DiabetesPhase 2NCT00057317
Study 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 117 sites in 11 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 5 to 20 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
- How many people
- Not given
- Where
- 117 sitesin 11 countries
- Study dates
- Dec 2001to Dec 2003
- 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
117 sites in 11 countries.
117 sites in 11 countries
United States65 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Atlanta, Georgia, 30322
Study site
Billings, Montana, 59101
Study site
Boston, Massachusetts, 02215
Study site
Buffalo, New York, 14209
Study site
Camp Hill, Pennsylvania, 17011
Study site
Charlotte, North Carolina, 28209
Study site
Connellsville, Pennsylvania, 15425
Study site
Dallas, Texas, 75230
Study site
Durham, North Carolina, 27710
Study site
East Providence, Rhode Island, 02914
Study site
Edmonds, Washington, 98026
Study site
El Paso, Texas, 79902
Study site
Encino, California, 91436
Study site
Fountain Valley, California, 92708
Study site
Fremont, California, 94538
Study site
Fresno, California, 93720
Study site
Greenville, North Carolina, 27858-4354
Study site
Greer, South Carolina, 29651
Study site
Hamden, Connecticut, 06518
Study site
Hollywood, Florida, 33021
Study site
Honolulu, Hawaii, 96813
Study site
Houston, Texas, 77030
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46214-2985
Study site
Irvine, California, 92618
Study site
Jacksonville, Florida, 32204
Study site
Kansas City, Missouri, 64111
Study site
Las Vegas, Nevada, 89102
Study site
Lawrenceville, Georgia, 30045
Study site
Lebanon, Virginia, 24266
Study site
Memphis, Tennessee, 38119
Study site
Mesa, Arizona, 85206
Study site
Midland, Texas, 79705
Study site
Modesto, California, 95355
Study site
Morrisville, North Carolina, 27560
Study site
New Hyde Park, New York, 11040
Study site
New Orleans, Louisiana, 70121
Study site
Newark, Delaware, 19713
Study site
Norwalk, Connecticut, 06850
Study site
Ocala, Florida, 34471
Study site
Omaha, Nebraska, 68198-3032
Study site
Overland Park, Kansas, 66211
Study site
Pasadena, California, 91106
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Portland, Oregon, 97201
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14609
Study site
San Antonio, Texas, 78229-4801
Study site
San Antonio, Texas, 78229
Study site
San Antonio, Texas, 78284
Study site
San Bruno, California, 94066
Study site
Santa Rosa, California, 95405
Study site
Scottsdale, Arizona, 85251
Study site
St Louis, Missouri, 63104
Study site
St Louis, Missouri, 63110
Study site
Sunnyvale, California, 94086
Study site
Trenton, New Jersey, 08611
Study site
Tualatin, Oregon, 97062
Study site
Tucson, Arizona, 85710
Study site
Tucson, Arizona, 85723
Study site
Virginia Beach, Virginia, 23451
Study site
Wenatchee, Washington, 98801
Study site
West Palm Beach, Florida, 33401
Canada12 sites
Study site
Calgary, Alberta, T3B 0M3
Study site
Courtice, Ontario, L1E 3C3
Study site
Halifax, Nova Scotia, B3H 1V7
Study site
Laval, Quebec, H7T 2P5
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H3T 1E2
Study site
Ottawa, Ontario, K1Y 4E9
Study site
Sainte-Foy, Quebec, G1V 4G2
Study site
Sherbrooke, Quebec, J1G 5K2
Study site
St. John's, A1B 3V6
Study site
Windsor, Ontario, N8X 1K4
Study site
Winnipeg, Manitoba, R3E 3P4
Mexico11 sites
Study site
Guadalajara, 44280
Study site
Guadalajara, 44349
Study site
Mérida, 97000
Study site
Mexico City, 03100
Study site
Mexico City, 06700
Study site
Mexico City, 14050
Study site
Monterrey, 64320
Study site
Monterrey, 64410
Study site
Monterrey, 64460
Study site
Pachuca, Hidalgo, 42039
Study site
Tijuana, 22320
Romania8 sites
Study site
Arad, 2900
Study site
Brasov, 500326
Study site
Bucharest, 020475
Study site
Bucharest, 7000
Study site
Galati, 6200
Study site
Ploieşti, 2000
Study site
Targoviste, 0200
Study site
Târgu Mureş, 4300
Bulgaria4 sites
Study site
Pleven, 5800
Study site
Plovdiv, 4002
Study site
Sofia, 1233
Study site
Sofia, 1431
Estonia4 sites
Study site
Tallinn, 10138
Study site
Tartu, 50406
Study site
Tartu, 50708
Study site
Võru, 65609
Latvia4 sites
Study site
Ogre, 5001
Study site
Talsi, 3201
Study site
Tukums, 3100
Study site
Valmiera, LV-4201
Lithuania4 sites
Study site
Kaunas, 3036
Study site
Kaunas, 3040
Study site
Kaunas, 3042
Study site
Vilnius
United Kingdom3 sites
Study site
Bracknell, RG12 1HX
Study site
Nottingham, NG2 3HF
Study site
Plymouth, PL6 8BX
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and 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 5 to 20 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
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 startDec 2001
- Primary completionDec 2003
- Study completionDec 2003
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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057317
- Sponsor's protocol ID
- WM16177
- Status last verified
- Aug 2016
- First submitted
- 31 Mar 2003
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00057317
- Acronym / sponsor ID
- WM16177
- Conditions
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (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 5 to 20 mg/day will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
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 205-2349 | Drug | – |
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 24 Aug 2016.
Related trials for Diabetes
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
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
117 sites in 11 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 117 sites in 11 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 117 sites in United States, Canada, Mexico, Romania, Bulgaria and 6 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 24 Aug 2016.