| Primary | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Percentage of hemoglobin A1c (HbA1c) levels are reported. | Hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set. | Posted | | Mean | Standard Deviation | percentage of HbA1c | | Baseline up to week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG003 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. |
| | Units | Counts |
|---|
| Participants | - OG000134
- OG001266
- OG002733
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG0007.7± 0.55
- OG0017.7± 0.54
- OG0027.7± 0.57
- OG003
|
|
| |
| Primary | Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement. | Change in hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set. | Posted | | Mean | Standard Deviation | percent change in HbA1c | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG003 | Pioglitazone 45 mg |
|
| Secondary | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG. | Fasting plasma glucose levels were assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | |
|
| Secondary | Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG. | Change in fasting plasma glucose levels were assessed in participants with values at both baseline and study endpoint. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | |
|
| Secondary | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome. | Homeostasis Model Assessment Index was assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline up to week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | |
|
| Secondary | Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity. | Change in Homeostasis Model Assessment Index was assessed in participants with values for baseline and study endpoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. |
|
| Secondary | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. | Total cholesterol levels were assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. |
|
| Secondary | Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement. | Percent change in total cholesterol levels were assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change in total cholesterol | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg |
|
| Secondary | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL. | Total triglyceride levels were assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to Week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. |
|
| Secondary | Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement. | Percent change in total triglyceride levels were assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change in total triglycerides | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | |
|
| Secondary | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL. | Low-density lipoprotein cholesterol levels were assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to Week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | |
|
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement. | Percent change in low-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change in LDL | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. |
|
| Secondary | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL. | High-density lipoprotein cholesterol was assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline to Week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | |
|
| Secondary | Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement. | Percent change in high-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. |
|
| Secondary | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL. | Apolipoprotein A-I was assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline to Week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG003 |
|
| Secondary | Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome. | Percent change in apolipoprotein A-I was assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. |
|
| Secondary | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL. | Apolipoprotein B was assessed in participants with available data in the Full Analysis Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline to Week 26 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG003 | Pioglitazone 45 mg |
|
| Secondary | Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome. | Apolipoprotein B was assessed in participants with values at baseline and study endpoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline up to 26 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | |
|
| Secondary | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Percentage of hemoglobin A1c (HbA1c) levels are reported. | Hemoglobin A1c levels were assessed using the Study Extension Set. | Posted | | Mean | Standard Deviation | percentage of HbA1c | | Baseline up to Week 52 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG002 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. | | OG003 | Placebo/Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. |
|
| Secondary | Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement. | Hemoglobin A1c was assessed in participants with values at baseline and the extension visit at the end of Cycle 1. | Posted | | Mean | Standard Deviation | percent change in HbA1c | | Baseline up to 52 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG002 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. | | OG003 | Placebo/ Pioglitazone 45 mg |
|
| Secondary | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG. | Fasting plasma glucose (FPG) levels were assessed in participants with available data in the Study Extension Set. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to Week 52 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG002 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. | | OG003 | Placebo/ Pioglitazone 45 mg |
|
| Secondary | Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG. | Fasting plasma glucose (FPG) was assessed in participants with values at baseline and the extension visit at the end of Cycle 1. Participants who did not have both baseline and Week 52 data were not included in this analysis (n=1 each for Rivoglitazone 1.0 mg and Pioglitazone 45 mg groups). | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to 52 weeks post-dose | | | | ID | Title | Description |
|---|
| OG000 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | | OG002 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. |
|
| Secondary | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication. | Drug-related TEAEs were assessed in the Safety Set which included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. | Posted | | Count of Participants | | Participants | | Week -2 up to Week 52 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. | | OG001 | Rivoglitazone 1.0 mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | | OG002 | Rivoglitazone 1.5mg | |
|