Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pioglitazone and insulin, Pioglitazone and azilsartan, Pioglitazone and atorvastatin, Pioglitazone and Metformin, Pioglitazone and metformin, Pioglitazone and Glimepiride
Pioglitazone · 20 trials · 17 indications
The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation: * Change=\[100%\*(Endpoint value - Baseline Value)/Baseline Value\]
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.
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by \> 20% from pre-methacholine baseline values.
1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.
1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.
Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.
Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.
Regions of the brain related to cognition include the hippocampus and the dorsolateral prefrontal cortex.
| Arm | Type | Description |
|---|---|---|
| Pioglitazone | ACTIVE_COMPARATOR | pioglitazone |
| Placebo | PLACEBO_COMPARATOR | inactive substance |
| Pioglitazone Group | ACTIVE_COMPARATOR | This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level |
| Comparator Group | NO_INTERVENTION | This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone. |
| Pioglitazone 15 mg /Metformin 850 mg BID | EXPERIMENTAL | - |
| Pioglitazone 15 mg BID | ACTIVE_COMPARATOR | - |
| Metformin 850 mg BID | ACTIVE_COMPARATOR | - |
| Pioglitazone 15 mg and Metformin 850 mg BID | EXPERIMENTAL | - |
| Glimepiride 2 mg and Metformin 850 mg BID | ACTIVE_COMPARATOR | - |
| Pioglitazone + Metformin | EXPERIMENTAL | - |
| Metformin | ACTIVE_COMPARATOR | - |
| Pioglitazone 30 mg to 45 mg QD + Glimepiride 2 mg to 4 mg QD | EXPERIMENTAL | - |
| Glimepiride 4 mg to 6 mg QD | ACTIVE_COMPARATOR | - |
| Pioglitazone QD | EXPERIMENTAL | - |
| Glimepiride QD | ACTIVE_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Pioglitazone 15 mg to 45 mg QD | EXPERIMENTAL | - |
| Glyburide 2.5 mg to 15 mg, QD | ACTIVE_COMPARATOR | - |
| Pioglitazone 15 mg or 30 mg QD | EXPERIMENTAL | - |
| Glyburide 5 mg or 10 mg, QD | ACTIVE_COMPARATOR | - |
| Rosiglitazone QD | ACTIVE_COMPARATOR | - |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| sugar pill (placebo) | PLACEBO_COMPARATOR | 1 sugar pill (placebo) taken once daily for 48 weeks. |
| Pioglitazone 30mg QD | EXPERIMENTAL | (and variable insulin therapy) |
| Pioglitazone 15 mg to 30 mg QD | EXPERIMENTAL | - |
| Pioglitazone 15 mg to 30 mg QD + Ramipril 2.5 mg to 5 mg QD | ACTIVE_COMPARATOR | - |
| Ramipril 2.5 mg to 5 mg QD | ACTIVE_COMPARATOR | - |
| Pioglitazone 30 mg to 45 mg QD | EXPERIMENTAL | - |
| Pioglitazone 30mg to 45 mg QD + Atorvastatin 20 mg to 40 mg QD | EXPERIMENTAL | - |
| Atorvastatin 20mg to 40 mg QD | ACTIVE_COMPARATOR | - |
| Pioglitazone 15 mg QD + Azilsartan 5 mg QD | EXPERIMENTAL | - |
| Pioglitazone 15 mg QD + Azilsartan 40 mg QD | EXPERIMENTAL | - |
| Pioglitazone 15 mg QD | ACTIVE_COMPARATOR | - |
| Pioglitazone 45 mg QD + Azilsartan 5 mg QD | EXPERIMENTAL | - |
| Pioglitazone 45 mg QD + Azilsartan 40 mg QD | EXPERIMENTAL | - |
| Pioglitazone 45 mg QD | ACTIVE_COMPARATOR | - |
| Pioglitazone (Dose 1) QD | EXPERIMENTAL | - |
| Pioglitazone (Dose 2) QD | EXPERIMENTAL | - |
| Pioglitazone (Dose 3) QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| pioglitazone | DRUG | a thiazolidinedione drug |
| placebo | DRUG | an inactive substance |
| Pioglitazone and metformin | DRUG | Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks. |
| Metformin | DRUG | Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. |
| Glimepiride and Metformin | DRUG | Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. |
| Pioglitazone and Glimepiride | DRUG | Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 2 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 4 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone 45 mg, tablets, orally, once daily and Glimepiride 4 mg, orally, once daily for up to 20 weeks. |
| Glimepiride | DRUG | Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 4 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 5 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 6 mg, tablets, orally once daily for up to 20 weeks. |
| Glyburide | DRUG | Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks. |
| Rosiglitazone | DRUG | Rosiglitazone 4 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to rosiglitazone 4 mg, capsules, orally, twice daily for up to 12 weeks |
| Pioglitazone and insulin | DRUG | Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks. |
| Insulin | DRUG | Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks. |
| Pioglitazone and ramipril | DRUG | Pioglitazone 15 mg, tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks. |
| Ramipril | DRUG | Pioglitazone placebo-matching tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks. |
| Pioglitazone and atorvastatin | DRUG | Pioglitazone 30 mg, capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increase to: Pioglitazone 45 mg, capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks. |
| Atorvastatin | DRUG | Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increased to Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks. |
| Pioglitazone and azilsartan | DRUG | Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks. |
Inclusion Criteria 1. Ages 40 years or greater at the time of randomization. 2. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization 3. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity...