Diabetes Mellitus Type 2Phase 2NCT01516476
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
A Phase 2 study testing RO6807952 and liraglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- RO6807952 and liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >/= 18 and </=70 years of age
- Diagnosis of diabetes mellitus, type 2 for at least 3 months
- Treated with a stable dose of metformin
- Hemoglobin A1c >/=7.0% and </=10.5% at screening
- Fasting plasma glucose </=240 mg/dL at screening
- Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
- Willing and able to maintain existing diet and exercise habits throughout the study
- C-peptide >1.5 ng/mL at screening
Who cannot join
- History of significant liver or kidney disease
- History of uncontrolled hypertension
- History of significant cardiovascular disease
- History of significant diabetic complications
- History of significant gastrointestinal conditions
- History of weight loss surgery or procedures involving the gastrointestinal tract
- History of chronic or acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RO6807952, liraglutide
- 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 for 12 weeks
RO6807952Drug
multiple doses for 12 weeks
RO6807952Drug
multiple doses for 12 weeks
liraglutideDrug
liraglutide for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide Arm | Experimental | Not described Receives: Drug: liraglutide |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| RO6807952 Arm 1 | Experimental | Not described Receives: Drug: RO6807952 |
| RO6807952 Arm 2 | Experimental | Not described Receives: Drug: RO6807952 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c (HA1c)
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change in fasting plasma glucose
Measured: Baseline and 12 weeks
Safety (incidence of adverse events)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
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
- 2 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
- NCT01516476
- Sponsor's protocol ID
- BP27804
- Status last verified
- Nov 2016
- First submitted
- 12 Jan 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone
- ClinicalTrials.gov ID
- NCT01516476
- Acronym / sponsor ID
- BP27804
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Jan 2012 (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 randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liraglutide Arm | Experimental | Drug: liraglutide |
| Placebo Arm | Placebo comparator | Drug: Placebo |
| RO6807952 Arm 1 | Experimental | Drug: RO6807952 |
| RO6807952 Arm 2 | Experimental | Drug: RO6807952 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients >/= 18 and </=70 years of age
- Diagnosis of diabetes mellitus, type 2 for at least 3 months
- Treated with a stable dose of metformin
- Hemoglobin A1c >/=7.0% and </=10.5% at screening
- Fasting plasma glucose </=240 mg/dL at screening
Key exclusion criteria (7 listed)
- History of significant liver or kidney disease
- History of uncontrolled hypertension
- History of significant cardiovascular disease
- History of significant diabetic complications
- History of significant gastrointestinal conditions
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 for 12 weeks | Drug | Placebo Arm |
| RO6807952multiple doses for 12 weeks | Drug | RO6807952 Arm 1 |
| RO6807952multiple doses for 12 weeks | Drug | RO6807952 Arm 2 |
| liraglutideliraglutide for 12 weeks | Drug | Liraglutide Arm |
Primary outcome
Change in hemoglobin A1c (HA1c)
Time frame: Baseline and 12 weeks
2 secondary outcomes
Change in fasting plasma glucose
Time frame: Baseline and 12 weeks
Safety (incidence of adverse events)
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO6807952 and liraglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 1 site in United States.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early. Results are not available in the source record.
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?
Change in hemoglobin A1c (HA1c) (time frame: Baseline and 12 weeks). 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 2 Nov 2016.