Trial · NCT00484198
Study of Rivoglitazone in Type 2 Diabetes Mellitus
NCT00484198, Phase 3, Completed, Daiichi Sankyo; results first posted 2021-07-27
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ConductScience Library. Study of Rivoglitazone in Type 2 Diabetes Mellitus. Trials, record NCT00484198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00484198
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Rivoglitazone in Type 2 Diabetes Mellitus
- NCT number
- NCT00484198
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,912 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Pioglitazone, Placebo, Rivoglitazone, Rivoglitazone
- First posted
- 2007-06-08
- Last updated
- 2021-07-27
- Other registries' IDs
- eudract:2006-005047-28
- Results first posted
- 2021-07-27
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline up to week 26 post-dose | Percentage of hemoglobin A1c (HbA1c) levels are reported. |
| 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 | Baseline up to 26 weeks post-dose | Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline up to week 26 post-dose | Hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set. | percentage of HbA1c | MEAN |
| 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 | Baseline up to 26 weeks post-dose | Change in hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set. | percent change in HbA1c | MEAN |
| 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 | Baseline up to week 26 post-dose | Fasting plasma glucose levels were assessed in participants with available data in the Full Analysis Set. | mg/dL | MEAN |
| 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 | Baseline up to 26 weeks post-dose | Change in fasting plasma glucose levels were assessed in participants with values at both baseline and study endpoint. | mg/dL | MEAN |
| 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 | Baseline up to week 26 post-dose | Homeostasis Model Assessment Index was assessed in participants with available data in the Full Analysis Set. | score on a scale | MEAN |
| 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 | Baseline up to 26 weeks post-dose | Change in Homeostasis Model Assessment Index was assessed in participants with values for baseline and study endpoint. | score on a scale | MEAN |
| 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 | Baseline up to week 26 post-dose | Total cholesterol levels were assessed in participants with available data in the Full Analysis Set. | mg/dL | MEAN |
| 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 | Baseline up to 26 weeks post-dose | Percent change in total cholesterol levels were assessed in participants with values at baseline and study endpoint. | percent change in total cholesterol | MEAN |
| 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 | Baseline up to Week 26 post-dose | Total triglyceride levels were assessed in participants with available data in the Full Analysis Set. | mg/dL | MEAN |
| 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 | Baseline up to 26 weeks post-dose | Percent change in total triglyceride levels were assessed in participants with values at baseline and study endpoint. | percent change in total triglycerides | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Placebo | Baseline | 7.7 | Standard Deviation 0.55 | percentage of HbA1c |
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 | Rivoglitazone 1.0 mg | Baseline | 7.7 | Standard Deviation 0.54 | percentage of HbA1c |
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 | Rivoglitazone 1.5mg | Baseline | 7.7 | Standard Deviation 0.57 | percentage of HbA1c |
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 | Pioglitazone 45 mg | Baseline | 7.7 | Standard Deviation 0.58 | percentage of HbA1c |
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 | Placebo | Week 26 | 8.0 | Standard Deviation 0.86 | percentage of HbA1c |
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 | Rivoglitazone 1.0 mg | Week 26 | 7.3 | Standard Deviation 0.94 | percentage of HbA1c |
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 | Rivoglitazone 1.5mg | Week 26 | 7.1 | Standard Deviation 0.83 | percentage of HbA1c |
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 | Pioglitazone 45 mg | Week 26 | 7.2 | Standard Deviation 0.90 | percentage of HbA1c |
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 | Placebo | 0.3 | Standard Deviation 0.69 | percent change in HbA1c | |
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 | Rivoglitazone 1.0 mg | -0.3 | Standard Deviation 0.75 | percent change in HbA1c |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 137 | |
| Overall Study | STARTED | Rivoglitazone 1.0 mg | 274 | |
| Overall Study | STARTED | Rivoglitazone 1.5 mg | 750 | |
| Overall Study | STARTED | Pioglitazone 45 mg | 751 | |
| Overall Study | COMPLETED | Placebo | 96 | |
| Overall Study | COMPLETED | Rivoglitazone 1.0 mg | 208 | |
| Overall Study | COMPLETED | Rivoglitazone 1.5 mg | 599 | |
| Overall Study | COMPLETED | Pioglitazone 45 mg | 579 | |
| Overall Study | NOT COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Rivoglitazone 1.0 mg | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 137 | |
| other | Diarrhea | Gastrointestinal disorders | Rivoglitazone 1.0 mg | 1 | 269 | |
| other | Diarrhea | Gastrointestinal disorders | Rivoglitazone 1.5mg | 14 | 741 | |
| other | Diarrhea | Gastrointestinal disorders | Pioglitazone 45 mg | 17 | 739 | |
| other | Gastritis | Gastrointestinal disorders | Placebo | 3 | 137 | |
| other | Gastritis | Gastrointestinal disorders | Rivoglitazone 1.0 mg | 5 | 269 | |
| other | Gastritis | Gastrointestinal disorders | Rivoglitazone 1.5mg | 10 | 741 | |
| other | Gastritis | Gastrointestinal disorders | Pioglitazone 45 mg | 9 | 739 | |
| other | Edema peripheral | General disorders | Placebo | 3 | 137 | |
| other | Edema peripheral | General disorders | Rivoglitazone 1.0 mg | 18 | 269 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 137 |
| Total, all-cause mortality | Rivoglitazone 1.0 mg | 0 | 269 |
| Total, all-cause mortality | Rivoglitazone 1.5mg | 0 | 741 |
| Total, all-cause mortality | Pioglitazone 45 mg | 2 | 739 |
| Total, other adverse events | Placebo | 56 | 137 |
| Total, other adverse events | Rivoglitazone 1.0 mg | 131 | 269 |
| Total, other adverse events | Rivoglitazone 1.5mg | 408 | 741 |
| Total, other adverse events | Pioglitazone 45 mg | 374 | 739 |
| Total, serious adverse events | Placebo | 3 | 137 |
| Total, serious adverse events | Rivoglitazone 1.0 mg | 10 | 269 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00484198
GET https://conductscience.org/api/trials/v1/NCT00484198/registered?page=2