Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.
Interventions
0.5 mg tablets administered orally, once daily
1.0 mg tablets administered orally, once daily
DRUGplacebo
placebo tablets matching rivoglitazone tablets administered orally, once daily
DRUGpioglitazone HCl
15 mg capsules administered orally, once daily
DRUGpioglitazone HCl 45 mg
45 mg capsules administered orally, once daily
DRUGmetformin
Oral tablets. Rescue medication.
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provided written informed consent at screening. * Diagnosed with type 2 diabetes mellitus. * Glycosylated hemoglobin (A1c) \>7.0% and ≤8.5% at screening. * Male or female ≥18 years of age. * Women of childbearing potential must have been using an adequate method of contraception to avoid pregnancy throughout the study, and for up to 4 weeks after study completion. * Fasting C-peptide level \>0.5 ng/mL at screening. * Currently being treated with a stable dose of an approved non-thiazolidinedione antihyperglycemic medication (including sulfonylureas, meglitinides, insulin secretagogues, metformin, or α-glucosidase inhibitors) given as monotherapy, for at least 3 months prior to screening, and could discontinue that antihyperglycemic medication at Visit 2 (Week -2) and for the duration of the study. OR * Untreated and had not taken any antihyperglycemic agent during the 2 months prior to screening; if not treated with an oral antihyperglycemic agent, the participant was considered by the investigator to have failed diet and exercise modification as the sole treatment for type 2 diabetes mellitus. * Clinically stable in regard to medical conditions other than type 2 diabetes mellitus. * Concomitant medications (other than oral antihyperglycemic agents) were at stable doses for at least 30 days prior to enrollment and were not anticipated to need adjustment during the study period.
Exclusion criteria
* History of type 1 diabetes and/or history of ketoacidosis. * History of long-term (\>2 months) therapy with insulin. * History of prior treatment failure with, or intolerance of, a thiazolidinedione (ie, rosiglitazone, troglitazone, or pioglitazone). * Treatment with a fibrate lipid-lowering agent (eg, fenofibrate, gemfibrozil). * Confirmed repeat fasting glucose (≥2 readings of fasting blood glucose) \>240 mg/dL (13.3 mmol/L) during the 2-week washout/stabilization and placebo run-in period (Period A). * Body mass index (BMI) \>45 kg/m2 at screening. * History of weight loss \>10% over the 3 months prior to screening. * Female participant who was pregnant or breastfeeding. * Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. * Any known history of congestive heart failure prior to screening. * History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening. History of malignancy (except participants who had been disease-free for \>10 years), or whose malignancy was a basal or squamous cell skin carcinoma. Any history of bladder cancer was an exclusion from participation. Women with a history of cervical dysplasia (CIN2 or higher) were to be excluded unless 2 consecutive normal cervical smears had subsequently been recorded prior to enrollment. * Impaired liver function including evidence of acute or chronic hepatitis or liver disease by medical history, clinical signs or symptoms, or laboratory results. * Evidence for ongoing infectious liver disease with positive hepatitis A antigen or immunoglobulin M antibody, hepatitis B surface antigen, or antibodies to hepatitis C virus. Participants with normal liver function tests and isolated positive antibodies to hepatitis B virus could have been included. * Known (or evidence of) infection with human immunodeficiency virus. * Known hemoglobinopathy or chronic anemia that required specific treatment within 5 years of the screening visit. * History of alcohol or drug abuse within 1 year prior to screening. * History of unstable major psychiatric disorders. Known or suspected allergy or hypersensitivity to thiazolidinedione agents. * Clinically significant abnormalities in any pre-randomization laboratory analyses that, in the investigator's opinion, comprised an undue risk with the participant's participation, or could potentially confound results of the study. Unexplained hematuria (\>3 red blood cells per high-powered field by urine microscopy). * Blood donation of ≥1 pint (0.5 liter) within the past 30 days prior to screening or plasma donation within 7 days prior to the screening visit (Visit 1). * Prior known or possible exposure to rivoglitazone. * Contraindication to treatment with pioglitazone once daily. * Known or suspected allergy, hypersensitivity, or intolerance to the excipients of the investigational study medication. * Participation in an interventional medical, surgical, or pharmaceutical study within 30 days prior to the screening visit (Visit 1). * Any condition or concomitant therapy that, in the opinion of the investigator, might have posed a risk to the participant or made participation not in the participant's best interest. * A direct or familial relationship with the Sponsor, investigator, or site personnel affiliated with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose. | Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | 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. |
| Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | 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. |
| Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | 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 improvement. |
| Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | 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 improvement. |
| Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered bad cholesterol, so a lower score (negative change) means improvement. |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered bad cholesterol, so a lower score (negative change) means improvement. |
| Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose. | Normal fasting plasma glucose (FPG) -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline and a lower FPG means improvement. |
| Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered good cholesterol, so a higher score (positive change) means improvement. |
| Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel. |
| Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel. |
| Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel. |
| Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel. |
| Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 26 post-dose, approximately a total of 27 weeks. | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication. |
| Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 12 post-dose. | High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered good cholesterol, so a higher score (positive change) means improvement. |
Countries
United States
Participant flow
Recruitment details
A total of 94 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 73 clinic sites in the United States of America and 22 in India.
Pre-assignment details
Participants with type 2 diabetes mellitus who were either untreated (ie, not receiving antihyperglycemic medication within at least 2 months prior to screening) or were treated with a single, non-thiazolidinedione agent as monotherapy without adequate glycemic control were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks. | 3 |
| Rivoglitazone 0.5mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks. | 9 |
| Rivoglitazone 1.0mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. | 12 |
| Rivoglitazone 1.5mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. | 27 |
| Pioglitazone 15 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. | 9 |
| Pioglitazone 30 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. | 10 |
| Pioglitazone 45 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. | 24 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Hyperglycemia meeting discontinuation criteria | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Per medical monitor regarding thyroid-stimulating hormone level | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Subject withdrew consent | 0 | 1 | 0 | 2 | 1 | 1 | 2 |
| Overall Study | Termination of study by Sponsor | 2 | 7 | 10 | 24 | 8 | 9 | 22 |
| Overall Study | Therapeutic failure/lack of efficacy | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Rivoglitazone 0.5mg | Rivoglitazone 1.0mg | Rivoglitazone 1.5mg | Pioglitazone 15 mg | Pioglitazone 30 mg | Pioglitazone 45 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 11.36 | 55.1 years STANDARD_DEVIATION 13.03 | 58.3 years STANDARD_DEVIATION 10.86 | 59.4 years STANDARD_DEVIATION 10.46 | 57.0 years STANDARD_DEVIATION 9.85 | 58.5 years STANDARD_DEVIATION 7.71 | 58.0 years STANDARD_DEVIATION 11.72 | 58.1 years STANDARD_DEVIATION 10.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 8 Participants | 24 Participants | 7 Participants | 6 Participants | 22 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 6 Participants | 0 Participants | 2 Participants | 8 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 1 Participants | 8 Participants | 9 Participants | 18 Participants | 8 Participants | 7 Participants | 12 Participants | 63 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 5 Participants | 16 Participants | 4 Participants | 6 Participants | 9 Participants | 43 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 7 Participants | 11 Participants | 5 Participants | 4 Participants | 15 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 9 | 0 / 12 | 0 / 27 | 0 / 8 | 0 / 10 | 0 / 24 |
| other Total, other adverse events | 0 / 3 | 5 / 9 | 1 / 12 | 8 / 27 | 4 / 8 | 2 / 10 | 10 / 24 |
| serious Total, serious adverse events | 0 / 3 | 0 / 9 | 0 / 12 | 0 / 27 | 0 / 8 | 0 / 10 | 0 / 24 |
Outcome results
Primary
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%.
Time frame: Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.
Population: Change in A1c was assessed using the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 8.6 percentage of A1c | — |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.1 percentage of A1c | Standard Deviation 0.28 |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.8 percentage of A1c | Standard Deviation 1.06 |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.8 percentage of A1c | Standard Deviation 0.55 |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | 0.2 percentage of A1c | — |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 8.2 percentage of A1c | Standard Deviation 0.87 |
| Placebo | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.3 percentage of A1c | Standard Deviation 0.67 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 7.2 percentage of A1c | Standard Deviation 0.92 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | 0.2 percentage of A1c | Standard Deviation 0.49 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 7.7 percentage of A1c | — |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | 0.7 percentage of A1c | — |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.7 percentage of A1c | — |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.5 percentage of A1c | Standard Deviation 0.41 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | 0.0 percentage of A1c | Standard Deviation 0.48 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | 0.7 percentage of A1c | — |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.6 percentage of A1c | Standard Deviation 0.54 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | 0.3 percentage of A1c | Standard Deviation 0.61 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.1 percentage of A1c | Standard Deviation 0.23 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.2 percentage of A1c | Standard Deviation 0.62 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | 0.0 percentage of A1c | Standard Deviation 1.13 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.6 percentage of A1c | Standard Deviation 0.86 |
| Rivoglitazone 0.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.7 percentage of A1c | Standard Deviation 0.99 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -0.9 percentage of A1c | — |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.1 percentage of A1c | Standard Deviation 0.32 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.2 percentage of A1c | — |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.4 percentage of A1c | Standard Deviation 0.42 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -0.5 percentage of A1c | Standard Deviation 0.53 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.1 percentage of A1c | Standard Deviation 0.54 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 7.2 percentage of A1c | Standard Deviation 0 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.2 percentage of A1c | Standard Deviation 0.25 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of A1c | Standard Deviation 0.67 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.4 percentage of A1c | Standard Deviation 0.39 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.9 percentage of A1c | Standard Deviation 0.96 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.4 percentage of A1c | Standard Deviation 0.23 |
| Rivoglitazone 1.0mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | -0.7 percentage of A1c | Standard Deviation 0.28 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.0 percentage of A1c | Standard Deviation 0.54 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -0.2 percentage of A1c | Standard Deviation 0.37 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 7.2 percentage of A1c | Standard Deviation 0.4 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.5 percentage of A1c | Standard Deviation 0.46 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.6 percentage of A1c | Standard Deviation 0.49 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.1 percentage of A1c | Standard Deviation 0.3 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.2 percentage of A1c | Standard Deviation 0.52 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.5 percentage of A1c | Standard Deviation 0.56 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | -0.3 percentage of A1c | Standard Deviation 0.37 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.0 percentage of A1c | Standard Deviation 0.43 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.3 percentage of A1c | Standard Deviation 0.55 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -0.2 percentage of A1c | Standard Deviation 0.29 |
| Rivoglitazone 1.5mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.1 percentage of A1c | Standard Deviation 0.41 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | 0.0 percentage of A1c | Standard Deviation 0.78 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.4 percentage of A1c | Standard Deviation 0.68 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 7.6 percentage of A1c | Standard Deviation 0.71 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | -0.2 percentage of A1c | Standard Deviation 0.27 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.2 percentage of A1c | Standard Deviation 0.44 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.6 percentage of A1c | Standard Deviation 0.61 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -0.2 percentage of A1c | Standard Deviation 0.29 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.6 percentage of A1c | Standard Deviation 0.76 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.2 percentage of A1c | Standard Deviation 0.18 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of A1c | Standard Deviation 0.56 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.0 percentage of A1c | Standard Deviation 0.32 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.6 percentage of A1c | Standard Deviation 0.68 |
| Pioglitazone 15 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | -0.1 percentage of A1c | Standard Deviation 0.23 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.5 percentage of A1c | Standard Deviation 0.43 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -0.2 percentage of A1c | Standard Deviation 0.42 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 20 | -0.6 percentage of A1c | — |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.5 percentage of A1c | Standard Deviation 0.51 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.1 percentage of A1c | Standard Deviation 0.19 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.4 percentage of A1c | Standard Deviation 0.56 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.1 percentage of A1c | Standard Deviation 0.27 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.2 percentage of A1c | Standard Deviation 0.65 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.2 percentage of A1c | Standard Deviation 0.46 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.2 percentage of A1c | Standard Deviation 0.54 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 6.8 percentage of A1c | Standard Deviation 0.7 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | -0.4 percentage of A1c | Standard Deviation 0.76 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.0 percentage of A1c | Standard Deviation 0.39 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -0.1 percentage of A1c | Standard Deviation 0.44 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 6.9 percentage of A1c | Standard Deviation 0 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | -0.4 percentage of A1c | Standard Deviation 0.35 |
| Pioglitazone 30 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 20 | 7.0 percentage of A1c | — |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -0.0 percentage of A1c | Standard Deviation 0.37 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 7.6 percentage of A1c | Standard Deviation 0.62 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change in Baseline to Week 2 | 0.1 percentage of A1c | Standard Deviation 0.31 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 7.7 percentage of A1c | Standard Deviation 0.56 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -0.3 percentage of A1c | Standard Deviation 0.47 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 7.0 percentage of A1c | Standard Deviation 0.92 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 7.4 percentage of A1c | Standard Deviation 0.73 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.6 percentage of A1c | Standard Deviation 0.5 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 20 | 7.4 percentage of A1c | Standard Deviation 0.49 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 20 | -0.6 percentage of A1c | Standard Deviation 0.42 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -0.8 percentage of A1c | Standard Deviation 0.5 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | -0.8 percentage of A1c | Standard Deviation 0.67 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 10 | 7.2 percentage of A1c | Standard Deviation 0.93 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.2 percentage of A1c | Standard Deviation 0.44 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 7.5 percentage of A1c | Standard Deviation 0.73 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 7.4 percentage of A1c | Standard Deviation 0.6 |
| Pioglitazone 45 mg | Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 10 | -0.3 percentage of A1c | Standard Deviation 0.58 |
Secondary
Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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. Apo A-I was measured as part of the fasting lipid panel.
Time frame: Baseline up to week 12 post-dose.
Population: Apolipoprotein (Apo) A-I was assessed from the Full Analysis Set. There were instances of zero (0) numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination and were not reported in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 134.0 mg/dL | Standard Deviation 7.57 |
| Rivoglitazone 0.5mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 146.7 mg/dL | Standard Deviation 15.68 |
| Rivoglitazone 0.5mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 144.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 139.7 mg/dL | Standard Deviation 16.2 |
| Rivoglitazone 1.0mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 141.0 mg/dL | — |
| Rivoglitazone 1.5mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 149.8 mg/dL | Standard Deviation 21.08 |
| Rivoglitazone 1.5mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 142.4 mg/dL | Standard Deviation 27.72 |
| Pioglitazone 15 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 133.0 mg/dL | Standard Deviation 20.34 |
| Pioglitazone 15 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 145.3 mg/dL | Standard Deviation 34.27 |
| Pioglitazone 30 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 158.6 mg/dL | Standard Deviation 31.57 |
| Pioglitazone 30 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 153.0 mg/dL | Standard Deviation 24.14 |
| Pioglitazone 45 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 158.2 mg/dL | Standard Deviation 31.44 |
| Pioglitazone 45 mg | Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 149.6 mg/dL | Standard Deviation 25.89 |
Secondary
Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.
Time frame: Baseline up to week 12 post-dose.
Population: Apolipoprotein (Apo) B was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 94.0 mg/dL | Standard Deviation 26.44 |
| Rivoglitazone 0.5mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 206.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 119.1 mg/dL | Standard Deviation 36.53 |
| Rivoglitazone 1.0mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 115.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 121.9 mg/dL | Standard Deviation 36.37 |
| Rivoglitazone 1.5mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 76.5 mg/dL | Standard Deviation 17.06 |
| Rivoglitazone 1.5mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 101.3 mg/dL | Standard Deviation 29.72 |
| Pioglitazone 15 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 105.5 mg/dL | Standard Deviation 34.32 |
| Pioglitazone 15 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 77.7 mg/dL | Standard Deviation 31.53 |
| Pioglitazone 30 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 113.4 mg/dL | Standard Deviation 25.2 |
| Pioglitazone 30 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 120.8 mg/dL | Standard Deviation 15.46 |
| Pioglitazone 45 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 95.6 mg/dL | Standard Deviation 23.39 |
| Pioglitazone 45 mg | Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 108.4 mg/dL | Standard Deviation 31.94 |
Secondary
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Normal fasting plasma glucose (FPG) -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline and a lower FPG means improvement.
Time frame: Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose.
Population: Fasting Plasma Glucose was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 210.0 mg/dL | Standard Deviation 71.51 |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | 31.0 mg/dL | — |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 157.5 mg/dL | Standard Deviation 37.48 |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 218.7 mg/dL | Standard Deviation 48.09 |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 218.0 mg/dL | — |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -8.7 mg/dL | Standard Deviation 41.59 |
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -33.5 mg/dL | Standard Deviation 43.13 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 159.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 157.8 mg/dL | Standard Deviation 48.45 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -0.2 mg/dL | Standard Deviation 23.7 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 158.4 mg/dL | Standard Deviation 54.77 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 153.6 mg/dL | Standard Deviation 56.44 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | 12.2 mg/dL | Standard Deviation 32.89 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -1.0 mg/dL | Standard Deviation 20.06 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 149.4 mg/dL | Standard Deviation 55.44 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | 16.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 142.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 164.1 mg/dL | Standard Deviation 45.09 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -8.3 mg/dL | Standard Deviation 12.5 |
| Rivoglitazone 0.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | 33.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 129.5 mg/dL | Standard Deviation 15.35 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -30.8 mg/dL | Standard Deviation 22.22 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 160.1 mg/dL | Standard Deviation 34.34 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 149.8 mg/dL | Standard Deviation 49.38 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -51.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -10.5 mg/dL | Standard Deviation 36.05 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 128.6 mg/dL | Standard Deviation 33.31 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -41.3 mg/dL | Standard Deviation 26.29 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -24.6 mg/dL | Standard Deviation 30.97 |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 131.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 126.5 mg/dL | Standard Deviation 24.14 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 125.0 mg/dL | Standard Deviation 15.7 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -32.5 mg/dL | Standard Deviation 25.38 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 162.2 mg/dL | Standard Deviation 42.37 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 120.3 mg/dL | Standard Deviation 11.79 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -26.2 mg/dL | Standard Deviation 27.69 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 126.9 mg/dL | Standard Deviation 17.76 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -13.6 mg/dL | Standard Deviation 33.75 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -41.1 mg/dL | Standard Deviation 33.09 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 145.6 mg/dL | Standard Deviation 35.32 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 152.4 mg/dL | Standard Deviation 50.06 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -35.1 mg/dL | Standard Deviation 20.51 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 173.3 mg/dL | Standard Deviation 35.77 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 160.8 mg/dL | Standard Deviation 21.12 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -12.5 mg/dL | Standard Deviation 22.48 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 171.4 mg/dL | Standard Deviation 48.23 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -1.9 mg/dL | Standard Deviation 38.79 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 174.3 mg/dL | Standard Deviation 41.8 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | 0.7 mg/dL | Standard Deviation 48.65 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 149.2 mg/dL | Standard Deviation 35.72 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -23.2 mg/dL | Standard Deviation 57.14 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 131.7 mg/dL | Standard Deviation 13.43 |
| Pioglitazone 15 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -25.3 mg/dL | Standard Deviation 18.58 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 20 | 107.0 mg/dL | — |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | 7.6 mg/dL | Standard Deviation 41.71 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | 2.3 mg/dL | Standard Deviation 20.34 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -9.8 mg/dL | Standard Deviation 25.08 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 145.6 mg/dL | Standard Deviation 49.47 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 138.3 mg/dL | Standard Deviation 22.89 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 111.0 mg/dL | Standard Deviation 2.83 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 20 | -25.0 mg/dL | — |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 140.9 mg/dL | Standard Deviation 19.43 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | -19.5 mg/dL | Standard Deviation 4.95 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 122.3 mg/dL | Standard Deviation 13.23 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -4.0 mg/dL | Standard Deviation 12.51 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 140.3 mg/dL | Standard Deviation 30.49 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | 2.6 mg/dL | Standard Deviation 16.93 |
| Pioglitazone 30 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 134.0 mg/dL | Standard Deviation 25 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 2 | 144.7 mg/dL | Standard Deviation 34.46 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 8 | 148.3 mg/dL | Standard Deviation 34.55 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 4 | 143.6 mg/dL | Standard Deviation 26.4 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 20 | 124.0 mg/dL | Standard Deviation 15.56 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 8 | -20.0 mg/dL | Standard Deviation 28.27 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 2 | -13.8 mg/dL | Standard Deviation 24.11 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 126.4 mg/dL | Standard Deviation 27.77 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 4 | -20.0 mg/dL | Standard Deviation 24.2 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 158.5 mg/dL | Standard Deviation 35.45 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 20 | -18.0 mg/dL | Standard Deviation 1.41 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 12 | -29.4 mg/dL | Standard Deviation 20.5 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 16 | 133.7 mg/dL | Standard Deviation 22.19 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 16 | -39.3 mg/dL | Standard Deviation 51.78 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline to Week 6 | -17.1 mg/dL | Standard Deviation 41.99 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 6 | 146.8 mg/dL | Standard Deviation 44.22 |
Secondary
Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered good cholesterol, so a higher score (positive change) means improvement.
Time frame: Baseline up to week 12 post-dose.
Population: High-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 40.2 mg/dL | Standard Deviation 2.31 |
| Rivoglitazone 0.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | -1.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 49.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 43.9 mg/dL | Standard Deviation 10.84 |
| Rivoglitazone 1.0mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | 5.9 mg/dL | — |
| Rivoglitazone 1.0mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 42.4 mg/dL | Standard Deviation 9.23 |
| Rivoglitazone 1.0mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 45.0 mg/dL | — |
| Rivoglitazone 1.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 44.3 mg/dL | Standard Deviation 13.7 |
| Rivoglitazone 1.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | 13.1 mg/dL | Standard Deviation 14.03 |
| Rivoglitazone 1.5mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 52.8 mg/dL | Standard Deviation 11.53 |
| Pioglitazone 15 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | 12.9 mg/dL | Standard Deviation 12.93 |
| Pioglitazone 15 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 42.5 mg/dL | Standard Deviation 10.87 |
| Pioglitazone 15 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 52.3 mg/dL | Standard Deviation 21.01 |
| Pioglitazone 30 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 51.3 mg/dL | Standard Deviation 10.14 |
| Pioglitazone 30 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | 10.8 mg/dL | Standard Deviation 10.26 |
| Pioglitazone 30 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 49.4 mg/dL | Standard Deviation 14.23 |
| Pioglitazone 45 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Change from Baseline Week 12 | 11.1 mg/dL | Standard Deviation 10.39 |
| Pioglitazone 45 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 56.6 mg/dL | Standard Deviation 14.43 |
| Pioglitazone 45 mg | Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 47.2 mg/dL | Standard Deviation 11.86 |
Secondary
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered bad cholesterol, so a lower score (negative change) means improvement.
Time frame: Baseline up to week 12 post-dose.
Population: Low-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 101.7 mg/dL | Standard Deviation 33.9 |
| Rivoglitazone 0.5mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 226.0 mg/dL | — |
| Rivoglitazone 0.5mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 124.1 mg/dL | Standard Deviation 45.67 |
| Rivoglitazone 1.0mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 112.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 125.8 mg/dL | Standard Deviation 53.79 |
| Rivoglitazone 1.5mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 95.9 mg/dL | Standard Deviation 28.52 |
| Rivoglitazone 1.5mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 78.5 mg/dL | Standard Deviation 20.7 |
| Pioglitazone 15 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 95.7 mg/dL | Standard Deviation 22.73 |
| Pioglitazone 15 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 82.7 mg/dL | Standard Deviation 45.54 |
| Pioglitazone 30 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 129.8 mg/dL | Standard Deviation 10.56 |
| Pioglitazone 30 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 105.8 mg/dL | Standard Deviation 35.12 |
| Pioglitazone 45 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 108.4 mg/dL | Standard Deviation 41.93 |
| Pioglitazone 45 mg | Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 111.6 mg/dL | Standard Deviation 24.67 |
Secondary
Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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.
Time frame: Baseline up to week 12 post-dose.
Population: Total cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 162.2 mg/dL | Standard Deviation 38.1 |
| Rivoglitazone 0.5mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 211.3 mg/dL | Standard Deviation 52.87 |
| Rivoglitazone 0.5mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 311.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 204.9 mg/dL | Standard Deviation 63.66 |
| Rivoglitazone 1.0mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 193.0 mg/dL | — |
| Rivoglitazone 1.5mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 145.8 mg/dL | Standard Deviation 17.27 |
| Rivoglitazone 1.5mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 171.6 mg/dL | Standard Deviation 38.95 |
| Pioglitazone 15 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 172.1 mg/dL | Standard Deviation 35.49 |
| Pioglitazone 15 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 151.3 mg/dL | Standard Deviation 47.08 |
| Pioglitazone 30 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 201.7 mg/dL | Standard Deviation 50.13 |
| Pioglitazone 30 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 213.3 mg/dL | Standard Deviation 28.62 |
| Pioglitazone 45 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 186.6 mg/dL | Standard Deviation 36.19 |
| Pioglitazone 45 mg | Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 188.1 mg/dL | Standard Deviation 47.45 |
Secondary
Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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 improvement.
Time frame: Baseline up to week 12 post-dose.
Population: Total Triglycerides were assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 100.8 mg/dL | Standard Deviation 15.94 |
| Rivoglitazone 0.5mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 293.2 mg/dL | Standard Deviation 300.5 |
| Rivoglitazone 0.5mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 179.0 mg/dL | — |
| Rivoglitazone 1.0mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 214.8 mg/dL | Standard Deviation 145.63 |
| Rivoglitazone 1.0mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 180.0 mg/dL | — |
| Rivoglitazone 1.5mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 72.0 mg/dL | Standard Deviation 6.73 |
| Rivoglitazone 1.5mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 156.5 mg/dL | Standard Deviation 85.96 |
| Pioglitazone 15 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 165.7 mg/dL | Standard Deviation 118.31 |
| Pioglitazone 15 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 82.3 mg/dL | Standard Deviation 44.52 |
| Pioglitazone 30 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 221.0 mg/dL | Standard Deviation 188.82 |
| Pioglitazone 30 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 161.3 mg/dL | Standard Deviation 100.69 |
| Pioglitazone 45 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 12 | 90.8 mg/dL | Standard Deviation 41.95 |
| Pioglitazone 45 mg | Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 163.0 mg/dL | Standard Deviation 72.29 |
Secondary
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone 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 randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
Time frame: Baseline up to week 26 post-dose, approximately a total of 27 weeks.
Population: Treatment-emergent adverse events were assessed from the Safety Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 1 Participants |
| Rivoglitazone 0.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 1 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 1 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Rivoglitazone 1.0mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 2 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 1 Participants |
| Rivoglitazone 1.5mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 1 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 0 Participants |
| Pioglitazone 15 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 1 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 1 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 1 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 1 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Lymphadenitis | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Sinusitis | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Stomach Discomfort | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal pain | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back injury | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Ocular Hyperaemia | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Bronchitis | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Musculoskeletal stiffness | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Arthropod bite | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pharyngolaryngeal pain | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Furuncle | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Myalgia | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Eye Pruritus | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Mood altered | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pain in extremity | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Conjunctivitis | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Malaise | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nasopharyngitis | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Carpal tunnel syndrome | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Influenza | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Viral upper respiratory tract infection | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Rash | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dizziness | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypothyroidism | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fungal infection | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema peripheral | 2 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Headache | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Upper respiratory tract | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Insomnia | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Muscle twitching | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hypertension | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flatulence | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Red blood cell morphology abnormal | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Non-cardiac chest pain | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Oedema | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Haemoglobin decreased | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Back pain | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Dry Mouth | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Seasonal allergy | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Flank pain | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Cholelithiasis | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Hyperhidrosis | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Nausea | 1 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Joint crepitation | 0 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Blood creatine phosphokinase increased | 2 Participants |
| Pioglitazone 45 mg | Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | Abdominal Pain | 0 Participants |
Secondary
Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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. Apo A-I was measured as part of the fasting lipid panel.
Time frame: Baseline up to week 12 post-dose.
Population: Apolipoprotein (Apo) A-I was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -14.5 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -2.8 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 2.8 percent change | Standard Deviation 9.18 |
| Pioglitazone 15 mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 3.0 percent change | Standard Deviation 6.9 |
| Pioglitazone 30 mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.3 percent change | Standard Deviation 6.81 |
| Pioglitazone 45 mg | Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 1.4 percent change | Standard Deviation 10.19 |
Secondary
Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.
Time frame: Baseline up to week 12 post-dose.
Population: Apolipoprotein (Apo) B was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 13.2 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -12.2 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -11.5 percent change | Standard Deviation 5.21 |
| Pioglitazone 15 mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -14.8 percent change | Standard Deviation 20.97 |
| Pioglitazone 30 mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.1 percent change | Standard Deviation 6.63 |
| Pioglitazone 45 mg | Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 1.7 percent change | Standard Deviation 16.2 |
Secondary
Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered good cholesterol, so a higher score (positive change) means improvement.
Time frame: Baseline up to week 12 post-dose.
Population: High-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.0 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 5.9 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 13.1 percent change | Standard Deviation 14.03 |
| Pioglitazone 15 mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 12.9 percent change | Standard Deviation 12.93 |
| Pioglitazone 30 mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 10.8 percent change | Standard Deviation 10.26 |
| Pioglitazone 45 mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 11.1 percent change | Standard Deviation 10.39 |
Secondary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered bad cholesterol, so a lower score (negative change) means improvement.
Time frame: Baseline up to week 12 post-dose.
Population: Low-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 16.8 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.8 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -8.6 percent change | Standard Deviation 3.25 |
| Pioglitazone 15 mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -5.7 percent change | Standard Deviation 18.7 |
| Pioglitazone 30 mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 14.5 percent change | Standard Deviation 1.15 |
| Pioglitazone 45 mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 14.0 percent change | Standard Deviation 18.48 |
Secondary
Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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.
Time frame: Baseline up to week 12 post-dose.
Population: Total cholesterol was assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 8.9 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -8.5 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -2.2 percent change | Standard Deviation 6.46 |
| Pioglitazone 15 mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.6 percent change | Standard Deviation 9.54 |
| Pioglitazone 30 mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 2.7 percent change | Standard Deviation 15.73 |
| Pioglitazone 45 mg | Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | 7.4 percent change | Standard Deviation 15.6 |
Secondary
Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone 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 improvement.
Time frame: Baseline up to week 12 post-dose.
Population: Total Triglycerides were assessed from the Full Analysis Set. There were 0 numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoglitazone 0.5mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -15.4 percent change | — |
| Rivoglitazone 1.0mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -34.1 percent change | — |
| Rivoglitazone 1.5mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -16.8 percent change | Standard Deviation 16.17 |
| Pioglitazone 15 mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -20.5 percent change | Standard Deviation 40.04 |
| Pioglitazone 30 mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -16.1 percent change | Standard Deviation 24.8 |
| Pioglitazone 45 mg | Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus | -16.2 percent change | Standard Deviation 33.6 |