|
Diabetes Care, Vol 23, Issue 11 1605-1611, Copyright © 2000 by American Diabetes Association
Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. The Pioglitazone 001 Study Group
S Aronoff, S Rosenblatt, S Braithwaite, JW Egan, AL Mathisen and RL Schneider
Research Institute of Dallas, Texas, USA.
OBJECTIVE: To evaluate the efficacy and safety of four doses of
pioglitazone monotherapy in the treatment of patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS: There were 408 patients randomized in this
multicenter double-blind placebo-controlled clinical trial. Patients who
had HbA1c > or = 7.0%, fasting plasma glucose (FPG) > or = 140 mg/dl,
and C-peptide > 1 ng/ml were randomized to receive placebo or 7.5, 15,
30, or 45 mg pioglitazone administered once a day for 26 weeks. RESULTS:
Patients treated with 15, 30, or 45 mg pioglitazone had significant mean
decreases in HbA1c (range -1.00 to -1.60% difference from placebo) and FPG
(-39.1 to -65.3 mg/dl difference from placebo). The decreases in FPG were
observed as early as the second week of therapy; maximal decreases occurred
after 10-14 weeks and were maintained until the end of therapy (week 26).
In the 15-, 30-, or 45-mg pioglitazone groups, there were significant mean
percent decreases in triglycerides, significant mean percent increases in
HDL cholesterol, and only small percent changes in total cholesterol and
LDL. The subset of patients naive to therapy had greater improvements in
HbA1c and FPG (difference from placebo of -2.55% and -79.9 mg/dl for the
45-mg group) compared with previously treated patients. The overall adverse
event profile of pioglitazone was similar to that of placebo. There was no
evidence of drug-induced hepatotoxicity or drug-induced elevations of
alanine aminotransferase levels in this study CONCLUSIONS: Pioglitazone
monotherapy significantly improves HbA1c and FPG while producing beneficial
effects on serum lipids in patients with type 2 diabetes with no evidence
of drug-induced hepatotoxicity.

CiteULike Del.icio.us Digg Reddit Technorati What's this?
This article has been cited by other articles:

|
 |

|
 |
 
E. Selvin, S. Bolen, H.-C. Yeh, C. Wiley, L. M. Wilson, S. S. Marinopoulos, L. Feldman, J. Vassy, R. Wilson, E. B. Bass, et al.
Cardiovascular Outcomes in Trials of Oral Diabetes Medications: A Systematic Review
Arch Intern Med,
October 27, 2008;
168(19):
2070 - 2080.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
X. Ruan, F. Zheng, and Y. Guan
PPARs and the kidney in metabolic syndrome
Am J Physiol Renal Physiol,
May 1, 2008;
294(5):
F1032 - F1047.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. F. Kruger
Exploring the Pharmacotherapeutic Options for Treating Type 2 Diabetes
The Diabetes Educator,
May 1, 2008;
34(Supplement_3):
60S - 65S.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. K. McGuire and S. E. Inzucchi
New Drugs for the Treatment of Diabetes Mellitus: Part I: Thiazolidinediones and Their Evolving Cardiovascular Implications
Circulation,
January 22, 2008;
117(3):
440 - 449.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
X. Hou, R. Liu, S. Ross, E. J. Smart, H. Zhu, and W. Gong
Crystallographic Studies of Human MitoNEET
J. Biol. Chem.,
November 16, 2007;
282(46):
33242 - 33246.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Hollander
Anti-Diabetes and Anti-Obesity Medications: Effects on Weight in People With Diabetes
Diabetes Spectr,
July 1, 2007;
20(3):
159 - 165.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. Menzaghi, V. Trischitta, and A. Doria
Genetic Influences of Adiponectin on Insulin Resistance, Type 2 Diabetes, and Cardiovascular Disease
Diabetes,
May 1, 2007;
56(5):
1198 - 1209.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. H Barnett
Summarising the use of thiazolidinediones with insulin
The British Journal of Diabetes & Vascular Disease,
March 1, 2007;
7(2):
75 - 80.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
M. J. Serlie, G. Allick, J. E. Groener, M. T. Ackermans, R. Heijligenberg, B. C. Voermans, J. M. Aerts, A. J. Meijer, and H. P. Sauerwein
Chronic Treatment with Pioglitazone Does Not Protect Obese Patients with Diabetes Mellitus Type II from Free Fatty Acid-Induced Insulin Resistance
J. Clin. Endocrinol. Metab.,
January 1, 2007;
92(1):
166 - 171.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
W. S. Shim, S. K. Kim, H. J. Kim, E. S. Kang, C. W. Ahn, S. K. Lim, H. C. Lee, and B. S. Cha
Decrement of postprandial insulin secretion determines the progressive nature of type-2 diabetes.
Eur. J. Endocrinol.,
October 1, 2006;
155(4):
615 - 622.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. F. Pilch and N. Bergenhem
Pharmacological Targeting of Adipocytes/Fat Metabolism for Treatment of Obesity and Diabetes
Mol. Pharmacol.,
September 1, 2006;
70(3):
779 - 785.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. N. Hodis, W. J. Mack, L. Zheng, Y. Li, M. Torres, D. Sevilla, Y. Stewart, B. Hollen, K. Garcia, P. Alaupovic, et al.
Effect of Peroxisome Proliferator-Activated Receptor {gamma} Agonist Treatment on Subclinical Atherosclerosis in Patients With Insulin-Requiring Type 2 Diabetes
Diabetes Care,
July 1, 2006;
29(7):
1545 - 1553.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. M. Kendall, C. J. Rubin, P. Mohideen, J.-M. Ledeine, R. Belder, J. Gross, P. Norwood, M. O'Mahony, K. Sall, G. Sloan, et al.
Improvement of Glycemic Control, Triglycerides, and HDL Cholesterol Levels With Muraglitazar, a Dual ({alpha}/{gamma}) Peroxisome Proliferator-Activated Receptor Activator, in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: A double-blind, randomized, pioglitazone-comparative study
Diabetes Care,
May 1, 2006;
29(5):
1016 - 1023.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. T. Beckley
Diabetes Drug Reportedly Cuts Death, Heart Attack, Stroke Risk
DOC News,
December 1, 2005;
2(12):
1 - 11.
[Full Text]
|
 |
|

|
 |

|
 |
 
J. K. Wolford, K. A. Yeatts, S. K. Dhanjal, M. H. Black, A. H. Xiang, T. A. Buchanan, and R. M. Watanabe
Sequence Variation in PPARG May Underlie Differential Response to Troglitazone
Diabetes,
November 1, 2005;
54(11):
3319 - 3325.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. Kahn, J. Buse, E. Ferrannini, and M. Stern
The Metabolic Syndrome: Time for a Critical Appraisal: Joint statement from the American Diabetes Association and the European Association for the Study of Diabetes
Diabetes Care,
September 1, 2005;
28(9):
2289 - 2304.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. W Campbell
Pioglitazone -- an oral antidiabetic agent and metabolic syndrome modulator. Can theory translate into practice?
The British Journal of Diabetes & Vascular Disease,
July 1, 2005;
5(4):
209 - 216.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
R. B. Goldberg, D. M. Kendall, M. A. Deeg, J. B. Buse, A. J. Zagar, J. A. Pinaire, M. H. Tan, M. A. Khan, A. T. Perez, S. J. Jacober, et al.
A Comparison of Lipid and Glycemic Effects of Pioglitazone and Rosiglitazone in Patients With Type 2 Diabetes and Dyslipidemia
Diabetes Care,
July 1, 2005;
28(7):
1547 - 1554.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Reifel-Miller, K. Otto, E. Hawkins, R. Barr, W. R. Bensch, C. Bull, S. Dana, K. Klausing, J.-A. Martin, R. Rafaeloff-Phail, et al.
A Peroxisome Proliferator-Activated Receptor {alpha}/{gamma} Dual Agonist with a Unique in Vitro Profile and Potent Glucose and Lipid Effects in Rodent Models of Type 2 Diabetes and Dyslipidemia
Mol. Endocrinol.,
June 1, 2005;
19(6):
1593 - 1605.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. Kimmel and S. E. Inzucchi
Oral Agents for Type 2 Diabetes: An Update
Clin. Diabetes,
April 1, 2005;
23(2):
64 - 76.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. H. Xiang, R. K. Peters, S. L. Kjos, C. Ochoa, A. Marroquin, J. Goico, S. Tan, C. Wang, S. P. Azen, C.-r. Liu, et al.
Effect of Thiazolidinedione Treatment on Progression of Subclinical Atherosclerosis in Premenopausal Women at High Risk for Type 2 Diabetes
J. Clin. Endocrinol. Metab.,
April 1, 2005;
90(4):
1986 - 1991.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. A. Masoudi, S. E. Inzucchi, Y. Wang, E. P. Havranek, J. M. Foody, and H. M. Krumholz
Thiazolidinediones, Metformin, and Outcomes in Older Patients With Diabetes and Heart Failure: An Observational Study
Circulation,
February 8, 2005;
111(5):
583 - 590.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Y.Y. Cheng and I. G. Fantus
Oral antihyperglycemic therapy for type 2 diabetes mellitus
Can. Med. Assoc. J.,
January 18, 2005;
172(2):
213 - 226.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Bongartz, B. Coras, T. Vogt, J. Scholmerich, and U. Muller-Ladner
Treatment of active psoriatic arthritis with the PPAR{gamma} ligand pioglitazone: an open-label pilot study
Rheumatology,
January 1, 2005;
44(1):
126 - 129.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. Schernthaner, D. R. Matthews, B. Charbonnel, M. Hanefeld, P. Brunetti, and on Behalf of the Quarter Study Group
Efficacy and Safety of Pioglitazone Versus Metformin in Patients with Type 2 Diabetes Mellitus: A Double-Blind, Randomized Trial
J. Clin. Endocrinol. Metab.,
December 1, 2004;
89(12):
6068 - 6076.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y. Guan
Peroxisome Proliferator-Activated Receptor Family and Its Relationship to Renal Complications of the Metabolic Syndrome
J. Am. Soc. Nephrol.,
November 1, 2004;
15(11):
2801 - 2815.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. Chiquette, G. Ramirez, and R. DeFronzo
A Meta-analysis Comparing the Effect of Thiazolidinediones on Cardiovascular Risk Factors
Arch Intern Med,
October 25, 2004;
164(19):
2097 - 2104.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. Yki-Jarvinen
Thiazolidinediones
N. Engl. J. Med.,
September 9, 2004;
351(11):
1106 - 1118.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. Boden and M. Laakso
Lipids and Glucose in Type 2 Diabetes: What is the cause and effect?
Diabetes Care,
September 1, 2004;
27(9):
2253 - 2259.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Zander, A. Christiansen, S. Madsbad, and J. Juul Holst
Additive Effects of Glucagon-Like Peptide 1 and Pioglitazone in Patients With Type 2 Diabetes
Diabetes Care,
August 1, 2004;
27(8):
1910 - 1914.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. Charbonnel, J. Dormandy, E. Erdmann, M. Massi-Benedetti, and A. Skene
The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive): Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5,238 patients
Diabetes Care,
July 1, 2004;
27(7):
1647 - 1653.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. H. Tan, D. Johns, and N. B. Glazer
Pioglitazone Reduces Atherogenic Index of Plasma in Patients with Type 2 Diabetes
Clin. Chem.,
July 1, 2004;
50(7):
1184 - 1188.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C M. B Edwards
GLP-1: target for a new class of antidiabetic agents?
J R Soc Med,
June 1, 2004;
97(6):
270 - 274.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. F. Saad, S. Greco, K. Osei, A. J. Lewin, C. Edwards, M. Nunez, and R. R. Reinhardt
Ragaglitazar Improves Glycemic Control and Lipid Profile in Type 2 Diabetic Subjects: A 12-week, double-blind, placebo-controlled dose-ranging study with an open pioglitazone arm
Diabetes Care,
June 1, 2004;
27(6):
1324 - 1329.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. M. Krauss
Lipids and Lipoproteins in Patients With Type 2 Diabetes
Diabetes Care,
June 1, 2004;
27(6):
1496 - 1504.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Gehrmann, M. Brunner, K. Pfister, A. Reichle, E. Kremmer, and G. Multhoff
Differential Up-Regulation of Cytosolic and Membrane-Bound Heat Shock Protein 70 in Tumor Cells by Anti-Inflammatory Drugs
Clin. Cancer Res.,
May 15, 2004;
10(10):
3354 - 3364.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Q. Guo, S. P. Sahoo, P.-R. Wang, D. P. Milot, M. C. Ippolito, M. S. Wu, J. Baffic, C. Biswas, M. Hernandez, M.-H. Lam, et al.
A Novel Peroxisome Proliferator-Activated Receptor {alpha}/{gamma} Dual Agonist Demonstrates Favorable Effects on Lipid Homeostasis
Endocrinology,
April 1, 2004;
145(4):
1640 - 1648.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. Ludvik, B. Neuffer, and G. Pacini
Efficacy of Ipomoea batatas (Caiapo) on Diabetes Control in Type 2 Diabetic Subjects Treated With Diet
Diabetes Care,
February 1, 2004;
27(2):
436 - 440.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. M. Lawrence, J. Reid, G. J. Taylor, C. Stirling, and J. P.D. Reckless
Favorable Effects of Pioglitazone and Metformin Compared With Gliclazide on Lipoprotein Subfractions in Overweight Patients With Early Type 2 Diabetes
Diabetes Care,
January 1, 2004;
27(1):
41 - 46.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Hanefeld, P. Brunetti, G. H. Schernthaner, D. R. Matthews, and B. H. Charbonnel
One-Year Glycemic Control With a Sulfonylurea Plus Pioglitazone Versus a Sulfonylurea Plus Metformin in Patients With Type 2 Diabetes
Diabetes Care,
January 1, 2004;
27(1):
141 - 147.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. R. Diani, G. Sawada, B. Wyse, F. T. Murray, and M. Khan
Pioglitazone preserves pancreatic islet structure and insulin secretory function in three murine models of type 2 diabetes
Am J Physiol Endocrinol Metab,
January 1, 2004;
286(1):
E116 - E122.
[Abstract]
[Full Text]
|
 |
|

|
 |

|
 |
 
M. B. Davidson
Is Treatment of Insulin Resistance Beneficial Independent of Glycemia?
Diabetes Care,
November 1, 2003;
26(11):
3184 - 3186.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. K. Skrumsager, K. K. Nielsen, M. Muller, G. Pabst, P. G. Drake, and B. Edsberg
Ragaglitazar: The Pharmacokinetics, Pharmacodynamics, and Tolerability of a Novel Dual PPAR{alpha} and {gamma} Agonist in Healthy Subjects and Patients with Type 2 Diabetes
J. Clin. Pharmacol.,
November 1, 2003;
43(11):
1244 - 1256.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
V. De Leo, A. la Marca, and F. Petraglia
Insulin-Lowering Agents in the Management of Polycystic Ovary Syndrome
Endocr. Rev.,
October 1, 2003;
24(5):
633 - 667.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. P.H. van Wijk, E. J.P. de Koning, E. P. Martens, and T. J. Rabelink
Thiazolidinediones and Blood Lipids in Type 2 Diabetes
Arterioscler. Thromb. Vasc. Biol.,
October 1, 2003;
23(10):
1744 - 1749.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Winkler, T. Konrad, S. Fullert, I. Friedrich, R. Destani, M. W. Baumstark, K. Krebs, H. Wieland, and W. Marz
Pioglitazone Reduces Atherogenic Dense LDL Particles in Nondiabetic Patients With Arterial Hypertension: A double-blind, placebo-controlled study
Diabetes Care,
September 1, 2003;
26(9):
2588 - 2594.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y. Miyazaki, H. He, L. J. Mandarino, and R. A. DeFronzo
Rosiglitazone Improves Downstream Insulin Receptor Signaling in Type 2 Diabetic Patients
Diabetes,
August 1, 2003;
52(8):
1943 - 1950.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
W. N. Kernan, S. E. Inzucchi, C. M. Viscoli, L. M. Brass, D. M. Bravata, G. I. Shulman, J. C. McVeety, and R. I. Horwitz
Pioglitazone Improves Insulin Sensitivity Among Nondiabetic Patients With a Recent Transient Ischemic Attack or Ischemic Stroke
Stroke,
June 1, 2003;
34(6):
1431 - 1436.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. K. S. Leow, C. L. Addy, and C. S. Mantzoros
Human Immunodeficiency Virus/Highly Active Antiretroviral Therapy-Associated Metabolic Syndrome: Clinical Presentation, Pathophysiology, and Therapeutic Strategies
J. Clin. Endocrinol. Metab.,
May 1, 2003;
88(5):
1961 - 1976.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. Pavo, G. Jermendy, T. T. Varkonyi, Z. Kerenyi, A. Gyimesi, S. Shoustov, M. Shestakova, M. Herz, D. Johns, B. J. Schluchter, et al.
Effect of Pioglitazone Compared with Metformin on Glycemic Control and Indicators of Insulin Sensitivity in Recently Diagnosed Patients with Type 2 Diabetes
J. Clin. Endocrinol. Metab.,
April 1, 2003;
88(4):
1637 - 1645.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. L. Brand, J. Sturis, C. F. Gotfredsen, J. Fleckner, C. Fledelius, B. F. Hansen, B. Andersen, J.-M. Ye, P. Sauerberg, and K. Wassermann
Dual PPARalpha /gamma activation provides enhanced improvement of insulin sensitivity and glycemic control in ZDF rats
Am J Physiol Endocrinol Metab,
April 1, 2003;
284(4):
E841 - E854.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Bluher, G. Lubben, and R. Paschke
Analysis of the Relationship Between the Pro12Ala Variant in the PPAR-{gamma}2 Gene and the Response Rate to Therapy With Pioglitazone in Patients With Type 2 Diabetes
Diabetes Care,
March 1, 2003;
26(3):
825 - 831.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. K. Campbell and J. White
Counseling Patients With Type 2 Diabetes and Insulin Resistance in the Outpatient Setting
The Diabetes Educator,
November 1, 2002;
28(6):
938 - 957.
[PDF]
|
 |
|

|
 |

|
 |
 
J. A. Beckman, M. A. Creager, and P. Libby
Diabetes and Atherosclerosis: Epidemiology, Pathophysiology, and Management
JAMA,
May 15, 2002;
287(19):
2570 - 2581.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Winkler, I. Friedrich, M. W Baumstark, H. Wieland, and W. Marz
Pioglitazone reduces atherogenic dense low density lipoprotein (LDL) particles in patients with type 2 diabetes mellitus
The British Journal of Diabetes & Vascular Disease,
March 1, 2002;
2(2):
143 - 148.
[Abstract]
[PDF]
|
 |
|
|