A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)
1 other identifier
interventional
289
9 countries
48
Brief Summary
This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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 Jul 2007
Shorter than P25 for phase_2 diabetes-mellitus-type-2
48 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
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedAugust 5, 2016
August 1, 2016
9 months
July 17, 2007
August 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in hemoglobin A1c (HbA1c)
Week 12
Secondary Outcomes (2)
Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
Week 12
Adverse events (AEs), vital signs, laboratory parameters.
Throughout study
Study Arms (5)
RO4876904 1
EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 2
EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 3
EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 4
EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Placebo
PLACEBO COMPARATORPlacebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- type 2 diabetes diagnosed \>= 1 month before screening;
- drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
- BMI 25-45kg/m2.
You may not qualify if:
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Concord, California, 94520, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Avon, Indiana, 46123, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Oxon Hill, Maryland, 20745, United States
Unknown Facility
Troy, Michigan, 48098, United States
Unknown Facility
Omaha, Nebraska, 68154, United States
Unknown Facility
Binghamton, New York, 13901, United States
Unknown Facility
Charlotte, North Carolina, 28211, United States
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Beaver, Pennsylvania, 15009, United States
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Adelaide, 5000, Australia
Unknown Facility
Canberra, 2605, Australia
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St Leonards, 2065, Australia
Unknown Facility
São Paulo, 01244-030, Brazil
Unknown Facility
São Paulo, 04022-001, Brazil
Unknown Facility
Guatemala City, 01015, Guatemala
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Hong Kong, Hong Kong
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31238, Mexico
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Guadalajara, 44650, Mexico
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Guadalajara, 45200, Mexico
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Mexico City, 11650, Mexico
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Pachuca, 42086, Mexico
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Tampico, 89109, Mexico
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Moscow, 109263, Russia
Unknown Facility
Moscow, 117036, Russia
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Moscow, 121069, Russia
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Moscow, 125315, Russia
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Moscow, 129110, Russia
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Saint Petersburg, 195112, Russia
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Saint Petersburg, 195213, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 197198, Russia
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Saratov, 410038, Russia
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Yaroslavl, 150010, Russia
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Yaroslavl, 150062, Russia
Unknown Facility
Alzira, 46600, Spain
Unknown Facility
Bacarot Alicant, 03114, Spain
Unknown Facility
Badalona, Spain
Unknown Facility
Barcelona, 08022, Spain
Unknown Facility
Ferrol, 15405, Spain
Unknown Facility
Bath, BA1 2SR, United Kingdom
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Frome, BA11 1EZ, United Kingdom
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Glasgow, G45 9AW, United Kingdom
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Liverpool, L9 7AL, United Kingdom
Unknown Facility
Motherwell, ML1 3JX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
July 17, 2007
First Posted
July 18, 2007
Study Start
July 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 5, 2016
Record last verified: 2016-08