Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus
Brief summary
This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.
Interventions
DRUGPioglitazone
45 mg over-encapsulated tablet administered orally, once daily
DRUGPlacebo
Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
DRUGRivoglitazone
1.0 mg tablet administered orally, once daily
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
* Diagnosis of type 2 diabetes * Male or female at least 18 years of age * Hemoglobin A1C \> 7% and less or equal to 8.5% * Non-fasting C-peptide \> 0.5 ng/mL * Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or * Untreated with any antihyperglycemic agent during 2 months prior to screening
Exclusion criteria
* History of type 1 diabetes or ketoacidosis * History of long-term therapy with insulin * Body Mass Index (BMI) \> 45 kg/m\^2 * Known history of Congestive Heart Failure (CHF) * Impaired hepatic function * History of prior treatment failure with, or intolerance of, a TZD * Contraindication to treatment with pioglitazone * Treatment with fibrates * If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 26 post-dose | Percentage of hemoglobin A1c (HbA1c) levels are reported. |
| Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 26 post-dose | Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered borderline high, and HOMA-IR scores \>3.80 are considered high and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome. |
| Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 52 weeks post-dose | Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement. |
| Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered borderline high, and HOMA-IR scores \>3.80 are considered high and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity. |
| Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 26 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 to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks 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. Higher percent change in total cholesterol indicates better outcome, ie. improvement. |
| Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to Week 26 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. Normal triglyceride levels are below 150 mg/dL. |
| Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks 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 better outcome, ie. improvement. |
| Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to Week 26 post-dose | Low-density lipoprotein cholesterol (LDL-C), bad cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are \<100 mg/dL. |
| Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | Low-density lipoprotein cholesterol (LDL-C), bad cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement. |
| Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to week 26 post-dose | Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG. |
| Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline to 26 weeks post-dose | High-density lipoprotein cholesterol (HDL-C), good cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement. |
| Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline to Week 26 post-dose | Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL. |
| Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome. |
| Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline to Week 26 post-dose | Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are \<100 mg/dL. |
| Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome. |
| Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to Week 52 post-dose | Percentage of hemoglobin A1c (HbA1c) levels are reported. |
| Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to Week 52 post-dose | Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG. |
| Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 52 weeks post-dose | The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG. |
| Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week -2 up to Week 52 post-dose | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication. |
| High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline to Week 26 post-dose | High-density lipoprotein cholesterol (HDL-C), good cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are \>40 mg/dL. |
| Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline up to 26 weeks post-dose | The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG. |
Countries
Argentina, Austria, Chile, Czechia, Germany, Hungary, India, Latvia, Mexico, Peru, Puerto Rico, Romania, Serbia, Slovakia, South Africa, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 1,912 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 254 sites in Africa, Asia, Europe, North America, and South America.
Pre-assignment details
During the 2-week stabilization/washout, single-blind, placebo run-in period, participants were to discontinue any previous therapy with oral anti-hyperglycemic agents and were to self-administer single-blind, double-dummy, placebo medication consisting of over-encapsulated pioglitazone-matching placebo tablets and rivoglitazone-matching placebo tablets once daily.
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 over-encapsulated tablet once daily for 26 weeks. | 137 |
| Rivoglitazone 1.0 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. | 274 |
| Rivoglitazone 1.5 mg Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. | 750 |
| Pioglitazone 45 mg Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. | 751 |
| Total | 1,912 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 11 | 32 | 31 |
| Overall Study | Hyperglycemia Meeting Discontinuation Criteria | 16 | 17 | 29 | 38 |
| Overall Study | Other | 7 | 10 | 31 | 28 |
| Overall Study | Participant Withdrew Consent | 12 | 21 | 47 | 59 |
| Overall Study | Protocol Violation | 0 | 5 | 6 | 8 |
| Overall Study | Therapeutic failure/ lack of efficacy | 3 | 2 | 6 | 8 |
Baseline characteristics
| Characteristic | Rivoglitazone 1.5 mg | Total | Pioglitazone 45 mg | Placebo | Rivoglitazone 1.0 mg |
|---|---|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 10.59 | 55.0 years STANDARD_DEVIATION 10.8 | 55.0 years STANDARD_DEVIATION 10.84 | 55.4 years STANDARD_DEVIATION 12.32 | 55.0 years STANDARD_DEVIATION 10.51 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 11 Participants | 17 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 245 Participants | 619 Participants | 243 Participants | 42 Participants | 89 Participants |
| Race/Ethnicity, Customized Black or African American | 33 Participants | 87 Participants | 35 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 171 Participants | 414 Participants | 151 Participants | 33 Participants | 59 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 579 Participants | 1498 Participants | 600 Participants | 104 Participants | 215 Participants |
| Race/Ethnicity, Customized Other | 55 Participants | 142 Participants | 58 Participants | 11 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 406 Participants | 1047 Participants | 414 Participants | 80 Participants | 147 Participants |
| Sex: Female, Male Female | 368 Participants | 933 Participants | 353 Participants | 70 Participants | 142 Participants |
| Sex: Female, Male Male | 382 Participants | 979 Participants | 398 Participants | 67 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 269 | 0 / 741 | 2 / 739 |
| other Total, other adverse events | 56 / 137 | 131 / 269 | 408 / 741 | 374 / 739 |
| serious Total, serious adverse events | 3 / 137 | 10 / 269 | 22 / 741 | 28 / 739 |
Outcome results
Primary
Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Time frame: Baseline up to 26 weeks post-dose
Population: Change in hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.3 percent change in HbA1c | Standard Deviation 0.69 |
| Rivoglitazone 1.0 mg | Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.3 percent change in HbA1c | Standard Deviation 0.75 |
| Rivoglitazone 1.5mg | Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.6 percent change in HbA1c | Standard Deviation 0.72 |
| Pioglitazone 45 mg | Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.5 percent change in HbA1c | Standard Deviation 0.77 |
Primary
Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Time frame: Baseline up to week 26 post-dose
Population: Hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of HbA1c | Standard Deviation 0.55 |
| Placebo | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 8.0 percentage of HbA1c | Standard Deviation 0.86 |
| Rivoglitazone 1.0 mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 7.3 percentage of HbA1c | Standard Deviation 0.94 |
| Rivoglitazone 1.0 mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of HbA1c | Standard Deviation 0.54 |
| Rivoglitazone 1.5mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of HbA1c | Standard Deviation 0.57 |
| Rivoglitazone 1.5mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 7.1 percentage of HbA1c | Standard Deviation 0.83 |
| Pioglitazone 45 mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.7 percentage of HbA1c | Standard Deviation 0.58 |
| Pioglitazone 45 mg | Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 7.2 percentage of HbA1c | Standard Deviation 0.9 |
Secondary
Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.
Time frame: Baseline to Week 26 post-dose
Population: Apolipoprotein A-I was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 145.3 mg/dL | Standard Deviation 25.11 |
| Placebo | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 146.2 mg/dL | Standard Deviation 26.39 |
| Rivoglitazone 1.0 mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 146.4 mg/dL | Standard Deviation 29.52 |
| Rivoglitazone 1.0 mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 145.7 mg/dL | Standard Deviation 27.6 |
| Rivoglitazone 1.5mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 145.2 mg/dL | Standard Deviation 24.31 |
| Rivoglitazone 1.5mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 145.9 mg/dL | Standard Deviation 27.37 |
| Pioglitazone 45 mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 143.6 mg/dL | Standard Deviation 22.88 |
| Pioglitazone 45 mg | Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 143.9 mg/dL | Standard Deviation 24.97 |
Secondary
Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are \<100 mg/dL.
Time frame: Baseline to Week 26 post-dose
Population: Apolipoprotein B was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 112.8 mg/dL | Standard Deviation 25.24 |
| Placebo | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 115.3 mg/dL | Standard Deviation 26.5 |
| Rivoglitazone 1.0 mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 113.6 mg/dL | Standard Deviation 28.6 |
| Rivoglitazone 1.0 mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 116.1 mg/dL | Standard Deviation 26.49 |
| Rivoglitazone 1.5mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 114.6 mg/dL | Standard Deviation 26.88 |
| Rivoglitazone 1.5mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 111.5 mg/dL | Standard Deviation 30.29 |
| Pioglitazone 45 mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 114.3 mg/dL | Standard Deviation 27.33 |
| Pioglitazone 45 mg | Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 110.3 mg/dL | Standard Deviation 28.9 |
Secondary
Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Time frame: Baseline up to 26 weeks post-dose
Population: Change in fasting plasma glucose levels were assessed in participants with values at both baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 6.1 mg/dL | Standard Deviation 39.61 |
| Rivoglitazone 1.0 mg | Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -22.1 mg/dL | Standard Deviation 34.75 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -32.4 mg/dL | Standard Deviation 38.48 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -29.5 mg/dL | Standard Deviation 40.32 |
Secondary
Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Time frame: Baseline up to 52 weeks post-dose
Population: Fasting plasma glucose (FPG) was assessed in participants with values at baseline and the extension visit at the end of Cycle 1. Participants who did not have both baseline and Week 52 data were not included in this analysis (n=1 each for Rivoglitazone 1.0 mg and Pioglitazone 45 mg groups).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -33.8 mg/dL | Standard Deviation 41.48 |
| Rivoglitazone 1.0 mg | Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -34.2 mg/dL | Standard Deviation 24.86 |
| Rivoglitazone 1.5mg | Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -29.5 mg/dL | Standard Deviation 31.39 |
| Pioglitazone 45 mg | Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -35.9 mg/dL | Standard Deviation 20.75 |
Secondary
Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Time frame: Baseline up to 52 weeks post-dose
Population: Hemoglobin A1c was assessed in participants with values at baseline and the extension visit at the end of Cycle 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.5 percent change in HbA1c | Standard Deviation 0.69 |
| Rivoglitazone 1.0 mg | Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.7 percent change in HbA1c | Standard Deviation 0.57 |
| Rivoglitazone 1.5mg | Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.7 percent change in HbA1c | Standard Deviation 0.67 |
| Pioglitazone 45 mg | Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.4 percent change in HbA1c | Standard Deviation 0.7 |
Secondary
Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered borderline high, and HOMA-IR scores \>3.80 are considered high and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity.
Time frame: Baseline up to 26 weeks post-dose
Population: Change in Homeostasis Model Assessment Index was assessed in participants with values for baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.4 score on a scale | Standard Deviation 7.56 |
| Rivoglitazone 1.0 mg | Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.5 score on a scale | Standard Deviation 3.79 |
| Rivoglitazone 1.5mg | Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -2.3 score on a scale | Standard Deviation 5.15 |
| Pioglitazone 45 mg | Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -2.2 score on a scale | Standard Deviation 7.56 |
Secondary
Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.
Time frame: Week -2 up to Week 52 post-dose
Population: Drug-related TEAEs were assessed in the Safety Set which included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Participants with drug-related TEAEs | 15 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Weight increased | 0 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pitting edema | 0 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Gastritis | 1 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fluid retention | 0 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema | 0 Participants |
| Placebo | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema peripheral | 1 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Weight increased | 5 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema peripheral | 14 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema | 2 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pitting edema | 6 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fluid retention | 3 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Gastritis | 3 Participants |
| Rivoglitazone 1.0 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Participants with drug-related TEAEs | 50 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema peripheral | 46 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Participants with drug-related TEAEs | 144 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Gastritis | 2 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema | 5 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pitting edema | 10 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Weight increased | 23 Participants |
| Rivoglitazone 1.5mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fluid retention | 2 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema | 9 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Fluid retention | 1 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Weight increased | 12 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Gastritis | 7 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Participants with drug-related TEAEs | 134 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Pitting edema | 13 Participants |
| Pioglitazone 45 mg | Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Edema peripheral | 46 Participants |
Secondary
Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Time frame: Baseline up to week 26 post-dose
Population: Fasting plasma glucose levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 161.1 mg/dL | Standard Deviation 44.28 |
| Placebo | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 167.5 mg/dL | Standard Deviation 41.23 |
| Rivoglitazone 1.0 mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 136.5 mg/dL | Standard Deviation 39.73 |
| Rivoglitazone 1.0 mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 159.2 mg/dL | Standard Deviation 42.33 |
| Rivoglitazone 1.5mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 160.9 mg/dL | Standard Deviation 40.24 |
| Rivoglitazone 1.5mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 128.6 mg/dL | Standard Deviation 35.06 |
| Pioglitazone 45 mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 161.9 mg/dL | Standard Deviation 42.96 |
| Pioglitazone 45 mg | Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 132.3 mg/dL | Standard Deviation 38.32 |
Secondary
Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Time frame: Baseline up to Week 52 post-dose
Population: Fasting plasma glucose (FPG) levels were assessed in participants with available data in the Study Extension Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 147.4 mg/dL | Standard Deviation 32.31 |
| Placebo | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 117.8 mg/dL | Standard Deviation 27.93 |
| Rivoglitazone 1.0 mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 116.6 mg/dL | Standard Deviation 24.12 |
| Rivoglitazone 1.0 mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 152.8 mg/dL | Standard Deviation 32.32 |
| Rivoglitazone 1.5mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 149.0 mg/dL | Standard Deviation 36 |
| Rivoglitazone 1.5mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 115.6 mg/dL | Standard Deviation 19.04 |
| Pioglitazone 45 mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 142.5 mg/dL | Standard Deviation 27.81 |
| Pioglitazone 45 mg | Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 124.9 mg/dL | Standard Deviation 36.92 |
Secondary
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Time frame: Baseline up to Week 52 post-dose
Population: Hemoglobin A1c levels were assessed using the Study Extension Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.5 percentage of HbA1c | Standard Deviation 0.46 |
| Placebo | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 7.0 percentage of HbA1c | Standard Deviation 0.72 |
| Rivoglitazone 1.0 mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 6.9 percentage of HbA1c | Standard Deviation 0.6 |
| Rivoglitazone 1.0 mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.6 percentage of HbA1c | Standard Deviation 0.53 |
| Rivoglitazone 1.5mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.6 percentage of HbA1c | Standard Deviation 0.51 |
| Rivoglitazone 1.5mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 6.9 percentage of HbA1c | Standard Deviation 0.58 |
| Pioglitazone 45 mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 7.4 percentage of HbA1c | Standard Deviation 0.48 |
| Pioglitazone 45 mg | Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 52 | 7.0 percentage of HbA1c | Standard Deviation 0.75 |
Secondary
High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C), good cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are \>40 mg/dL.
Time frame: Baseline to Week 26 post-dose
Population: High-density lipoprotein cholesterol was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 45.3 mg/dL | Standard Deviation 11.73 |
| Placebo | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 45.6 mg/dL | Standard Deviation 11.46 |
| Rivoglitazone 1.0 mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 50.4 mg/dL | Standard Deviation 14.84 |
| Rivoglitazone 1.0 mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 46.0 mg/dL | Standard Deviation 12.49 |
| Rivoglitazone 1.5mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 45.8 mg/dL | Standard Deviation 11.46 |
| Rivoglitazone 1.5mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 52.0 mg/dL | Standard Deviation 14.72 |
| Pioglitazone 45 mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 44.7 mg/dL | Standard Deviation 10.25 |
| Pioglitazone 45 mg | High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 49.7 mg/dL | Standard Deviation 12.65 |
Secondary
Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered borderline high, and HOMA-IR scores \>3.80 are considered high and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome.
Time frame: Baseline up to week 26 post-dose
Population: Homeostasis Model Assessment Index was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 6.2 score on a scale | Standard Deviation 6.98 |
| Placebo | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 6.8 score on a scale | Standard Deviation 5.65 |
| Rivoglitazone 1.0 mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 4.0 score on a scale | Standard Deviation 3.78 |
| Rivoglitazone 1.0 mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 5.6 score on a scale | Standard Deviation 4.64 |
| Rivoglitazone 1.5mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 6.0 score on a scale | Standard Deviation 6.65 |
| Rivoglitazone 1.5mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 3.7 score on a scale | Standard Deviation 4.49 |
| Pioglitazone 45 mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 6.2 score on a scale | Standard Deviation 6.92 |
| Pioglitazone 45 mg | Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 4.1 score on a scale | Standard Deviation 4.75 |
Secondary
Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C), bad cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are \<100 mg/dL.
Time frame: Baseline up to Week 26 post-dose
Population: Low-density lipoprotein cholesterol levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 108.5 mg/dL | Standard Deviation 29.68 |
| Placebo | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 111.8 mg/dL | Standard Deviation 31.37 |
| Rivoglitazone 1.0 mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 118.0 mg/dL | Standard Deviation 34.19 |
| Rivoglitazone 1.0 mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 112.8 mg/dL | Standard Deviation 32.37 |
| Rivoglitazone 1.5mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 112.1 mg/dL | Standard Deviation 32.35 |
| Rivoglitazone 1.5mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 118.7 mg/dL | Standard Deviation 36.99 |
| Pioglitazone 45 mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 110.5 mg/dL | Standard Deviation 33.6 |
| Pioglitazone 45 mg | Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 115.0 mg/dL | Standard Deviation 36.03 |
Secondary
Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.
Time frame: Baseline up to 26 weeks post-dose
Population: Percent change in apolipoprotein A-I was assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 2.0 percent change | Standard Deviation 12.22 |
| Rivoglitazone 1.0 mg | Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 1.0 percent change | Standard Deviation 12.88 |
| Rivoglitazone 1.5mg | Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.9 percent change | Standard Deviation 13.18 |
| Pioglitazone 45 mg | Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 0.8 percent change | Standard Deviation 13.09 |
Secondary
Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.
Time frame: Baseline up to 26 weeks post-dose
Population: Apolipoprotein B was assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 3.0 percent change | Standard Deviation 14.83 |
| Rivoglitazone 1.0 mg | Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -0.4 percent change | Standard Deviation 19.46 |
| Rivoglitazone 1.5mg | Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.1 percent change | Standard Deviation 21.24 |
| Pioglitazone 45 mg | Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -2.5 percent change | Standard Deviation 18.17 |
Secondary
Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C), good cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Time frame: Baseline to 26 weeks post-dose
Population: Percent change in high-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 2.7 percent change | Standard Deviation 14.3 |
| Rivoglitazone 1.0 mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 10.3 percent change | Standard Deviation 18.15 |
| Rivoglitazone 1.5mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 14.8 percent change | Standard Deviation 22.65 |
| Pioglitazone 45 mg | Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 12.3 percent change | Standard Deviation 21.97 |
Secondary
Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C), bad cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Time frame: Baseline up to 26 weeks post-dose
Population: Percent change in low-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 3.4 percent change in LDL | Standard Deviation 18.56 |
| Rivoglitazone 1.0 mg | Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 9.3 percent change in LDL | Standard Deviation 32.91 |
| Rivoglitazone 1.5mg | Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 9.6 percent change in LDL | Standard Deviation 30.02 |
| Pioglitazone 45 mg | Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 7.3 percent change in LDL | Standard Deviation 32.25 |
Secondary
Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the bad cholesterol, high-density lipoprotein cholesterol (HDL-C) - the good cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.
Time frame: Baseline up to 26 weeks post-dose
Population: Percent change in total cholesterol levels were assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 1.9 percent change in total cholesterol | Standard Deviation 13.01 |
| Rivoglitazone 1.0 mg | Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 4.0 percent change in total cholesterol | Standard Deviation 17.81 |
| Rivoglitazone 1.5mg | Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 5.3 percent change in total cholesterol | Standard Deviation 17.49 |
| Pioglitazone 45 mg | Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | 3.6 percent change in total cholesterol | Standard Deviation 16.31 |
Secondary
Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.
Time frame: Baseline up to 26 weeks post-dose
Population: Percent change in total triglyceride levels were assessed in participants with values at baseline and study endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -1.8 percent change in total triglycerides | Standard Deviation 26.52 |
| Rivoglitazone 1.0 mg | Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -10.3 percent change in total triglycerides | Standard Deviation 32.84 |
| Rivoglitazone 1.5mg | Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -11.7 percent change in total triglycerides | Standard Deviation 34.35 |
| Pioglitazone 45 mg | Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | -9.6 percent change in total triglycerides | Standard Deviation 45.84 |
Secondary
Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the bad cholesterol, high-density lipoprotein cholesterol (HDL-C) - the good cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Time frame: Baseline up to week 26 post-dose
Population: Total cholesterol levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 190.1 mg/dL | Standard Deviation 36.23 |
| Placebo | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 191.9 mg/dL | Standard Deviation 39.6 |
| Rivoglitazone 1.0 mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 198.0 mg/dL | Standard Deviation 40.39 |
| Rivoglitazone 1.0 mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 193.4 mg/dL | Standard Deviation 38.27 |
| Rivoglitazone 1.5mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 191.6 mg/dL | Standard Deviation 38.8 |
| Rivoglitazone 1.5mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 199.1 mg/dL | Standard Deviation 43.14 |
| Pioglitazone 45 mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 189.8 mg/dL | Standard Deviation 39.42 |
| Pioglitazone 45 mg | Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 194.6 mg/dL | Standard Deviation 41.84 |
Secondary
Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.
Time frame: Baseline up to Week 26 post-dose
Population: Total triglyceride levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 185.6 mg/dL | Standard Deviation 111.25 |
| Placebo | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 170.5 mg/dL | Standard Deviation 99.17 |
| Rivoglitazone 1.0 mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 148.0 mg/dL | Standard Deviation 91.88 |
| Rivoglitazone 1.0 mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 173.3 mg/dL | Standard Deviation 104.9 |
| Rivoglitazone 1.5mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 169.5 mg/dL | Standard Deviation 101.27 |
| Rivoglitazone 1.5mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 141.0 mg/dL | Standard Deviation 84.12 |
| Pioglitazone 45 mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Baseline | 175.0 mg/dL | Standard Deviation 96.75 |
| Pioglitazone 45 mg | Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus | Week 26 | 152.1 mg/dL | Standard Deviation 112.72 |