Study of Rivoglitazone in Type 2 Diabetes Mellitus
A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
2 other identifiers
interventional
1,912
18 countries
183
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Apr 2007
Typical duration for phase_3 type-2-diabetes-mellitus
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2009
CompletedResults Posted
Study results publicly available
July 27, 2021
CompletedJuly 27, 2021
July 1, 2021
1.8 years
June 7, 2007
June 1, 2021
July 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline up to week 26 post-dose
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.
Baseline up to 26 weeks post-dose
Secondary Outcomes (21)
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
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
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
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
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
- +16 more secondary outcomes
Study Arms (4)
1
PLACEBO COMPARATOR2
EXPERIMENTALRivoglitazone 1.0 mg
3
EXPERIMENTALRivoglitazone 1.5 mg
4
ACTIVE COMPARATORPioglitazone 45 mg
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (183)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Hoover, Alabama, United States
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Muscle Shoals, Alabama, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Buena Park, California, United States
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Garden Grove, California, United States
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Huntington Park, California, United States
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Los Angeles, California, United States
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Paramount, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Walnut Creek, California, United States
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West Covina, California, United States
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West Hills, California, United States
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Denver, Colorado, United States
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Delray Beach, Florida, United States
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Jacksonville, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Madisonville, Kentucky, United States
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New Orleans, Louisiana, United States
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Slidell, Louisiana, United States
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Springfield, Massachusetts, United States
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Portage, Michigan, United States
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Southfield, Michigan, United States
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St Louis, Missouri, United States
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Voorhees Township, New Jersey, United States
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Syracuse, New York, United States
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Morehead City, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Delaware, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Cleveland, Tennessee, United States
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Kingsport, Tennessee, United States
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New Tazewell, Tennessee, United States
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Carrollton, Texas, United States
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Conroe, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Garland, Texas, United States
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Irving, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Milwaukee, Wisconsin, United States
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Loma Verde, Buenos Aires, Argentina
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Zárate, Buenos Aires, Argentina
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San Vicente, Córdoba Province, Argentina
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Feldkirch, Austria
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Graz, Austria
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Vienna, Austria
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Santiago, Providencia, Chile
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Santiago, Chile
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Temuco, Chile
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Horní Město, Czechia
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Karlovy Vary, Czechia
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Prague, Czechia
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Ústí nad Labem, Czechia
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Vysoký Les, Czechia
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Zlín, Czechia
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Znojmo, Czechia
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Aschaffenburg, Germany
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Augsburg, Germany
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Bad Oeynhausen, Germany
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Berlin, Germany
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Bosenheim, Germany
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Dortmund, Germany
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Dresden, Germany
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Friedrichsthal, Germany
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Giessen, Germany
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Halle, Germany
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Hamburg, Germany
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Kippenheim, Germany
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Mainz, Germany
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Rehlingen, Germany
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Riesa, Germany
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Saarbrücken, Germany
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Saarlouis, Germany
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Siegen, Germany
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Wiesbaden, Germany
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Balatonfüred, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gyula, Hungary
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Kaposvár, Hungary
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Szentes, Hungary
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Hyderabad, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Vasanth Nagar, Bangalore, India
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Mylapore, Chennai, India
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Shāstri Nagar, Ghaziabad, India
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Ahmedabad, Gujarat, India
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Gandhinagar, Gujarat, India
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Karnāl, Haryana, India
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Sarwa C., Jaipur, India
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Bangalore, Karnataka, India
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Belagavi, Karnataka, India
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Mangalore, Karnataka, India
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Kochi, Kerala, India
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Indore, Madhya Pradesh, India
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Mumbai, Maharashtra, India
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Dhantoli, Nagpur, India
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Rāmdaspeth, Nagpur, India
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Jaipur, Rajasthan, India
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Coimbatore, Tamil Nadu, India
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Aligarh, Uttar Pradesh, India
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Daugavpils, Latvia
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Kuldīga, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Metepec, Toluca, Mexico
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Mérida, Yucatán, Mexico
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Aguascalientes, Mexico
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Durango, Mexico
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Puebla City, Mexico
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La Victoria, Lima region, Peru
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Magdalena del Mar, Lima region, Peru
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San Juan de Miraflores, Lima region, Peru
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San Martín de Porres, Lima region, Peru
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Monterrico, Sucro Lima, Peru
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Lima, Peru
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Villa Fontana, Carolina, 00983, Puerto Rico
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Rio Piedras, Puerto Rico
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San Juan, Puerto Rico
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Arad, Romania
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Brasov, Romania
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Bucharest, Romania
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Satu Mare, Romania
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Târgu Mureş, Romania
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Belgrade, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Subotica, Serbia
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Zemun, Serbia
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Bratislava, Slovakia
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Lučenec, Slovakia
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Moldava nad Bodvou, Slovakia
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Nové Mesto nad Váhom, Slovakia
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Považská Bystrica, Slovakia
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Žilina, Slovakia
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Dnipro, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Simferopol, Ukraine
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Edmonton, London, United Kingdom
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Sunbury-on-Thames, Middlesex, United Kingdom
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Addlestone, Surrey, United Kingdom
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Wakefield, West Yorks, United Kingdom
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Swindon, Wiltshire, United Kingdom
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Chippenham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2007
First Posted
June 8, 2007
Study Start
April 23, 2007
Primary Completion
February 12, 2009
Study Completion
February 12, 2009
Last Updated
July 27, 2021
Results First Posted
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share