Diabetes Mellitus Type 2Phase 1NCT01044017
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
A Phase 1 study testing RO4998452 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. 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?
- RO4998452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Aug 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 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 mellitus, diagnosed for at least 3 months at screening
- Treatment with diet and exercise
- BMI between 27 and 40 kg/m2
Who cannot join
- Type 1 diabetes
- History of ketoacidosis, hyperosmolar coma, or lactic acidosis
- Renal disease or renal dysfunction
- Evidence of significant diabetic complication
- Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
- History of anti-diabetic triple therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RO4998452
- 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
single oral dose
RO4998452Drug
single oral doses
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: RO4998452 |
| B | Experimental | Not described Receives: Drug: RO4998452 |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on postprandial plasma glucose concentration
Measured: Following meal 13 hours after dosing
Secondary outcomes (4)
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
Measured: 25 hours
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Measured: Assessments up to 25 hours after dosing
Urinary glucose excretion
Measured: Assessments up to 25 hours after dosing
Safety and tolerability: AEs, laboratory parameters
Measured: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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
- NCT01044017
- Sponsor's protocol ID
- BP22764
- Other IDs
- 2009-013124-23, 2009
- Status last verified
- Nov 2016
- First submitted
- 17 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 Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01044017
- Acronym / sponsor ID
- BP22764
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Jan 2010 (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, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: RO4998452 |
| B | Experimental | Drug: RO4998452 |
| C | Placebo comparator | Drug: Placebo |
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 mellitus, diagnosed for at least 3 months at screening
- Treatment with diet and exercise
- BMI between 27 and 40 kg/m2
Key exclusion criteria (6 listed)
- Type 1 diabetes
- History of ketoacidosis, hyperosmolar coma, or lactic acidosis
- Renal disease or renal dysfunction
- Evidence of significant diabetic complication
- Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
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 |
|---|---|---|
| Placebosingle oral dose | Drug | C |
| RO4998452single oral doses | Drug | A, B |
Primary outcome
Effect on postprandial plasma glucose concentration
Time frame: Following meal 13 hours after dosing
4 secondary outcomes
Mean postprandial daily plasma glucose concentration (3 consecutive meals)
Time frame: 25 hours
Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration
Time frame: Assessments up to 25 hours after dosing
Urinary glucose excretion
Time frame: Assessments up to 25 hours after dosing
Safety and tolerability: AEs, laboratory parameters
Time frame: AEs throughout study, laboratory assessments on 3 treatment days and on follow-up
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 RO4998452 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 1 site in France.
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 6 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 France. 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?
Effect on postprandial plasma glucose concentration (time frame: Following meal 13 hours after dosing). 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.