Diabetes Mellitus Type 2Phase 2NCT00502710
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
A Phase 2 study testing RO4876904 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 48 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- RO4876904
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 48 sitesin 9 countries
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
United States12 sites
Study site
Avon, Indiana, 46123
Study site
Beaver, Pennsylvania, 15009
Study site
Binghamton, New York, 13901
Study site
Charlotte, North Carolina, 28211
Study site
Chicago, Illinois, 60607
Study site
Concord, California, 94520
Study site
Hot Springs, Arkansas, 71913
Study site
Indianapolis, Indiana, 46260
Study site
Los Angeles, California, 90057
Study site
Omaha, Nebraska, 68154
Study site
Oxon Hill, Maryland, 20745
Study site
Troy, Michigan, 48098
Russia12 sites
Study site
Moscow, 109263
Study site
Moscow, 117036
Study site
Moscow, 121069
Study site
Moscow, 125315
Study site
Moscow, 129110
Study site
Saint Petersburg, 195112
Study site
Saint Petersburg, 195213
Study site
Saint Petersburg, 197089
Study site
Saint Petersburg, 197198
Study site
Saratov, 410038
Study site
Yaroslavl, 150010
Study site
Yaroslavl, 150062
Mexico7 sites
Study site
Aguascalientes, 20230
Study site
Chihuahua City, 31238
Study site
Guadalajara, 44650
Study site
Guadalajara, 45200
Study site
Mexico City, 11650
Study site
Pachuca, 42086
Study site
Tampico, 89109
Spain5 sites
Study site
Alzira, 46600
Study site
Bacarot Alicant, 03114
Study site
Badalona
Study site
Barcelona, 08022
Study site
Ferrol, 15405
United Kingdom5 sites
Study site
Bath, BA1 2SR
Study site
Frome, BA11 1EZ
Study site
Glasgow, G45 9AW
Study site
Liverpool, L9 7AL
Study site
Motherwell, ML1 3JX
Australia3 sites
Study site
Adelaide, 5000
Study site
Canberra, 2605
Study site
St Leonards, 2065
About this study
Official title: 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)
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RO4876904
- 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.
PlaceboDrug
Placebo po daily.
RO4876904Drug
Escalating doses, at a starting dose of 12.5mg po daily.
| Study group | Role | What they receive |
|---|---|---|
| RO4876904 1 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. Receives: Drug: RO4876904 |
| RO4876904 2 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. Receives: Drug: RO4876904 |
| RO4876904 3 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. Receives: Drug: RO4876904 |
| RO4876904 4 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. Receives: Drug: RO4876904 |
| Placebo | Placebo comparator | Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in hemoglobin A1c (HbA1c)
Measured: 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.
Measured: Week 12
Adverse events (AEs), vital signs, laboratory parameters.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502710
- Sponsor's protocol ID
- BC20779
- Status last verified
- Aug 2016
- First submitted
- 17 Jul 2007
- Last updated
- 5 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00502710
- Acronym / sponsor ID
- BC20779
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RO4876904 1 | Experimental | Drug: RO4876904Escalating 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 | Experimental | Drug: RO4876904Escalating 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 | Experimental | Drug: RO4876904Escalating 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 | Experimental | Drug: RO4876904Escalating 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 comparator | Drug: PlaceboPlacebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
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 |
|---|---|---|
| PlaceboPlacebo po daily. | Drug | Placebo |
| RO4876904Escalating doses, at a starting dose of 12.5mg po daily. | Drug | RO4876904 1, RO4876904 2, RO4876904 3, RO4876904 4 |
Primary outcome
Absolute change in hemoglobin A1c (HbA1c)
Time frame: Week 12
2 secondary outcomes
Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
Time frame: Week 12
Adverse events (AEs), vital signs, laboratory parameters.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO4876904 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 48 sites in 9 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 4 inclusion and 2 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Russia, Mexico, Spain, United Kingdom and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute change in hemoglobin A1c (HbA1c) (time frame: Week 12). 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 5 Aug 2016.