Type 2 Diabetes MellitusPhase 3NCT00484198
Study of Rivoglitazone in Type 2 Diabetes Mellitus
A Phase 3 study testing Pioglitazone and Rivoglitazone in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 183 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone and Rivoglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,912 participants
- Where
- 183 sitesin 18 countries
- Study dates
- 23 Apr 2007to 12 Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
183 sites in 18 countries.
183 sites in 18 countries
United States70 sites
Study site
Anniston, Alabama
Study site
Beaver, Pennsylvania
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Birmingham, Alabama
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Boise, Idaho
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Buena Park, California
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Carrollton, Texas
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Charleston, South Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Cleveland, Ohio
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Cleveland, Tennessee
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Columbia, South Carolina
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Conroe, Texas
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Corpus Christi, Texas
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Dallas, Texas
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Delaware, Ohio
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Delray Beach, Florida
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Denver, Colorado
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El Paso, Texas
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Evansville, Indiana
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Garden Grove, California
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Garland, Texas
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Honolulu, Hawaii
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Hoover, Alabama
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Hot Springs, Arkansas
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Huntington Park, California
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Indianapolis, Indiana
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Irving, Texas
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Jacksonville, Florida
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Jonesboro, Arkansas
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Kingsport, Tennessee
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Little Rock, Arkansas
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Los Angeles, California
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Lyndhurst, Ohio
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Madisonville, Kentucky
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Marion, Ohio
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Merritt Island, Florida
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Miami, Florida
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Midland, Texas
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Milwaukee, Wisconsin
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Morehead City, North Carolina
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Muscle Shoals, Alabama
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New Orleans, Louisiana
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New Tazewell, Tennessee
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Oklahoma City, Oklahoma
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Olympia, Washington
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Paramount, California
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Pembroke Pines, Florida
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Philadelphia, Pennsylvania
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Portage, Michigan
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Portland, Oregon
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Richmond, Virginia
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Sacramento, California
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Salisbury, North Carolina
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San Antonio, Texas
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San Diego, California
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Slidell, Louisiana
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Southfield, Michigan
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Springfield, Massachusetts
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St Louis, Missouri
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Statesville, North Carolina
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Syracuse, New York
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Tampa, Florida
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Tulsa, Oklahoma
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Voorhees Township, New Jersey
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Walnut Creek, California
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West Covina, California
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West Hills, California
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Wichita, Kansas
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Winston-Salem, North Carolina
India21 sites
Study site
Ahmedabad, Gujarat
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Aligarh, Uttar Pradesh
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Bangalore, Karnataka
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Belagavi, Karnataka
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Coimbatore, Tamil Nadu
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Dhantoli, Nagpur
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Gandhinagar, Gujarat
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Hyderabad, Andhra Pradesh
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Indore, Madhya Pradesh
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Jaipur, Rajasthan
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Karnāl, Haryana
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Kochi, Kerala
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Mangalore, Karnataka
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Mumbai, Maharashtra
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Mylapore, Chennai
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Rāmdaspeth, Nagpur
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Sarwa C., Jaipur
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Shāstri Nagar, Ghaziabad
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Vasanth Nagar, Bangalore
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Vijayawada, Andhra Pradesh
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Visakhapatnam, Andhra Pradesh
Germany19 sites
Study site
Aschaffenburg
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Augsburg
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Bad Oeynhausen
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Berlin
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Bosenheim
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Dortmund
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Dresden
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Friedrichsthal
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Giessen
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Halle
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Hamburg
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Kippenheim
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Mainz
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Rehlingen
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Riesa
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Saarbrücken
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Saarlouis
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Siegen
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Wiesbaden
Hungary8 sites
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Balatonfüred
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Békéscsaba
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Budapest
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Debrecen
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Eger
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Gyula
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Kaposvár
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Szentes
Czechia7 sites
Study site
Horní Město
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Karlovy Vary
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Prague
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Ústí nad Labem
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Vysoký Les
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Zlín
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Znojmo
Mexico7 sites
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Aguascalientes
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Cuernavaca, Morelos
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Durango
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Mérida, Yucatán
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Metepec, Toluca
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Monterrey, Nuevo León
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Puebla City
Peru6 sites
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La Victoria, Lima region
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Lima
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Magdalena del Mar, Lima region
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Monterrico, Sucro Lima
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San Juan de Miraflores, Lima region
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San Martín de Porres, Lima region
Slovakia6 sites
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Bratislava
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Lučenec
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Moldava nad Bodvou
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Nové Mesto nad Váhom
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Považská Bystrica
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Žilina
United Kingdom6 sites
Study site
Addlestone, Surrey
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Chippenham
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Edmonton, London
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Sunbury-on-Thames, Middlesex
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Swindon, Wiltshire
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Wakefield, West Yorks
Romania5 sites
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Arad
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Brasov
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Bucharest
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Satu Mare
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Târgu Mureş
Serbia5 sites
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Belgrade
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Kragujevac
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Niš
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Subotica
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Zemun
Ukraine5 sites
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Dnipro
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Kharkiv
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Kiev
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Lviv
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Simferopol
Latvia4 sites
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Daugavpils
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Kuldīga
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Liepāja
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Riga
Argentina3 sites
Study site
Loma Verde, Buenos Aires
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San Vicente, Córdoba Province
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Zárate, Buenos Aires
Chile3 sites
Study site
Santiago, Providencia
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Santiago
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Temuco
Puerto Rico3 sites
Study site
Rio Piedras
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San Juan
Study site
Villa Fontana, Carolina, 00983
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone, Placebo, Rivoglitazone
- Keywords
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
45 mg over-encapsulated tablet administered orally, once daily
PlaceboDrug
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
RivoglitazoneDrug
1.0 mg tablet administered orally, once daily
RivoglitazoneDrug
1.5 mg tablet administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Rivoglitazone 1.0 mg Receives: Drug: Rivoglitazone |
| 3 | Experimental | Rivoglitazone 1.5 mg Receives: Drug: Rivoglitazone |
| 4 | Active comparator | Pioglitazone 45 mg Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline up to week 26 post-dose
Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.
Measured: Baseline up to 26 weeks post-dose
Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.
Measured: Baseline up to Week 26 post-dose
Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.
Measured: Baseline up to 26 weeks post-dose
Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL.
Measured: Baseline up to Week 26 post-dose
Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Measured: Baseline up to 26 weeks post-dose
High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL.
Measured: Baseline to Week 26 post-dose
Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Measured: Baseline to 26 weeks post-dose
Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.
Measured: Baseline to Week 26 post-dose
Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.
Measured: Baseline up to 26 weeks post-dose
Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL.
Measured: Baseline to Week 26 post-dose
Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.
Measured: Baseline up to 26 weeks post-dose
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Measured: Baseline up to Week 52 post-dose
Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Measured: Baseline up to 52 weeks post-dose
Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Measured: Baseline up to Week 52 post-dose
Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Measured: Baseline up to 52 weeks post-dose
Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.
Measured: Week -2 up to Week 52 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study start23 Apr 2007
- Primary completion12 Feb 2009
- Study completion12 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484198
- Sponsor's protocol ID
- CS0011-A-U301
- Other IDs
- 2006-005047-28
- Status last verified
- Jul 2021
- First submitted
- 7 Jun 2007
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00484198
- Acronym / sponsor ID
- CS0011-A-U301
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,912 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2007 (actual)
- Primary completion
- 12 Feb 2009 (actual)
- Study completion
- 12 Feb 2009 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: RivoglitazoneRivoglitazone 1.0 mg |
| 3 | Experimental | Drug: RivoglitazoneRivoglitazone 1.5 mg |
| 4 | Active comparator | Drug: PioglitazonePioglitazone 45 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: Actos45 mg over-encapsulated tablet administered orally, once daily | Drug | 4 |
| PlaceboRivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule | Drug | 1 |
| Rivoglitazone1.0 mg tablet administered orally, once daily | Drug | 2 |
| Rivoglitazone1.5 mg tablet administered orally, once daily | Drug | 3 |
Primary outcome
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
Time frame: Baseline up to week 26 post-dose
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time frame: Baseline up to 26 weeks post-dose
Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
21 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to week 26 post-dose
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
Time frame: Baseline up to 26 weeks post-dose
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
Time frame: Baseline up to Week 26 post-dose
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
Time frame: Baseline up to 26 weeks post-dose
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
Time frame: Baseline up to Week 26 post-dose
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
Time frame: Baseline up to 26 weeks post-dose
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
Time frame: Baseline to Week 26 post-dose
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
Time frame: Baseline to 26 weeks post-dose
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
Time frame: Baseline to Week 26 post-dose
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
Time frame: Baseline up to 26 weeks post-dose
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
Time frame: Baseline to Week 26 post-dose
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
Time frame: Baseline up to 26 weeks post-dose
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time frame: Baseline up to Week 52 post-dose
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
Time frame: Baseline up to 52 weeks post-dose
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
Time frame: Baseline up to Week 52 post-dose
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
Time frame: Baseline up to 52 weeks post-dose
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
Time frame: Week -2 up to Week 52 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
183 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone and Rivoglitazone in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 183 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 183 sites in United States, India, Germany, Hungary, Czechia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to week 26 post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.