A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
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
2 other identifiers
interventional
394
12 countries
67
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jan 2009
Shorter than P25 for phase_2 diabetes-mellitus-type-2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedStudy Start
First participant enrolled
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2009
CompletedResults Posted
Study results publicly available
November 18, 2020
CompletedNovember 18, 2020
November 1, 2020
9 months
December 1, 2008
September 9, 2020
November 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change in HbA1c
Baseline, Week 4, Week 8 and Week 12
Secondary Outcomes (10)
Change From Baseline in Fasting Plasma Glucose (mmol/L)
Baseline and Week 12
Change From Baseline in Mean Daily Glucose Concentration (mmol/L)
Baseline and Week 12
Change From Baseline in Fructosamine Concentration (μmol/L)
Baseline and 12 weeks
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)
Baseline and Week 12
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)
Baseline and Week 12
- +5 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
RO4998452 10mg
EXPERIMENTALDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
RO4998452 2.5mg
EXPERIMENTALDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
RO4998452 20mg
EXPERIMENTALDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
RO4998452 40mg
EXPERIMENTALDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
RO4998452 5mg
EXPERIMENTALDuring the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Unknown Facility
Phoenix, Arizona, 85015, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
Bradenton, Florida, 34208, United States
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Jacksonville, Florida, 32216, United States
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Atlanta, Georgia, 30342, United States
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Hayden Lake, Idaho, 83835, United States
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Rochester, New York, 14609, United States
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Greensboro, North Carolina, 27408, United States
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Midland, Texas, 79707, United States
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Richmond, Virginia, 23294, United States
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Adelaide, 5000, Australia
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St Leonards, 2065, Australia
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Fortaleza, 60120-021, Brazil
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Goiânia, 74043011, Brazil
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São Paulo, 01244-030, Brazil
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São Paulo, 04022-001, Brazil
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Vancouver, British Columbia, V5Z 1L8, Canada
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London, Ontario, NGA 4V2, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Berlin, 10115, Germany
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Falkensee, 14612, Germany
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Lübeck, 23562, Germany
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Mainz, 55116, Germany
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Neuss, 41460, Germany
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Fukuoka, 812-0025, Japan
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Ibaraki, 311-0113, Japan
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Kanagawa, 232-0064, Japan
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Osaka, 530-0001, Japan
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Saitama, 343-0827, Japan
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Saitama, 362-0021, Japan
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Tokyo, 160-0017, Japan
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Tokyo, 192-0071, Japan
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Jelgava, LV-3001, Latvia
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Riga, 1002, Latvia
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Talsi, 3200, Latvia
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Valmiera, 4201, Latvia
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Chihuahua City, 31238, Mexico
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Guadalajara, 44600, Mexico
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Guadalajara, 44650, Mexico
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Mexico City, 11650, Mexico
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Alba Iulia, 51077, Romania
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Brasov, 500365, Romania
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Bucharest, 020045, Romania
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Bucharest, 020475, Romania
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Bucharest, 020725, Romania
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Bucharest, Romania
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Târgu Mureş, 540004, Romania
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Moscow, 117049, Russia
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Moscow, 119121, Russia
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Moscow, 129110, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630047, Russia
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S.petersburg, 194017, Russia
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Saint Petersburg, 191124, Russia
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Saint Petersburg, 195257, Russia
Unknown Facility
Saint Petersburg, 197089, Russia
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Saint Petersburg, 197198, Russia
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Saratov, 410038, Russia
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Yaroslavl, 150062, Russia
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Alzira, 46600, Spain
Unknown Facility
Lleida, 25198, Spain
Unknown Facility
Seville, 41013, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
January 22, 2009
Primary Completion
October 28, 2009
Study Completion
October 28, 2009
Last Updated
November 18, 2020
Results First Posted
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).