Trial Outcomes & Findings for Study of Rivoglitazone in Type 2 Diabetes Mellitus (NCT NCT00484198)

NCT ID: NCT00484198

Last Updated: 2021-07-27

Results Overview

Percentage of hemoglobin A1c (HbA1c) levels are reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1912 participants

Primary outcome timeframe

Baseline up to week 26 post-dose

Results posted on

2021-07-27

Participant Flow

A total of 1,912 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 254 sites in Africa, Asia, Europe, North America, and South America.

During the 2-week stabilization/washout, single-blind, placebo run-in period, participants were to discontinue any previous therapy with oral anti-hyperglycemic agents and were to self-administer single-blind, double-dummy, placebo medication consisting of over-encapsulated pioglitazone-matching placebo tablets and rivoglitazone-matching placebo tablets once daily.

Participant milestones

Participant milestones
Measure	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. Extension Period: Participants who received Placebo in the base study received Pioglitazone 45 mg once daily for 26-week cycles (Cycle 1 and 2) instead in the extension period.	Rivoglitazone 1.0 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 week cycles (Cycle 1 and 2).	Rivoglitazone 1.5 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks cycles (Cycle 1 and 2).	Pioglitazone 45 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 week cycles (Cycle 1 and Cycle 2).
Overall Study STARTED	137	274	750	751
Overall Study COMPLETED	96	208	599	579
Overall Study NOT COMPLETED	41	66	151	172

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Extension Period: Participants who received Placebo in the base study received Pioglitazone 45 mg once daily for 26-week cycles (Cycle 1 and 2) instead in the extension period.	Rivoglitazone 1.0 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 week cycles (Cycle 1 and 2).	Rivoglitazone 1.5 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks cycles (Cycle 1 and 2).	Pioglitazone 45 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 week cycles (Cycle 1 and Cycle 2).
Overall Study Participant Withdrew Consent	12	21	47	59
Overall Study Hyperglycemia Meeting Discontinuation Criteria	16	17	29	38
Overall Study Therapeutic failure/ lack of efficacy	3	2	6	8
Overall Study Adverse Event	3	11	32	31
Overall Study Protocol Violation	0	5	6	8
Overall Study Other	7	10	31	28

Baseline Characteristics

Study of Rivoglitazone in Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=137 Participants 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.	Rivoglitazone 1.0 mg n=274 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5 mg n=750 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=751 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Total n=1912 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 12.32 • n=5 Participants	55.0 years STANDARD_DEVIATION 10.51 • n=7 Participants	55.1 years STANDARD_DEVIATION 10.59 • n=5 Participants	55.0 years STANDARD_DEVIATION 10.84 • n=4 Participants	55.0 years STANDARD_DEVIATION 10.80 • n=21 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	142 Participants n=7 Participants	368 Participants n=5 Participants	353 Participants n=4 Participants	933 Participants n=21 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	132 Participants n=7 Participants	382 Participants n=5 Participants	398 Participants n=4 Participants	979 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	33 Participants n=5 Participants	59 Participants n=7 Participants	171 Participants n=5 Participants	151 Participants n=4 Participants	414 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	104 Participants n=5 Participants	215 Participants n=7 Participants	579 Participants n=5 Participants	600 Participants n=4 Participants	1498 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	1 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized Asian	42 Participants n=5 Participants	89 Participants n=7 Participants	245 Participants n=5 Participants	243 Participants n=4 Participants	619 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants	35 Participants n=4 Participants	87 Participants n=21 Participants
Race/Ethnicity, Customized White	80 Participants n=5 Participants	147 Participants n=7 Participants	406 Participants n=5 Participants	414 Participants n=4 Participants	1047 Participants n=21 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	18 Participants n=7 Participants	55 Participants n=5 Participants	58 Participants n=4 Participants	142 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to week 26 post-dose

Population: Hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.

Percentage of hemoglobin A1c (HbA1c) levels are reported.

Outcome measures

Outcome measures
Measure	Placebo n=134 Participants 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.	Rivoglitazone 1.0 mg n=266 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=733 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=728 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	7.7 percentage of HbA1c Standard Deviation 0.55	7.7 percentage of HbA1c Standard Deviation 0.54	7.7 percentage of HbA1c Standard Deviation 0.57	7.7 percentage of HbA1c Standard Deviation 0.58
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 Week 26	8.0 percentage of HbA1c Standard Deviation 0.86	7.3 percentage of HbA1c Standard Deviation 0.94	7.1 percentage of HbA1c Standard Deviation 0.83	7.2 percentage of HbA1c Standard Deviation 0.90

PRIMARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Change in hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.

Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=134 Participants 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.	Rivoglitazone 1.0 mg n=266 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=733 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=728 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	0.3 percent change in HbA1c Standard Deviation 0.69	-0.3 percent change in HbA1c Standard Deviation 0.75	-0.6 percent change in HbA1c Standard Deviation 0.72	-0.5 percent change in HbA1c Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline up to week 26 post-dose

Population: Fasting plasma glucose levels were assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants 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.	Rivoglitazone 1.0 mg n=263 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=729 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=721 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	161.1 mg/dL Standard Deviation 44.28	159.2 mg/dL Standard Deviation 42.33	160.9 mg/dL Standard Deviation 40.24	161.9 mg/dL Standard Deviation 42.96
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 Week 26	167.5 mg/dL Standard Deviation 41.23	136.5 mg/dL Standard Deviation 39.73	128.6 mg/dL Standard Deviation 35.06	132.3 mg/dL Standard Deviation 38.32

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Change in fasting plasma glucose levels were assessed in participants with values at both baseline and study endpoint.

The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants 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.	Rivoglitazone 1.0 mg n=263 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=729 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=721 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	6.1 mg/dL Standard Deviation 39.61	-22.1 mg/dL Standard Deviation 34.75	-32.4 mg/dL Standard Deviation 38.48	-29.5 mg/dL Standard Deviation 40.32

SECONDARY outcome

Timeframe: Baseline up to week 26 post-dose

Population: Homeostasis Model Assessment Index was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=104 Participants 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.	Rivoglitazone 1.0 mg n=243 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=690 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=671 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	6.2 score on a scale Standard Deviation 6.98	5.6 score on a scale Standard Deviation 4.64	6.0 score on a scale Standard Deviation 6.65	6.2 score on a scale Standard Deviation 6.92
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 Week 26	6.8 score on a scale Standard Deviation 5.65	4.0 score on a scale Standard Deviation 3.78	3.7 score on a scale Standard Deviation 4.49	4.1 score on a scale Standard Deviation 4.75

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Change in Homeostasis Model Assessment Index was assessed in participants with values for baseline and study endpoint.

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.

Outcome measures

Outcome measures
Measure	Placebo n=104 Participants 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.	Rivoglitazone 1.0 mg n=243 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=690 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=671 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	0.4 score on a scale Standard Deviation 7.56	-1.5 score on a scale Standard Deviation 3.79	-2.3 score on a scale Standard Deviation 5.15	-2.2 score on a scale Standard Deviation 7.56

SECONDARY outcome

Timeframe: Baseline up to week 26 post-dose

Population: Total cholesterol levels were assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=678 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	190.1 mg/dL Standard Deviation 36.23	193.4 mg/dL Standard Deviation 38.27	191.6 mg/dL Standard Deviation 38.80	189.8 mg/dL Standard Deviation 39.42
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 Week 26	191.9 mg/dL Standard Deviation 39.60	198.0 mg/dL Standard Deviation 40.39	199.1 mg/dL Standard Deviation 43.14	194.6 mg/dL Standard Deviation 41.84

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Percent change in total cholesterol levels were assessed in participants with values at baseline and study endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=678 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	1.9 percent change in total cholesterol Standard Deviation 13.01	4.0 percent change in total cholesterol Standard Deviation 17.81	5.3 percent change in total cholesterol Standard Deviation 17.49	3.6 percent change in total cholesterol Standard Deviation 16.31

SECONDARY outcome

Timeframe: Baseline up to Week 26 post-dose

Population: Total triglyceride levels were assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=678 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	185.6 mg/dL Standard Deviation 111.25	173.3 mg/dL Standard Deviation 104.90	169.5 mg/dL Standard Deviation 101.27	175.0 mg/dL Standard Deviation 96.75
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 Week 26	170.5 mg/dL Standard Deviation 99.17	148.0 mg/dL Standard Deviation 91.88	141.0 mg/dL Standard Deviation 84.12	152.1 mg/dL Standard Deviation 112.72

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Percent change in total triglyceride levels were assessed in participants with values at baseline and study endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=678 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	-1.8 percent change in total triglycerides Standard Deviation 26.52	-10.3 percent change in total triglycerides Standard Deviation 32.84	-11.7 percent change in total triglycerides Standard Deviation 34.35	-9.6 percent change in total triglycerides Standard Deviation 45.84

SECONDARY outcome

Timeframe: Baseline up to Week 26 post-dose

Population: Low-density lipoprotein cholesterol levels were assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=674 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	108.5 mg/dL Standard Deviation 29.68	112.8 mg/dL Standard Deviation 32.37	112.1 mg/dL Standard Deviation 32.35	110.5 mg/dL Standard Deviation 33.60
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 Week 26	111.8 mg/dL Standard Deviation 31.37	118.0 mg/dL Standard Deviation 34.19	118.7 mg/dL Standard Deviation 36.99	115.0 mg/dL Standard Deviation 36.03

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Percent change in low-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=674 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	3.4 percent change in LDL Standard Deviation 18.56	9.3 percent change in LDL Standard Deviation 32.91	9.6 percent change in LDL Standard Deviation 30.02	7.3 percent change in LDL Standard Deviation 32.25

SECONDARY outcome

Timeframe: Baseline to Week 26 post-dose

Population: High-density lipoprotein cholesterol was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=675 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	45.3 mg/dL Standard Deviation 11.73	46.0 mg/dL Standard Deviation 12.49	45.8 mg/dL Standard Deviation 11.46	44.7 mg/dL Standard Deviation 10.25
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 Week 26	45.6 mg/dL Standard Deviation 11.46	50.4 mg/dL Standard Deviation 14.84	52.0 mg/dL Standard Deviation 14.72	49.7 mg/dL Standard Deviation 12.65

SECONDARY outcome

Timeframe: Baseline to 26 weeks post-dose

Population: Percent change in high-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.

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.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants 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.	Rivoglitazone 1.0 mg n=246 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=694 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=675 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	2.7 percent change Standard Deviation 14.30	10.3 percent change Standard Deviation 18.15	14.8 percent change Standard Deviation 22.65	12.3 percent change Standard Deviation 21.97

SECONDARY outcome

Timeframe: Baseline to Week 26 post-dose

Population: Apolipoprotein A-I was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants 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.	Rivoglitazone 1.0 mg n=245 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=691 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=677 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	145.3 mg/dL Standard Deviation 25.11	145.7 mg/dL Standard Deviation 27.60	145.2 mg/dL Standard Deviation 24.31	143.6 mg/dL Standard Deviation 22.88
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 Week 26	146.2 mg/dL Standard Deviation 26.39	146.4 mg/dL Standard Deviation 29.52	145.9 mg/dL Standard Deviation 27.37	143.9 mg/dL Standard Deviation 24.97

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Percent change in apolipoprotein A-I was assessed in participants with values at baseline and study endpoint.

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.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants 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.	Rivoglitazone 1.0 mg n=245 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=691 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=677 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	2.0 percent change Standard Deviation 12.22	1.0 percent change Standard Deviation 12.88	0.9 percent change Standard Deviation 13.18	0.8 percent change Standard Deviation 13.09

SECONDARY outcome

Timeframe: Baseline to Week 26 post-dose

Population: Apolipoprotein B was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants 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.	Rivoglitazone 1.0 mg n=245 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=691 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=677 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	112.8 mg/dL Standard Deviation 25.24	116.1 mg/dL Standard Deviation 26.49	114.6 mg/dL Standard Deviation 26.88	114.3 mg/dL Standard Deviation 27.33
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 Week 26	115.3 mg/dL Standard Deviation 26.50	113.6 mg/dL Standard Deviation 28.60	111.5 mg/dL Standard Deviation 30.29	110.3 mg/dL Standard Deviation 28.90

SECONDARY outcome

Timeframe: Baseline up to 26 weeks post-dose

Population: Apolipoprotein B was assessed in participants with values at baseline and study endpoint.

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.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants 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.	Rivoglitazone 1.0 mg n=245 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=691 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=677 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	3.0 percent change Standard Deviation 14.83	-0.4 percent change Standard Deviation 19.46	-1.1 percent change Standard Deviation 21.24	-2.5 percent change Standard Deviation 18.17

SECONDARY outcome

Timeframe: Baseline up to Week 52 post-dose

Population: Hemoglobin A1c levels were assessed using the Study Extension Set.

Percentage of hemoglobin A1c (HbA1c) levels are reported.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants 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.	Rivoglitazone 1.0 mg n=200 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=194 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=27 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus Week 52	7.0 percentage of HbA1c Standard Deviation 0.72	6.9 percentage of HbA1c Standard Deviation 0.60	6.9 percentage of HbA1c Standard Deviation 0.58	7.0 percentage of HbA1c Standard Deviation 0.75
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus Baseline	7.5 percentage of HbA1c Standard Deviation 0.46	7.6 percentage of HbA1c Standard Deviation 0.53	7.6 percentage of HbA1c Standard Deviation 0.51	7.4 percentage of HbA1c Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline up to 52 weeks post-dose

Population: Hemoglobin A1c was assessed in participants with values at baseline and the extension visit at the end of Cycle 1.

Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants 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.	Rivoglitazone 1.0 mg n=65 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=54 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=11 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	-0.5 percent change in HbA1c Standard Deviation 0.69	-0.7 percent change in HbA1c Standard Deviation 0.57	-0.7 percent change in HbA1c Standard Deviation 0.67	-0.4 percent change in HbA1c Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline up to Week 52 post-dose

Population: Fasting plasma glucose (FPG) levels were assessed in participants with available data in the Study Extension Set.

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.

Outcome measures

Outcome measures
Measure	Placebo n=64 Participants 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.	Rivoglitazone 1.0 mg n=200 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=193 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=27 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Baseline	147.4 mg/dL Standard Deviation 32.31	152.8 mg/dL Standard Deviation 32.32	149.0 mg/dL Standard Deviation 36.00	142.5 mg/dL Standard Deviation 27.81
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 Week 52	117.8 mg/dL Standard Deviation 27.93	116.6 mg/dL Standard Deviation 24.12	115.6 mg/dL Standard Deviation 19.04	124.9 mg/dL Standard Deviation 36.92

SECONDARY outcome

Timeframe: Baseline up to 52 weeks post-dose

Population: 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).

The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants 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.	Rivoglitazone 1.0 mg n=48 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=37 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=7 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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	-33.8 mg/dL Standard Deviation 41.48	-34.2 mg/dL Standard Deviation 24.86	-29.5 mg/dL Standard Deviation 31.39	-35.9 mg/dL Standard Deviation 20.75

SECONDARY outcome

Timeframe: Week -2 up to Week 52 post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants 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.	Rivoglitazone 1.0 mg n=269 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Rivoglitazone 1.5mg n=741 Participants Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Pioglitazone 45 mg n=739 Participants Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
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 Weight increased	0 Participants	5 Participants	23 Participants	12 Participants
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 Fluid retention	0 Participants	3 Participants	2 Participants	1 Participants
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 Participants with drug-related TEAEs	15 Participants	50 Participants	144 Participants	134 Participants
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 Gastritis	1 Participants	3 Participants	2 Participants	7 Participants
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 Edema	0 Participants	2 Participants	5 Participants	9 Participants
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 Edema peripheral	1 Participants	14 Participants	46 Participants	46 Participants
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 Pitting edema	0 Participants	6 Participants	10 Participants	13 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 56 other events

Deaths: 0 deaths

Rivoglitazone 1.0 mg

Serious events: 10 serious events

Other events: 131 other events

Deaths: 0 deaths

Rivoglitazone 1.5mg

Serious events: 22 serious events

Other events: 408 other events

Deaths: 0 deaths

Pioglitazone 45 mg

Serious events: 28 serious events

Other events: 374 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place