Diabetes Mellitus
Conditions
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
Brief summary
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Detailed description
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism. Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents. This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy. Study participation is anticipated to be approximately 6.5 months.
Interventions
Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
DRUGPioglitazone
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
DRUGMetformin
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Glycosylated Hemoglobin | Baseline and Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Insulin | Baseline and Week 24 | The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline. |
| Change From Baseline in Homeostasis Model Assessment - Insulin Resistance | Baseline and Week 24 | 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). |
| Median Percent Change From Baseline in High Sensitivity C-reactive Protein | Baseline and Week 24 | 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 |
| Change From Baseline in Adiponectin | Baseline and Week 24 | The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline. |
| Change From Baseline in Total Cholesterol | Baseline and Week 24 | The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol | Baseline and Week 24 | The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline. |
| Change From Baseline in High-Density Lipoprotein Cholesterol | Baseline and Week 24 | The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline. |
| Change From Baseline in Triglycerides | Baseline and Week 24 | The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline. |
| Change From Baseline in Mean Low Density Lipoprotein Particle Concentration | Baseline and Week 24 | The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline. |
| Change From Baseline in Mean Low Density Lipoprotein Particle Size | Baseline and Week 24 | The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline. |
| Change From Baseline in Large Low Density Lipoprotein (L3) Concentration | Baseline and Week 24 | The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline. |
| Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration | Baseline and Week 24 | The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline |
| Change From Baseline in Fasting Plasma Glucose | Baseline and Week 24 | The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline. |
| Change From Baseline in Small Low Density Lipoprotein Concentration | Baseline and Week 24 | The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline |
| Change From Baseline in Very Small Low Density Lipoprotein Concentration | Baseline and Week 24 | The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline |
| Change From Baseline in Mean High Density Lipoprotein Particle Concentration | Baseline and Week 24 | The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline. |
| Change From Baseline in Mean High Density Lipoprotein Particle Size | Baseline and Week 24 | The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline. |
| Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration | Baseline and Week 24 | The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline |
| Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration | Baseline and Week 24 | The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline |
| Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration | Baseline and Week 24 | The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline |
| Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration | Baseline and Week 24 | The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline. |
| Change From Baseline in Mean Very Low Density Lipoprotein Particle Size | Baseline and Week 24 | The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline. |
| Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration | Baseline and Week 24 | 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 |
| Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration | Baseline and Week 24 | 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 |
| Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration | Baseline and Week 24 | The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline |
| Change From Baseline in Medium-Small Low Density Lipoprotein Concentration | Baseline and Week 24 | The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline |
Countries
Chile, Mexico, Puerto Rico, United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks | 201 |
| Pioglitazone 15 mg BID Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks | 189 |
| Metformin 850 mg BID Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. | 210 |
| Total | 600 |
Baseline characteristics
| Characteristic | Total | Pioglitazone 15 mg/Metformin 850 mg BID | Pioglitazone 15 mg BID | Metformin 850 mg BID |
|---|---|---|---|---|
| Age Continuous | 54.1 years STANDARD_DEVIATION 12.09 | 54.7 years STANDARD_DEVIATION 12.23 | 54.0 years STANDARD_DEVIATION 12.08 | 53.7 years STANDARD_DEVIATION 12 |
| Body Mass Index | 30.94 kg/m² STANDARD_DEVIATION 5.63 | 30.84 kg/m² STANDARD_DEVIATION 5.74 | 31.18 kg/m² STANDARD_DEVIATION 5.5 | 30.83 kg/m² STANDARD_DEVIATION 5.66 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 14 participants | 2 participants | 6 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 13 participants | 3 participants | 5 participants | 5 participants |
| Race/Ethnicity, Customized Black or African American | 39 participants | 12 participants | 13 participants | 14 participants |
| Race/Ethnicity, Customized Multiracial | 178 participants | 61 participants | 56 participants | 61 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 356 participants | 123 participants | 109 participants | 124 participants |
| Sex: Female, Male Female | 346 Participants | 111 Participants | 123 Participants | 112 Participants |
| Sex: Female, Male Male | 254 Participants | 90 Participants | 66 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 84 / 201 | 61 / 190 | 95 / 209 |
| serious Total, serious adverse events | 2 / 201 | 3 / 190 | 5 / 209 |
Outcome results
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Percent Change From Baseline in Glycosylated Hemoglobin | -1.83 percentage of Glycosylated Hemoglobin | Standard Error 0.122 |
| Pioglitazone 15 mg BID | Percent Change From Baseline in Glycosylated Hemoglobin | -0.96 percentage of Glycosylated Hemoglobin | Standard Error 0.131 |
| Metformin 850 mg BID | Percent Change From Baseline in Glycosylated Hemoglobin | -0.99 percentage of Glycosylated Hemoglobin | Standard Error 0.12 |
Comparison: 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.p-value: <0.000195% CI: [0.51, 1.22]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [0.5, 1.18]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.891995% CI: [-0.37, 0.33]ANCOVA
Secondary
Change From Baseline in Adiponectin
The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Adiponectin | 7.8 mcg/ml | Standard Error 0.55 |
| Pioglitazone 15 mg BID | Change From Baseline in Adiponectin | 9.2 mcg/ml | Standard Error 0.61 |
| Metformin 850 mg BID | Change From Baseline in Adiponectin | -0.3 mcg/ml | Standard Error 0.55 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.080695% CI: [-0.2, 3.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-9.6, -6.5]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-11.1, -7.9]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Fasting Insulin | -3.91 μIU/mL | Standard Error 0.736 |
| Pioglitazone 15 mg BID | Change From Baseline in Fasting Insulin | -3.18 μIU/mL | Standard Error 0.812 |
| Metformin 850 mg BID | Change From Baseline in Fasting Insulin | -0.98 μIU/mL | Standard Error 0.722 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.507495% CI: [-1.43, 2.88]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.004795% CI: [0.9, 4.95]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.043595% CI: [0.06, 4.33]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Fasting Plasma Glucose | -39.9 mg/dL | Standard Error 3.48 |
| Pioglitazone 15 mg BID | Change From Baseline in Fasting Plasma Glucose | -22.2 mg/dL | Standard Error 3.67 |
| Metformin 850 mg BID | Change From Baseline in Fasting Plasma Glucose | -24.8 mg/dL | Standard Error 3.42 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000595% CI: [7.8, 27.7]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.002195% CI: [5.5, 24.7]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.598195% CI: [-12.5, 7.2]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in High-Density Lipoprotein Cholesterol | 14.20 mg/dL | Standard Error 1.44 |
| Pioglitazone 15 mg BID | Change From Baseline in High-Density Lipoprotein Cholesterol | 9.88 mg/dL | Standard Error 1.552 |
| Metformin 850 mg BID | Change From Baseline in High-Density Lipoprotein Cholesterol | 6.09 mg/dL | Standard Error 1.426 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.042395% CI: [-8.48, -0.15]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-12.08, -4.12]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.72895% CI: [-7.93, 0.35]ANCOVA
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).
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Homeostasis Model Assessment - Insulin Resistance | -2.704 percent of insulin resistance | Standard Error 0.4274 |
| Pioglitazone 15 mg BID | Change From Baseline in Homeostasis Model Assessment - Insulin Resistance | -2.075 percent of insulin resistance | Standard Error 0.4586 |
| Metformin 850 mg BID | Change From Baseline in Homeostasis Model Assessment - Insulin Resistance | -1.085 percent of insulin resistance | Standard Error 0.4123 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.315895% CI: [-0.602, 1.861]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.006795% CI: [0.452, 2.785]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.109495% CI: [-0.223, 2.201]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration | -16.3 nmol/L | Standard Error 3.39 |
| Pioglitazone 15 mg BID | Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration | -11.0 nmol/L | Standard Error 3.66 |
| Metformin 850 mg BID | Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration | -17.3 nmol/L | Standard Error 3.37 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.289495% CI: [-4.5, 15.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.846395% CI: [-10.3, 8.5]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.212495% CI: [-16, 3.6]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration | 1.34 μmol/L | Standard Error 0.285 |
| Pioglitazone 15 mg BID | Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration | 1.62 μmol/L | Standard Error 0.308 |
| Metformin 850 mg BID | Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration | -0.09 μmol/L | Standard Error 0.283 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.504495% CI: [-0.54, 1.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000495% CI: [-2.22, -0.64]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-2.53, -0.89]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration | -1.71 nmol/L | Standard Error 0.351 |
| Pioglitazone 15 mg BID | Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration | -1.97 nmol/L | Standard Error 0.379 |
| Metformin 850 mg BID | Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration | -1.96 nmol/L | Standard Error 0.349 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.60995% CI: [-1.28, 0.75]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.616995% CI: [-1.22, 0.72]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.97495% CI: [-0.99, 1.03]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration | 0.70 μmol/L | Standard Error 1.8 |
| Pioglitazone 15 mg BID | Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration | 1.02 μmol/L | Standard Error 0.194 |
| Metformin 850 mg BID | Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration | 0.52 μmol/L | Standard Error 0.179 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.238495% CI: [-0.21, 0.83]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.461795% CI: [-0.69, 0.31]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.059395% CI: [-1.02, 0.02]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Large Low Density Lipoprotein (L3) Concentration | 96.0 nmol/L | Standard Error 12.53 |
| Pioglitazone 15 mg BID | Change From Baseline in Large Low Density Lipoprotein (L3) Concentration | 115.7 nmol/L | Standard Error 13.52 |
| Metformin 850 mg BID | Change From Baseline in Large Low Density Lipoprotein (L3) Concentration | 18.4 nmol/L | Standard Error 12.46 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.284995% CI: [-16.5, 55.9]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-112.4, -42.8]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-133.4, -61.2]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Low-Density Lipoprotein Cholesterol | 1.19 mg/dL | Standard Error 2.015 |
| Pioglitazone 15 mg BID | Change From Baseline in Low-Density Lipoprotein Cholesterol | 6.08 mg/dL | Standard Error 2.175 |
| Metformin 850 mg BID | Change From Baseline in Low-Density Lipoprotein Cholesterol | -1.37 mg/dL | Standard Error 1.998 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.099395% CI: [-0.93, 10.72]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.36795% CI: [-8.14, 3.01]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.011995% CI: [-13.26, -1.66]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Concentration | 0.28 μmol/L | Standard Error 0.271 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Concentration | -0.80 μmol/L | Standard Error 0.293 |
| Metformin 850 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Concentration | 0.62 μmol/L | Standard Error 0.269 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.007295% CI: [-1.86, -0.29]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.368295% CI: [-0.41, 1.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000495% CI: [0.64, 2.2]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Size | 0.15 nm | Standard Error 0.021 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Size | 0.19 nm | Standard Error 0.022 |
| Metformin 850 mg BID | Change From Baseline in Mean High Density Lipoprotein Particle Size | 0.11 nm | Standard Error 0.021 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.198695% CI: [-0.02, 0.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.148795% CI: [-0.1, 0.02]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.007695% CI: [-0.14, -0.02]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Concentration | -240.6 nmol/L | Standard Error 23.5 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Concentration | -217.2 nmol/L | Standard Error 25.4 |
| Metformin 850 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Concentration | -176.4 nmol/L | Standard Error 23.36 |
Comparison: One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.499995% CI: [-44.6, 91.4]ANCOVA
Comparison: One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.053195% CI: [-0.9, 129.3]ANCOVA
Comparison: One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.236995% CI: [-26.9, 108.7]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Size | 0.55 nm | Standard Deviation 0.049 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Size | 0.6 nm | Standard Deviation 0.053 |
| Metformin 850 mg BID | Change From Baseline in Mean Low Density Lipoprotein Particle Size | 0.2 nm | Standard Deviation 0.049 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.502395% CI: [-0.09, 0.19]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-0.48, -0.21]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-0.53, -0.25]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration | -2.78 nmol/L | Standard Error 2.204 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration | 0.98 nmol/L | Standard Error 2.381 |
| Metformin 850 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration | -11.30 nmol/L | Standard Error 2.191 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.246695% CI: [-2.61, 10.14]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.006395% CI: [-14.63, -2.42]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000295% CI: [-18.65, -5.93]ANCOVA
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.
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Size | -2.64 nm | Standard Error 0.616 |
| Pioglitazone 15 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Size | -3.79 nm | Standard Error 0.666 |
| Metformin 850 mg BID | Change From Baseline in Mean Very Low Density Lipoprotein Particle Size | -0.20 nm | Standard Error 0.612 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.206995% CI: [-2.93, 0.64]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.005295% CI: [0.73, 4.15]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [1.81, 5.36]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration | -4.07 nmol/L | Standard Error 1.434 |
| Pioglitazone 15 mg BID | Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration | -3.01 nmol/L | Standard Error 1.55 |
| Metformin 850 mg BID | Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration | -6.48 nmol/L | Standard Error 1.426 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.61595% CI: [-3.09, 5.21]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.234695% CI: [-6.38, 1.57]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.100195% CI: [-7.61, 0.67]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Medium-Small Low Density Lipoprotein Concentration | -63.8 nmol/L | Standard Error 5.95 |
| Pioglitazone 15 mg BID | Change From Baseline in Medium-Small Low Density Lipoprotein Concentration | -66.0 nmol/L | Standard Error 6.43 |
| Metformin 850 mg BID | Change From Baseline in Medium-Small Low Density Lipoprotein Concentration | -35.3 nmol/L | Standard Error 5.92 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.80495% CI: [-19.4, 15]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000895% CI: [12, 45]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000595% CI: [13.4, 47.8]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration | -1.78 μmol/L | Standard Error 0.349 |
| Pioglitazone 15 mg BID | Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration | -3.41 μmol/L | Standard Error 0.377 |
| Metformin 850 mg BID | Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration | 0.19 μmol/L | Standard Error 0.347 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.001795% CI: [-2.64, -0.62]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [1.01, 2.94]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [2.59, 4.61]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Small Low Density Lipoprotein Concentration | -319.3 nmol/L | Standard Error 28.06 |
| Pioglitazone 15 mg BID | Change From Baseline in Small Low Density Lipoprotein Concentration | -321.3 nmol/L | Standard Error 30.34 |
| Metformin 850 mg BID | Change From Baseline in Small Low Density Lipoprotein Concentration | -179.0 nmol/L | Standard Error 27.91 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.960495% CI: [-83.3, 79.2]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000495% CI: [62.5, 218]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000695% CI: [61.3, 223.3]ANCOVA
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
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration | 3.05 nmol/L | Standard Error 1.249 |
| Pioglitazone 15 mg BID | Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration | 5.9 nmol/L | Standard Error 1.35 |
| Metformin 850 mg BID | Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration | -2.86 nmol/L | Standard Error 1.239 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.121795% CI: [-0.76, 6.48]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000995% CI: [-9.36, -2.44]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-12.36, -5.16]ANCOVA
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.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Total Cholesterol | 1.06 mg/dL | Standard Error 1.183 |
| Pioglitazone 15 mg BID | Change From Baseline in Total Cholesterol | 4.79 mg/dL | Standard Error 1.271 |
| Metformin 850 mg BID | Change From Baseline in Total Cholesterol | -2.72 mg/dL | Standard Error 1.169 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.032495% CI: [0.31, 7.14]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.023395% CI: [-7.05, -0.52]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: <0.000195% CI: [-10.9, -4.12]ANCOVA
Secondary
Change From Baseline in Triglycerides
The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.
Time frame: Baseline and Week 24
Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Triglycerides | -5.95 mg/dL | Standard Error 2.901 |
| Pioglitazone 15 mg BID | Change From Baseline in Triglycerides | -5.54 mg/dL | Standard Error 3.107 |
| Metformin 850 mg BID | Change From Baseline in Triglycerides | -1.78 mg/dL | Standard Error 2.871 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.923195% CI: [-7.94, 8.76]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.308295% CI: [-3.86, 12.19]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.375395% CI: [-4.56, 12.07]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Change From Baseline in Very Small Low Density Lipoprotein Concentration | -255.5 nmol/L | Standard Error 22.37 |
| Pioglitazone 15 mg BID | Change From Baseline in Very Small Low Density Lipoprotein Concentration | -255.2 nmol/L | Standard Error 24.18 |
| Metformin 850 mg BID | Change From Baseline in Very Small Low Density Lipoprotein Concentration | -143.8 nmol/L | Standard Error 22.25 |
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.992295% CI: [-64.4, 65.1]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000495% CI: [49.7, 173.7]ANCOVA
Comparison: One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.p-value: 0.000895% CI: [46.8, 175.9]ANCOVA
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
Time frame: Baseline and Week 24
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pioglitazone 15 mg/Metformin 850 mg BID | Median Percent Change From Baseline in High Sensitivity C-reactive Protein | -36.7 percent | Full Range 4.6719 |
| Pioglitazone 15 mg BID | Median Percent Change From Baseline in High Sensitivity C-reactive Protein | -34.0 percent | Full Range 8.1275 |
| Metformin 850 mg BID | Median Percent Change From Baseline in High Sensitivity C-reactive Protein | -26.2 percent | Full Range 12.5526 |
Comparison: Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.p-value: 0.596395% CI: [-4.71, 13.97]ANCOVA
Comparison: Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.p-value: 0.026595% CI: [2.88, 22.24]ANCOVA
Comparison: Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.p-value: 0.105395% CI: [-1.77, 18.07]ANCOVA