Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 134 investigative sites in the United States (including Puerto Rico), Argentina, Chile, Guatemala, Mexico and Peru from 13 June 2007 to 29 August 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had not received treatment with antidiabetic medication 12 weeks prior to Screening were enrolled in one of three, twice-daily (BID) treatment groups.

Reporting Groups

	Description
Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Participant Flow:   Overall Study

	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg BID	Metformin 850 mg BID
STARTED	201	189	210
COMPLETED	157	125	142
NOT COMPLETED	44	64	68

Reporting Groups

	Description
Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Baseline Measures

	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg BID	Metformin 850 mg BID	Total
Number of Participants   [units: participants]	201	189	210	600
Age   [units: years] Mean ± Standard Deviation	54.7  ± 12.23	54.0  ± 12.08	53.7  ± 12.00	54.1  ± 12.09
Gender   [units: participants]
Female	111	123	112	346
Male	90	66	98	254
Race/Ethnicity, Customized   [units: participants]
American Indian or Alaska Native	2	6	6	14
Asian	3	5	5	13
Black or African American	12	13	14	39
Native Hawaiian or Other Pacific Islander	0	0	0	0
White	123	109	124	356
Multiracial	61	56	61	178
Body Mass Index   [units: kg/m²] Mean ± Standard Deviation	30.84  ± 5.74	31.18  ± 5.50	30.83  ± 5.66	30.94  ± 5.63

1.  Primary:

Percent Change From Baseline in Glycosylated Hemoglobin   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:

Change From Baseline in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:

Change From Baseline in Fasting Insulin   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:

Change From Baseline in Homeostasis Model Assessment - Insulin Resistance   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:

Median Percent Change From Baseline in High Sensitivity C-reactive Protein   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:

Change From Baseline in Adiponectin   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:

Change From Baseline in Total Cholesterol   [ Time Frame: Baseline and Week 24 ]

8.  Secondary:

Change From Baseline in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:

Change From Baseline in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:

Change From Baseline in Triglycerides   [ Time Frame: Baseline and Week 24 ]

11.  Secondary:

Change From Baseline in Mean Low Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

12.  Secondary:

Change From Baseline in Mean Low Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

13.  Secondary:

Change From Baseline in Large Low Density Lipoprotein (L3) Concentration   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:

Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:

Change From Baseline in Medium-Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

16.  Secondary:

Change From Baseline in Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

17.  Secondary:

Change From Baseline in Very Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

18.  Secondary:

Change From Baseline in Mean High Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:

Change From Baseline in Mean High Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

20.  Secondary:

Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:

Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:

Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration   [ Time Frame: Baseline and Week 24 ]

23.  Secondary:

Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

24.  Secondary:

Change From Baseline in Mean Very Low Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

25.  Secondary:

Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

26.  Secondary:

Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration   [ Time Frame: Baseline and Week 24 ]

27.  Secondary:

Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration   [ Time Frame: Baseline and Week 24 ]