Diabetes Mellitus Type 2Phase 1NCT01017302
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
A Phase 1 study testing RO5095932 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 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- RO5095932
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, 18-65 years of age
- Diabetes mellitus, type 2 for at least 6 months before screening
- On treatment with stable doses of metformin for at least 3 months before screening
- BMI between >/=25 and </=39
Who cannot join
- Type 1 diabetes
- Pancreatitis
- Treatment with insulin for more than one week within 3 months prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RO5095932
- 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
Subcutenaous once weekly for 4 weeks
PlaceboDrug
Single subcutaneous dose in week 5
RO5095932Drug
Escalating subcutaneous doses once weekly over a 4 weeks period
RO5095932Drug
Single subcutenaous dose in week 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO5095932 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| 3 | Experimental | Not described Receives: Drug: RO5095932 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of various doses of RO5095932
Measured: Weeks 1-4, 6, 8
Secondary outcomes (3)
Safety and Tolerability of a single dose of RO5095932
Measured: Week 5, 6, 8
Pharmacokinetics: blood concentration
Measured: Weeks 1-4, 6, 8
Pharmacodynamics: glucose, insulin, C-peptide
Measured: Weeks 1-4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionAug 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01017302
- Sponsor's protocol ID
- NP22709
- Status last verified
- Nov 2016
- First submitted
- 19 Nov 2009
- 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 Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy
- ClinicalTrials.gov ID
- NCT01017302
- Acronym / sponsor ID
- NP22709
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Nov 2009 (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 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO5095932 |
| 2 | Placebo comparator | Drug: Placebo |
| 3 | Experimental | Drug: RO5095932 |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, 18-65 years of age
- Diabetes mellitus, type 2 for at least 6 months before screening
- On treatment with stable doses of metformin for at least 3 months before screening
- BMI between >/=25 and </=39
Key exclusion criteria (3 listed)
- Type 1 diabetes
- Pancreatitis
- Treatment with insulin for more than one week within 3 months prior to study start
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 |
|---|---|---|
| PlaceboSubcutenaous once weekly for 4 weeks | Drug | 2 |
| PlaceboSingle subcutaneous dose in week 5 | Drug | 4 |
| RO5095932Escalating subcutaneous doses once weekly over a 4 weeks period | Drug | 1 |
| RO5095932Single subcutenaous dose in week 5 | Drug | 3 |
Primary outcome
Safety and Tolerability of various doses of RO5095932
Time frame: Weeks 1-4, 6, 8
3 secondary outcomes
Safety and Tolerability of a single dose of RO5095932
Time frame: Week 5, 6, 8
Pharmacokinetics: blood concentration
Time frame: Weeks 1-4, 6, 8
Pharmacodynamics: glucose, insulin, C-peptide
Time frame: Weeks 1-4, 6, 8
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 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 1 study testing RO5095932 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 4 inclusion and 3 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Tolerability of various doses of RO5095932 (time frame: Weeks 1-4, 6, 8). 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.