Clinical trial NCT00484198: Study of Rivoglitazone in Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 1912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: Baseline up to week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
Secondary outcomes:
measure: 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
timeFrame: Baseline up to week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline up to week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline up to week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline up to Week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline up to Week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline to Week 26 post-dose
measure: 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
timeFrame: Baseline to 26 weeks post-dose
measure: 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
timeFrame: Baseline to Week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: 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
timeFrame: Baseline to Week 26 post-dose
measure: 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
timeFrame: Baseline up to 26 weeks post-dose
measure: Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
timeFrame: Baseline up to Week 52 post-dose
measure: 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
timeFrame: Baseline up to 52 weeks post-dose
measure: 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
timeFrame: Baseline up to Week 52 post-dose
measure: 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
timeFrame: Baseline up to 52 weeks post-dose
measure: 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
timeFrame: Week -2 up to Week 52 post-dose
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Buena Park
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Paramount
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: West Covina
country: United States
state: California
city: West Hills
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Delray Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Madisonville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Portage
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Voorhees
country: United States
state: New Jersey
city: Syracuse
country: United States
state: New York
city: Morehead City
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Delaware
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Marion
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state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Cleveland
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state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Carrollton
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state: Texas
city: Conroe
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
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state: Texas
city: El Paso
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Irving
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state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Loma Verde
country: Argentina
state: Buenos Aires
city: Zarate
country: Argentina
state: Buenos Aires
city: San Vicente
country: Argentina
state: Cordoba
city: Feldkirch
country: Austria
city: Graz
country: Austria
city: Wien
country: Austria
city: Santiago
country: Chile
state: Providencia
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Horní Město
country: Czechia
city: Karlovy Vary
country: Czechia
city: Prague
country: Czechia
city: Praha
country: Czechia
city: Usti nad Labem
country: Czechia
city: Vysoký Les
country: Czechia
city: Zlin
country: Czechia
city: Znojmo
country: Czechia
city: Aschaffenburg
country: Germany
city: Augsburg
country: Germany
city: Bad Oeynhausen
country: Germany
city: Berlin
country: Germany
city: Bosenheim
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Friedrichsthal
country: Germany
city: Giessen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Kippenheim
country: Germany
city: Mainz
country: Germany
city: Rehlingen
country: Germany
city: Riesa
country: Germany
city: Saarbrucken
country: Germany
city: Saarlouis
country: Germany
city: Siegen
country: Germany
city: Wiesbaden
country: Germany
city: Balatonfured
country: Hungary
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Szentes
country: Hungary
city: Hyderabad
country: India
state: Andhra Pradesh
city: Vijayawada
country: India
state: Andhra Pradesh
city: Visakhapatnam
country: India
state: Andhra Pradesh
city: Vasanth Nagar
country: India
state: Bangalore
city: Mylapore
country: India
state: Chennai
city: Shastri Nagar
country: India
state: Ghaziabad
city: Ahmedabad
country: India
state: Gujarat
city: Gandhinagar
country: India
state: Gujarat
city: Karnal
country: India
state: Haryana
city: Sarwa C.
country: India
state: Jaipur
city: Bangalore
country: India
state: Karnataka
city: Belgaum
country: India
state: Karnataka
city: Mangalore
country: India
state: Karnataka
city: Kochi
country: India
state: Kerala
city: Indore
country: India
state: Madhya Pradesh
city: Mumbai
country: India
state: Maharashtra
city: Dhantoli
country: India
state: Nagpur
city: Ramdaspeth
country: India
state: Nagpur
city: Jaipur
country: India
state: Rajasthan
city: Coimbatore
country: India
state: Tamil Nadu
city: Aligarh
country: India
state: Uttar Pradesh
city: Daugavpils
country: Latvia
city: Kuldiga
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Cuernavaca
country: Mexico
state: Morelos
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Metepec
country: Mexico
state: Toluca
city: Merida
country: Mexico
state: Yucatan
city: Aguascalientes
country: Mexico
city: Durango
country: Mexico
city: Puebla
country: Mexico
city: La Victoria
country: Peru
state: Lima
city: Magdalena del Mar
country: Peru
state: Lima
city: San Juan de Miraflores
country: Peru
state: Lima
city: San Martin de Porres
country: Peru
state: Lima
city: Monterrico
country: Peru
state: Sucro Lima
city: Lima
country: Peru
city: Rio Piedras
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Villa Fontana
country: Puerto Rico
city: Arad
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Satu Mare
country: Romania
city: Targu Mures
country: Romania
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Subotica
country: Serbia
city: Zemun
country: Serbia
city: Bratislava
country: Slovakia
city: Lucenec
country: Slovakia
city: Moldava nad Bodvou
country: Slovakia
city: Nove Mesto nad Vahom
country: Slovakia
city: Považská Bystrica
country: Slovakia
city: Zilina
country: Slovakia
city: Johannesburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Dnipropetrovs'k
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Simferopol
country: Ukraine
city: Edmonton
country: United Kingdom
state: London
city: Sunbury
country: United Kingdom
state: Middlesex
city: Addlestone
country: United Kingdom
state: Surrey
city: Wakefield
country: United Kingdom
state: West Yorks
city: Swindon
country: United Kingdom
state: Wiltshire
city: Chippenham
country: United Kingdom
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: