Diabetes Mellitus Type 2Phase 1NCT00961909
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing RO5095932 and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 6 sites in United States.
Trial summary
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. 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 and metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2009to Oct 2010
- 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
- females who are either surgically sterile or post-menopausal
- type 2 diabetes treated with a stable dose of metformin
- BMI between 25-39kg/m2
- HbA1c between 7 and 10%
- fasting plasma glucose between 7 and 13.3mmol/L
Who cannot join
- history of clinically significant cardiovascular disease
- history of clinically significant hepatic or renal disease or impairment
- recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Anaheim, California, 92801
Study site
Chula Vista, California, 91911
Study site
Fort Myers, Florida, 33901
Study site
Miramar, Florida, 33025
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78229-4801
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- RO5095932, metformin, placebo
- 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.
RO5095932Drug
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
RO5095932Drug
dose titration to target dose, sc once weekly for 6 weeks
metforminDrug
stable dose
placeboDrug
sc once weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1active | Experimental | Not described Receives: Drug: RO5095932; Drug: metformin |
| 1placebo | Placebo comparator | Not described Receives: Drug: metformin; Drug: placebo |
| 2active | Experimental | Not described Receives: Drug: RO5095932; Drug: metformin |
| 2placebo | Placebo comparator | Not described Receives: Drug: metformin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Measured: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Change in hemoglobin A1c (HbA1c)
Measured: from baseline to week 6
Secondary outcomes (2)
Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
Measured: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
Change in metabolic parameters: glucose, insulin, C-peptide
Measured: assessed after 4 or 6 weeks on study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2010
- Study completionOct 2010
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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 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
- NCT00961909
- Sponsor's protocol ID
- NP22340
- Status last verified
- Nov 2016
- First submitted
- 18 Aug 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 Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
- ClinicalTrials.gov ID
- NCT00961909
- Acronym / sponsor ID
- NP22340
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Aug 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 assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1active | Experimental | Drug: RO5095932, Drug: metformin |
| 1placebo | Placebo comparator | Drug: metformin, Drug: placebo |
| 2active | Experimental | Drug: RO5095932, Drug: metformin |
| 2placebo | Placebo comparator | Drug: metformin, Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients, 18-65 years of age
- females who are either surgically sterile or post-menopausal
- type 2 diabetes treated with a stable dose of metformin
- BMI between 25-39kg/m2
- HbA1c between 7 and 10%
Key exclusion criteria (3 listed)
- history of clinically significant cardiovascular disease
- history of clinically significant hepatic or renal disease or impairment
- recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
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 |
|---|---|---|
| RO5095932cohorts receiving multiple ascending doses, sc once weekly for 4 weeks | Drug | 1active |
| RO5095932dose titration to target dose, sc once weekly for 6 weeks | Drug | 2active |
| metforminstable dose | Drug | 1active, 1placebo, 2active, 2placebo |
| placebosc once weekly for 4 weeks | Drug | 1placebo, 2placebo |
Primary outcome
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Time frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Change in hemoglobin A1c (HbA1c)
Time frame: from baseline to week 6
2 secondary outcomes
Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
Time frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
Change in metabolic parameters: glucose, insulin, C-peptide
Time frame: assessed after 4 or 6 weeks on study treatment
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
6 sites 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 and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 6 sites 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 6 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 6 sites 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: AEs, laboratory parameters, ECG, body weight, vital signs (time frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up). The study lists 2 primary outcomes in all. 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.