DiabetesPhase 2NCT00057304
Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing RO 205-2349 in people with Diabetes, run by Hoffmann-La Roche at 46 sites in 9 countries.
Trial summary
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- RO 205-2349
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 46 sitesin 9 countries
- Study dates
- Jun 2003to Mar 2004
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 to 75
- Type 2 diabetes for longer than 3 months
- HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
- FPG (fasting plasma glucose) greater than 126 mg/dL at screening
- BMI (body mass index) less than 40 kg/square meter
Who cannot join
- Type I diabetes
- Type 2 diabetes patients currently treated with insulin
- Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
- FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
- Impaired liver or kidney function
- Triglycerides greater than 600 mg/dL
Show all 9Show fewer
- Uncontrolled hypertension
- Pregnant or lactating women
- Women not using adequate contraception
Trial locations and contacts
46 sites in 9 countries.
46 sites in 9 countries
United States14 sites
Study site
Camp Hill, Pennsylvania, 17011
Study site
Dallas, Texas, 75230
Study site
Durham, North Carolina, 27710
Study site
Greer, South Carolina, 29651
Study site
Hollywood, Florida, 33021
Study site
Houston, Texas, 77030
Study site
Lebanon, Virginia, 24266
Study site
Memphis, Tennessee, 38119
Study site
Memphis, Tennessee, 38163
Study site
Midland, Texas, 79705
Study site
Morrisville, North Carolina, 27560
Study site
Portland, Oregon, 97219
Study site
Portland, Oregon, 97239
Study site
Virginia Beach, Virginia, 23451
Mexico9 sites
Study site
Chihuahua, Chih.
Study site
Guadalajara, 44349
Study site
Guadalajara, JAL., 44340
Study site
Mérida, 97000
Study site
Mexico City, 06700
Study site
Monterrey, 64320
Study site
Monterrey, 64410
Study site
Monterrey, 64460
Study site
Pachuca, Hidalgo, 42039
Romania9 sites
Study site
Arad, 2900
Study site
Brasov, 500326
Study site
Bucharest, 020475
Study site
Bucharest, 7000
Study site
Craiova, 1100
Study site
Galati, 6200
Study site
Ploieşti, 2000
Study site
Targoviste, 0200
Study site
Târgu Mureş, 4300
Bulgaria5 sites
Study site
Pleven, 5800
Study site
Plovdiv, 4002
Study site
Sofia, 1233
Study site
Sofia, 1431
Study site
Sofia, 1606
Estonia4 sites
Study site
Tallinn, 10138
Study site
Tartu, 50406
Study site
Tartu, 50708
Study site
Võru, 65609
United Kingdom2 sites
Study site
Bracknell, RG12 1HX
Study site
Nottingham, NG2 3HF
About this study
Official title: A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
- Conditions
- Diabetes
- Being tested
- RO 205-2349
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO 205-2349Drug
Also called Edaglitazone
| Study group | Role | What they receive |
|---|---|---|
| RO 205-2349 2 mg QD | Experimental | RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. Receives: Drug: RO 205-2349 |
| RO 205-2349 5 mg QD | Experimental | RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. Receives: Drug: RO 205-2349 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2003 (estimated)
- Study startJun 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Model description
- All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period. treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057304
- Sponsor's protocol ID
- BM17151
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2003
- Last updated
- 28 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00057304
- Acronym / sponsor ID
- BM17151
- Conditions
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2003 (actual)
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 1 Apr 2003 (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.
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period. treatment
| Arm | Type | Receives |
|---|---|---|
| RO 205-2349 2 mg QD | Experimental | Drug: RO 205-2349RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. |
| RO 205-2349 5 mg QD | Experimental | Drug: RO 205-2349RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 35 to 75
- Type 2 diabetes for longer than 3 months
- HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
- FPG (fasting plasma glucose) greater than 126 mg/dL at screening
- BMI (body mass index) less than 40 kg/square meter
Key exclusion criteria (9 listed)
- Type I diabetes
- Type 2 diabetes patients currently treated with insulin
- Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
- FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
- Impaired liver or kidney function
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 |
|---|---|---|
| RO 205-2349Also: Edaglitazone | Drug | RO 205-2349 2 mg QD, RO 205-2349 5 mg QD |
Primary outcome
Not reported in the source record.
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 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO 205-2349 in people with Diabetes, run by Hoffmann-La Roche at 46 sites in 9 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 5 inclusion and 9 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Mexico, Romania, Bulgaria, Estonia and 4 more countries. 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. 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.
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 Apr 2023.