A1c at follow- up, comparison group (SD)A1c between- group difference (pioglitazone – compared drug (95% CI)Between- group P value
Agarwal 200516Glipizide start 5 mg daily, mean maximal dosage 41 mg daily.
Pioglitazone start 15 mg daily, mean maximal dosage 19 mg daily.
7.2% (1.4)7.1% (1.3%)
Change: −0.1% (1.2%)
7.7% (2.5%)7.3% (1.8%)
Change −0.4% (1.8%)
0.3% (−0.76 to 1.3)0.52
Basu 200612Glipizide 10 mg daily (median dose)
Pioglitazone
45 mg daily

Monotherapy
6.9% (SE 0.3)7.5% (SE 0.8)
Change: 0.6%
6.5% (SE 0.3)6.9% (SE 0.8)
Change 0.4%
0.2% (NR)P>0.05
Heliovaara 200752Pioglitazone
30–45 mg daily
Glibenclamide
1.75–10.5 mg daily
Monotherapy
8.2% (SE 0.1)7.6% (SE 0.2)
P<0.05
8.4% (SE 0.1)7.8% (SE 0.2)
P<0.001
0 (NR)NR
Jain 200656Pioglitazone
15–45 mg daily
Glyburide
5–15 mg daily
Monotherapy
9.2% (1.2%)Change: −2.07%9.2% (1.3%)Change: −2.02%−0.05%0.669
Mazzone 200618 monthsPioglitazone
15–45 mg daily
Glimepiride
1–4 mg daily

Add-on metformin or insulin as needed (12–13% took insulin during study)
7.43% (0.99%)Change at week 72 (from graph):
−0.35%
7.40% (0.97%)Change week
72 (from graph): 0
Week 72: − 0.32% (95% CI −0.52 to −0.12)Week 72:
0.002
Perriello 200652Pioglitazone
30–45 mg daily
Gliclazide
80–320 mg daily
Appears to be monotherapy (some patients on 1 oral agent prior to study)
8.77% (0.81%) (unclear if SD or SE)7.98% (1.4%)8.67% (0.9%)7.88% (1.2%)0 (NR)P>0.05
Pfutzner 200526Pioglitazone
24 mg daily
Glimepiride
1–6 mg daily
Other oral agents permitted in both groups except metformin in the pioglitazone group and thiazolidinediones in the glimepiride group
7.52% (0.85%) (assumed SD)6.71% (0.89%)
Change: −0.8% (0.9%)
P<0.001
7.44% (0.89)
P<0.001
6.83% (0.85)
Change: −0.6% (0.8%)
P<0.001
0.2% (NR)P>0.05
Sharma 200612Pioglitazone
15–30 mg daily
Metformin
1000–2000 mg daily
Gliclazide
30–60 mg daily added to both arms if needed
7.72% (1.1%)7.3% (0.8%)
P=0.34
8.03% (0.9%)7.56% (0.8%)
P=0.14
−0.05% (NR)0.43
Teramoto 200724Pioglitazone
15–30 mg daily
Glibenclamide
1.25–2.5 mg daily
8.01% (1.29%)7.21% (1.35%)
P<0.05
8.21% (1.29%)6.93% (0.74%)
P<0.05
0.63% (NR)<0.05
Umpierrez 200626Pioglitazone
30–45 mg daily
Glimepiride
2–8 mg daily
Add-on to metformin therapy
8.31% (0.77%)Change: − 1.23% (SE 0.073)

A1c 7.0% in 55% of group
8.4% (0.72%)Change: −1.30% (SE 0.077)

A1c 7.0% in 56% of group
0.07% (NR)0.4825
Yamanouchi 200552Pioglitazone
30–45 mg daily
Metformin
750 mg daily
Glimepiride
1.0–2.0 mg daily

Monotherapy
10.2% (0.8%)7.9% (1.0%)
P<0.005
Metformin:
9.9% (0.7%)

Glimepiride:
9.8% (0.7%)
Metformin:
7.8% (1.0%)
P<0.005

Glimepiride
7.7% (0.9%)
P<0.005
Metformin:
−0.2% (NR)

Glimepiride:
−0.2% (NR)
NSD among the 3 groups

Abbreviations: CI, confidence interval; NR, not recorded; NSD, no significant difference; SE, standard error.

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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