Evidence Table 5

Placebo-controlled trials of pioglitazone (new for Update #1)

Author, yearInclusion CriteriaExclusion CriteriaBaseline DemographicsBaseline CharacteristicsInterventionTotal Daily DoseSample SizeOutcome MeasureResults
Belfort, 2006the diagnosis of nonalcoholic steatohepatitis and impaired glucose tolerance or type 2 diabetesnormal results on the oral glucose tolerance test;abnormal findings on laboratory tests; levels of plasma aspartate aminotransferase andalanine aminotransferase were 2.5 times or morethe upper limit of the normal range; history of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits); fasting glucose level of 240 mg per deciliter (13.3 mmol per liter) or greater; type 1 diabetes, heart disease, hepatic disease (other than nonalcoholic steatohepatitis), or renal disease; receivingmetformin, thiazolidinediones, or insulin.Mean age:51; Male: 44.68%; Female: 55.32%; White: %; Black:A1c: ; Weight:92.1; BMI: ; Duration of diabetes:Placebo21at
BMI change at 26 weekschange -0.2, p=0.62 vs baseline
Weight at 26 weekschange -0.5, p=0.53 vs baseline
Pioglitazone monotherapy30 mg26BMI at 26 weekschange 1.1,
HbA1c at 26 weekschange -0.7, p<0.001 vs baseline
Weight at 26 weekschange 2.5 (weight gain), p<0.001 vs baseline
Placebo47HbA1c at 26 weekschange -0.1, p=0.73 vs baseline
Healthy diabetic subjects. Not taking any medication other than sulfonylureas known to affect glucose or lipid metabolism. Body weight stable for >or= 3 months of the study and no subject participated in a heavy exercise program prior to the study. Subjects were asked to consume a weight maintaining diet containing 50% cardohydrate, 30% fat and 20% protein for 3 days prior to the study.NRMean age:53; Male: .%; Female: .%; White: %; Black:A1c:8.2; Weight: ; BMI:29.4; Duration of diabetes:.BMI at 4 monthsBMI at 4 mos(Kg/m2) : 28.4 (SE 1.2), p<0.01 pre vs. post
HbA1c at 4 months% HbA1C at 4 mos: 6.6 (SE 0.4), p<0.01 pre vs. post
Pioglitazone+SU45mg10BMI at 4 monthsBMI at 4 mos (Kg/m2): 30.0 (SE 1.4), change +1.1 p< 0.01 pre vs. post
HbA1c at 4 months% HbA1c at 4 mos: 7.3 (SE 0.6), change -2.0 p< 0.01 pre vs. post, p<0.001 vs. placebo
Placebo+SUBMI atBMI at 4 mos (kg/m2):29.8 (SE 1.4), , change -0.1 p-value=NS
HbA1c at 4 months% HbA1c at 4 mos: 9.2 (SE 0.5), change +0.9
Placebo12BMI at 4 monthsBMI at 4 mos (Kg/m2): 30.0 (SE 1.2), change +0.2, P-value>0.05
HbA1c at 4 months% HbA1c at 4 mos: 8.7 (SE 0.5), change +0.6
atThis group was not studied.
Nishio, 2006Acute coronary syndrome and type 2 diabetes who had received coronary stenting were eligible for the study if their homeostasis model assessment of insulin resistance (HOMA-IR) was >2.0Spastic angina pectoris, congestive heart failure, hepatic dysfunction, chronic renal disease, recent stroke, impaired glucose tolerance, insulin-dependent diabetes, familial hypercholesterolemia, thyroid dysfunction, adrenal dysfunction, or an intolerance of aspirin, ticlopidine, heparin,Mean age:66.9; Male: 72.2%; Female: 27.8%; White: %; Black:A1c:7.3; Weight: ; BMI:24.6; Duration of diabetes:Pioglitazone monotherapy30 mg26BMI at 26 weekschange +0.1between group p=0.818
HbA1c at 26 weekschange -1.7, between group p=0.263
No treatment28BMI at 26 weekschange -0.1
No treatment54HbA1c at 26 weekschange -0.4
Sourij, 2006stable CAD and recently detected type 2 diabetesdiabetes by history or fasting blood glucose >6.1 mmol/l, acute coronary syndrome or cerebrovascular event within the previous 8 weeks, heart failure according to NYHA IIIMean age:60.25; Male: 92.86%; Female: 7.14%; White: %; Black:A1c:6.1; Weight: ; BMI:28.2; Duration of diabetes:Pioglitazone monotherapy30 mg21HbA1c at 12 weeks6.1 (0.6), change 0%
Placebo42HbA1c at 12 weeks5.9 (0.4), change -0.2, between group p>0.05
Tseng, 2005Type 2 diabetics in TaiwanNRMean age:56.19; Male: 35.42%; Female: 64.58%; White: %; Black:A1c: ; Weight:61.97; BMI: ; Duration of diabetes:Pioglitazone+various SU30 mg23Weight at 12 weekschange 1.2
Placebo+existin g SU25HbA1c at 12 weekspercent change at endpoint 2.6
Weight at 12 weeksno change
Pioglitazone+va rious SU30 mg48HbA1c at 12 weekspercent change at endpoint -8.7

From: Evidence Tables

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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