Phase 3
Completed N=1,912
Study of Rivoglitazone in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00484198 ↗Enrolled (actual)
1,912
Serious AEs
3.3%
Results posted
Jul 2021
Primary outcomePrimary: 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 — 7.7; 7.7; 7.7; 7.7 percentage of HbA1c
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
7.7; 7.7; 7.7; 7.7; 8.0; 7.3 | — |
| 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 |
0.3; -0.3; -0.6; -0.5 | — |
| 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 |
161.1; 159.2; 160.9; 161.9; 167.5; 136.5 | — |
| 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 |
6.1; -22.1; -32.4; -29.5 | — |
| 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 |
6.2; 5.6; 6.0; 6.2; 6.8; 4.0 | — |
| 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 |
0.4; -1.5; -2.3; -2.2 | — |
| 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 |
190.1; 193.4; 191.6; 189.8; 191.9; 198.0 | — |
| 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 |
1.9; 4.0; 5.3; 3.6 | — |
| 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 |
185.6; 173.3; 169.5; 175.0; 170.5; 148.0 | — |
| 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 |
-1.8; -10.3; -11.7; -9.6 | — |
| 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 |
108.5; 112.8; 112.1; 110.5; 111.8; 118.0 | — |
| 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 |
3.4; 9.3; 9.6; 7.3 | — |
| 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 |
45.3; 46.0; 45.8; 44.7; 45.6; 50.4 | — |
| 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 |
2.7; 10.3; 14.8; 12.3 | — |
| 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 |
145.3; 145.7; 145.2; 143.6; 146.2; 146.4 | — |
| 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 |
2.0; 1.0; 0.9; 0.8 | — |
| 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 |
112.8; 116.1; 114.6; 114.3; 115.3; 113.6 | — |
| 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 |
3.0; -0.4; -1.1; -2.5 | — |
| 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 |
7.5; 7.6; 7.6; 7.4; 7.0; 6.9 | — |
| 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 |
-0.5; -0.7; -0.7; -0.4 | — |
| 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 |
147.4; 152.8; 149.0; 142.5; 117.8; 116.6 | — |
| 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 |
-33.8; -34.2; -29.5; -35.9 | — |
| 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 |
15; 50; 144; 134; 1; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00484198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.