Diabetes Mellitus Type 2Phase 1NCT00517465
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
A Phase 1 study testing RG1511 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 8 sites in 4 countries.
Trial summary
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo 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?
- RG1511
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2007to Mar 2009
- 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;
- type 2 diabetic patients;
- naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.
Who cannot join
- type 1 diabetes mellitus;
- clinically significant cardiovascular disease.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom2 sites
Study site
Slough, SL1 4AA
Study site
Welwyn Garden City, AL7 1TW
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, RG1511
- 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
RG1511Drug
Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RG1511 |
| 2 | Experimental | Not described Receives: Drug: RG1511 |
| 3 | Experimental | Not described Receives: Drug: RG1511 |
| 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.
AEs, laboratory parameters, vital signs.
Measured: Throughout study
Glucose AUC
Measured: Days -1, 1 and 8.
Secondary outcomes (4)
Insulin, C-peptide, glucagon and GLP-1 AUC
Measured: Days -1, 1 and 8
24h glucose
Measured: Days -1, 1 and 8
Lipid profiles
Measured: Days -1 and 8
Pharmacokinetic parameters
Measured: Days 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionMar 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 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
- NCT00517465
- Sponsor's protocol ID
- NP20945
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2007
- 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, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients
- ClinicalTrials.gov ID
- NCT00517465
- Acronym / sponsor ID
- NP20945
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Aug 2007 (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 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RG1511 |
| 2 | Experimental | Drug: RG1511 |
| 3 | Experimental | Drug: RG1511 |
| 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 (3 listed)
- adult patients, 18-65 years of age;
- type 2 diabetic patients;
- naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.
Key exclusion criteria (2 listed)
- type 1 diabetes mellitus;
- clinically significant cardiovascular disease.
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 | Drug | 4 |
| RG1511Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid. | Drug | 1, 2, 3 |
Primary outcome
AEs, laboratory parameters, vital signs.
Time frame: Throughout study
Glucose AUC
Time frame: Days -1, 1 and 8.
4 secondary outcomes
Insulin, C-peptide, glucagon and GLP-1 AUC
Time frame: Days -1, 1 and 8
24h glucose
Time frame: Days -1, 1 and 8
Lipid profiles
Time frame: Days -1 and 8
Pharmacokinetic parameters
Time frame: Days 1 and 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.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RG1511 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 8 sites in 4 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 2 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 8 sites in Germany, Hungary, Slovakia, United Kingdom. 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?
AEs, laboratory parameters, vital signs. (time frame: Throughout study). 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.