Efficacy and Safety of Pioglitazone and Metformin Combina... | NCT00727857

ID	Type	Description	Link
U1111-1114-0371	Registry Identifier	WHO

Status Module

Description Module

Label	Type	Intervention Names
Pioglitazone 15 mg /Metformin 850 mg BID	Experimental	Drug: Pioglitazone and metformin
Pioglitazone 15 mg BID	Active Comparator	Drug: Pioglitazone
Metformin 850 mg BID	Active Comparator	Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone and metformin	Drug	Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.	Pioglitazone 15 mg /Metformin 850 mg BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Glycosylated Hemoglobin	The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.	Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose	The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.	Baseline and Week 24
Change From Baseline in Fasting Insulin

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Has type 2 diabetes.
Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.
A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.
Body mass index less than or equal to 45 kg/m2.
Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Stable condition as determined by a physician.

Exclusion Criteria

Type 1 diabetes.
Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.
Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.
Has a triglyceride level greater than 500 mg per dL.
Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.
Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Antidiabetic medications other than study medication
- Chronically used oral or parenteral glucocorticoids
- Niacin greater than 200 mg per day, including niacin-containing products such as Advicor
- Chronically used steroid-joint injections

Name	Affiliation	Role
VP Clinical Science Strategy	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19827910	Background	Perez A, Zhao Z, Jacks R, Spanheimer R. Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. Curr Med Res Opin. 2009 Dec;25(12):2915-23. doi: 10.1185/03007990903350011.
21122063	Result	Perez A, Jacks R, Arora V, Spanheimer R. Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. J Clin Hypertens (Greenwich). 2010 Dec;12(12):973-82. doi: 10.1111/j.1751-7176.2010.00389.x. Epub 2010 Nov 8.

Label	URL
ACTOPLUS MET® Package Insert	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
FG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Glycosylated Hemoglobin

The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.

Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000188 OG001162 OG002193

Title

Denominators

Categories

Title	Measurements
	OG000-1.83± 0.122 OG001-0.96± 0.131 OG002-0.99± 0.120

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.	ANCOVA		<0.0001		Mean Difference (Final Values)	0.86				95	0.51	1.22			Mean Difference = Pioglitazone & metformin - pioglitazone	No	Superiority or Other

Secondary

Change From Baseline in Fasting Plasma Glucose

The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Insulin

The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

μIU/mL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Homeostasis Model Assessment - Insulin Resistance

The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

percent of insulin resistance

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Secondary

Median Percent Change From Baseline in High Sensitivity C-reactive Protein

Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100

Posted

Median

Full Range

percent

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Adiponectin

The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mcg/ml

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Total Cholesterol

The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Low-Density Lipoprotein Cholesterol

The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in High-Density Lipoprotein Cholesterol

The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Triglycerides

The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Mean Low Density Lipoprotein Particle Concentration

The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Mean Low Density Lipoprotein Particle Size

The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Deviation

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Large Low Density Lipoprotein (L3) Concentration

The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration

The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Medium-Small Low Density Lipoprotein Concentration

The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Small Low Density Lipoprotein Concentration

The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Very Small Low Density Lipoprotein Concentration

The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean High Density Lipoprotein Particle Concentration

The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Error

μmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean High Density Lipoprotein Particle Size

The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Error

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration

The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

μmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration

The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

μmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration

The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

μmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration

The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Very Low Density Lipoprotein Particle Size

The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.

Posted

Least Squares Mean

Standard Error

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration

The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration

The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration

The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline

Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline and Week 24

ID	Title	Description
OG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
OG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
OG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0010 affected190 at risk EG0021 affected209 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0011 affected190 at risk EG0020 affected209 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected201 at risk EG0010 affected190 at risk EG0020 affected209 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0010 affected190 at risk EG0021 affected209 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0010 affected190 at risk EG0021 affected209 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0010 affected190 at risk EG0021 affected209 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0010 affected190 at risk EG0021 affected209 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0011 affected190 at risk EG0020 affected209 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected201 at risk EG0010 affected190 at risk EG0020 affected209 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected201 at risk EG0011 affected190 at risk EG0020 affected209 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected201 at risk EG0015 affected190 at risk EG00232 affected209 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected201 at risk EG0013 affected190 at risk EG0027 affected209 at risk
Oedema Peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected201 at risk EG0018 affected190 at risk EG0023 affected209 at risk
Pharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected201 at risk EG0015 affected190 at risk EG0027 affected209 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 affected201 at risk EG0015 affected190 at risk EG0029 affected209 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected201 at risk EG0013 affected190 at risk EG0025 affected209 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected201 at risk EG0017 affected190 at risk EG0023 affected209 at risk
Glycosylated haemoglobin	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected201 at risk EG0017 affected190 at risk EG0027 affected209 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected201 at risk EG0018 affected190 at risk EG0026 affected209 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected201 at risk EG0015 affected190 at risk EG00210 affected209 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected201 at risk EG0013 affected190 at risk EG0024 affected209 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected201 at risk EG0012 affected190 at risk EG0022 affected209 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D003924	Diabetes Mellitus, Type 2
D003923	Diabetes Mellitus, Lipoatrophic
D050171	Dyslipidemias

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D052439	Lipid Metabolism Disorders

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines

ID	Title	Description
BG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
BG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
BG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pioglitazone 15 mg/Metformin 850 mg BID	Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks	2	201	84	201
EG001	Pioglitazone 15 mg BID	Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks	3	190	61	190
EG002	Metformin 850 mg BID	Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.	5	209	95	209