Clinical trial NCT00800176: A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Official title: A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes, diagnosed for \>=3 months;
* either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

* type 1 diabetes mellitus;
* currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
* currently or within 6 months prior to screening treated with any PPARgamma agonist;
* uncontrolled hypertension;
* significant pre-diagnosed diabetic complications requiring treatment.

Primary outcomes:
measure: Absolute Change in HbA1c
timeFrame: Baseline, Week 4, Week 8 and Week 12
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (mmol/L)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Daily Glucose Concentration (mmol/L)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fructosamine Concentration (μmol/L)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Body Weight (kg)
timeFrame: Baseline and Week 12
measure: Percentage of Participants Treated to Target HbA1c < 7%
timeFrame: Baseline up to 12 weeks
measure: Percentage of Participants Treated to Target HbA1c < 6.5%
timeFrame: Baseline up to 12 weeks
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: Baseline up to 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hayden Lake
country: United States
state: Idaho
city: Rochester
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Midland
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Adelaide
country: Australia
city: St. Leonards
country: Australia
city: Fortaleza
country: Brazil
city: Goiania
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Falkensee
country: Germany
city: Luebeck
country: Germany
city: Mainz
country: Germany
city: Neuss
country: Germany
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Fukuoka
country: Japan
city: Ibaraki
country: Japan
city: Kanagawa
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Saitama
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Jelgava
country: Latvia
city: Riga
country: Latvia
city: Talsi
country: Latvia
city: Valmiera
country: Latvia
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Alba-iulia
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Targu-mures
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: S.petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Alzira
country: Spain
city: Lerida
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: