Diabetes Mellitus Type 2Phase 2NCT00823680
A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
A Phase 2 study testing RO5027838 and RO5093151 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 5 sites in 3 countries.
Trial summary
This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- RO5027838 and RO5093151
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2009to Aug 2009
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 35-65 years of age;
- type 2 diabetes for >=3 months;
- treated for >=3 months with stable dose of metformin >=1.5g/day or maximum tolerated dose.
Who cannot join
- history of diabetic ketoacidosis;
- currently or previously treated with insulin;
- currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
- treated with lipoprotein-modifying therapy within a month before screening.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Study site
Chula Vista, California, 91911
Study site
Miami, Florida, 330014
About this study
Official title: Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da
This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RO5027838, RO5093151
- 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
po bid for 4 weeks
RO5027838Drug
200mg po qd for 4 weeks
RO5027838Drug
50mg po bid for 4 weeks
RO5093151Drug
400mg po bid for 4 weeks
RO5093151Drug
10mg po bid for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RO5027838 200mg | Experimental | Not described Receives: Drug: RO5027838 |
| RO5027838 50mg | Experimental | Not described Receives: Drug: RO5027838 |
| RO5093151 10mg | Experimental | Not described Receives: Drug: RO5093151 |
| RO5093151 400mg | Experimental | Not described Receives: Drug: RO5093151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in mean daily plasma glucose
Measured: From baseline to day 27
Secondary outcomes (4)
Fasting plasma glucose
Measured: Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin
Measured: Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C
Measured: At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight
Measured: At baseline, and at planned visits up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
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
- 110 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
- NCT00823680
- Sponsor's protocol ID
- BP21850
- Other IDs
- 2008-001122-13, 2008
- Status last verified
- Jul 2016
- First submitted
- 15 Jan 2009
- Last updated
- 28 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da
- ClinicalTrials.gov ID
- NCT00823680
- Acronym / sponsor ID
- BP21850
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Jan 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 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| RO5027838 200mg | Experimental | Drug: RO5027838 |
| RO5027838 50mg | Experimental | Drug: RO5027838 |
| RO5093151 10mg | Experimental | Drug: RO5093151 |
| RO5093151 400mg | Experimental | Drug: RO5093151 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, 35-65 years of age;
- type 2 diabetes for >=3 months;
- treated for >=3 months with stable dose of metformin >=1.5g/day or maximum tolerated dose.
Key exclusion criteria (4 listed)
- history of diabetic ketoacidosis;
- currently or previously treated with insulin;
- currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
- treated with lipoprotein-modifying therapy within a month before screening.
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 |
|---|---|---|
| Placebopo bid for 4 weeks | Drug | Placebo |
| RO5027838200mg po qd for 4 weeks | Drug | RO5027838 200mg |
| RO502783850mg po bid for 4 weeks | Drug | RO5027838 50mg |
| RO5093151400mg po bid for 4 weeks | Drug | RO5093151 400mg |
| RO509315110mg po bid for 4 weeks | Drug | RO5093151 10mg |
Primary outcome
Absolute change in mean daily plasma glucose
Time frame: From baseline to day 27
4 secondary outcomes
Fasting plasma glucose
Time frame: Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin
Time frame: Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C
Time frame: At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight
Time frame: At baseline, and at planned visits up to week 4
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 28 Jul 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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5027838 and RO5093151 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 5 sites in 3 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 3 inclusion and 4 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Austria. 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 mean daily plasma glucose (time frame: From baseline to day 27). 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 28 Jul 2016.