Not provided
Not provided
Not provided
Not provided
Not provided
DSPD focusing on Study 301 to confirm the clinical profile before proceeding. Daiichi Sankyo Pharma Development terminated this study on 23 Apr 2008 because of changes in the clinical development plan with 94 of 2600 planned, randomized participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | rivoglitazone HCl 0.5mg |
|
| 2 | Experimental | rivoglitazone HCl 1.0 mg |
|
| 3 | Experimental | rivoglitazone HCl 1.5 mg |
|
| 4 | Placebo Comparator | placebo matching rivoglitazone HCl tablets |
|
| 5 | Active Comparator | pioglitazone HCl 15 mg |
|
| 6 | Active Comparator | pioglitazone HCl 30 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivoglitazone HCl | Drug | 0.5 mg tablets administered orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Rivoglitazone 0.5mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 | Active Comparator | pioglitazone HCl 45 mg |
|
| 8 | Placebo Comparator | matching placebo for pioglitazone |
|
| rivoglitazone HCl | Drug | 1.0 mg tablets administered orally, once daily |
|
|
| rivoglitazone HCl | Drug | 1.5 mg tablets administered orally, once daily |
|
|
| placebo | Drug | placebo tablets matching rivoglitazone tablets administered orally, once daily |
|
| pioglitazone HCl | Drug | 15 mg capsules administered orally, once daily |
|
| pioglitazone HCl | Drug | 30 mg capsules administered orally, once daily |
|
| pioglitazone HCl 45 mg | Drug | 45 mg capsules administered orally, once daily |
|
| placebo | Drug | placebo capsules for pioglitazone administered orally, once daily |
|
| metformin | Drug | Oral tablets. Rescue medication. |
|
| Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| 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. | Baseline up to week 12 post-dose. |
| Number of Participants 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. | Baseline up to week 26 post-dose, approximately a total of 27 weeks. |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| San Diego | California | 92128 | United States |
| San Francisco | California | 94115 | United States |
| Ridgefield | Connecticut | 06877 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Port Gibson | Mississippi | 39150 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Albuquerque | New Mexico | 87109 | United States |
| Kettering | Ohio | 45429 | United States |
| Fleetwood | Pennsylvania | 19522 | United States |
| Harrisburg | Pennsylvania | 17112 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Daingerfield | Texas | 75638 | United States |
| Dallas | Texas | 75216 | United States |
| Plano | Texas | 75093 | United States |
| San Antonio | Texas | 78205 | United States |
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
| FG002 | Rivoglitazone 1.0mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| FG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| FG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| FG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| FG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics were assessed from the All Randomized Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Rivoglitazone 0.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks. |
| BG002 | Rivoglitazone 1.0mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| BG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| BG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| BG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| BG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | 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. | Posted | Mean | Standard Deviation | percentage of A1c | Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose. |
|
|
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline up to week 12 post-dose. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | Treatment-emergent adverse events were assessed from the Safety Set. | Posted | Count of Participants | Participants | Baseline up to week 26 post-dose, approximately a total of 27 weeks. |
|
Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Rivoglitazone 0.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG002 | Rivoglitazone 1.0mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. | 0 | 27 | 0 | 27 | 8 | 27 |
| EG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. | 0 | 24 | 0 | 24 | 10 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Red blood cell morphology abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Week 2 |
|
|
| Change in Baseline to Week 2 |
|
|
| Week 4 |
|
|
| Change from Baseline to Week 4 |
|
|
| Week 6 |
|
|
| Change from Baseline to Week 6 |
|
|
| Week 8 |
|
|
| Change from Baseline to Week 8 |
|
|
| Week 10 |
|
|
| Change from Baseline to Week 10 |
|
|
| Week 12 |
|
|
| Change from Baseline to Week 12 |
|
|
| Week 16 |
|
|
| Change from Baseline to Week 16 |
|
|
| Week 20 |
|
|
| Change from Baseline to Week 20 |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| Rivoglitazone 1.0mg |
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks. |
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
| OG003 | Rivoglitazone 1.5mg | Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks. |
| OG004 | Pioglitazone 15 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks. |
| OG005 | Pioglitazone 30 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks. |
| OG006 | Pioglitazone 45 mg | Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|