Type 2 DiabetesPhase 2NCT00575471
Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes
A Phase 2 study testing Rivoglitazone HCl in people with Type 2 Diabetes, run by Daiichi Sankyo Co., Ltd. at 3 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Rivoglitazone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2007to Mar 2008
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- HbA1c >6.5% and <10%
- FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L)
Who cannot join
- history of type 1 diabetes
- history of ketoacidosis
- current insulin therapy
- C-peptide <0.5ng/mL
- impaired hepatic function
- CHF or history of CHF (NYHA stage I - IV)
- uncontrolled hypertension
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.
The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Rivoglitazone HCl, Placebo
- Keywords
- rivoglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPARgamma), diabetes mellitus, type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Carotid Intimal Medial Thickness 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivoglitazone HClDrug
0.5 mg tablets once daily for 12 weeks
rivoglitazone HClDrug
1.0 mg tablets once daily for 12 weeks
rivoglitazone HClDrug
1.5 mg tablets once daily for 12 weeks
PlaceboDrug
Matching placebo tablets once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks Receives: Drug: Rivoglitazone HCl |
| 2 | Experimental | rivoglitazone HCl 1 mg tablets once daily for 12 weeks Receives: Drug: rivoglitazone HCl |
| 3 | Experimental | rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks Receives: Drug: rivoglitazone HCl |
| 4 | Placebo comparator | Matching placebo tablets once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline for rivoglitazone compared to placebo
Measured: 12 weeks
Secondary outcomes (1)
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575471
- Sponsor's protocol ID
- CS011-A-J204
- Status last verified
- Feb 2009
- First submitted
- 17 Dec 2007
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00575471
- Acronym / sponsor ID
- CS011-A-J204
- Conditions
- Type 2 Diabetes
- Keywords
- rivoglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPARgamma), diabetes mellitus, type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Dec 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.
The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rivoglitazone HClrivoglitazone HCl 0.5 mg tablets once daily for 12 weeks |
| 2 | Experimental | Drug: rivoglitazone HClrivoglitazone HCl 1 mg tablets once daily for 12 weeks |
| 3 | Experimental | Drug: rivoglitazone HClrivoglitazone HCl 1.5 mg tablets once daily for 12 weeks |
| 4 | Placebo comparator | Drug: PlaceboMatching placebo tablets once daily for 12 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- HbA1c >6.5% and <10%
- FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L)
Key exclusion criteria (7 listed)
- history of type 1 diabetes
- history of ketoacidosis
- current insulin therapy
- C-peptide <0.5ng/mL
- impaired hepatic 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 |
|---|---|---|
| Rivoglitazone HCl0.5 mg tablets once daily for 12 weeks | Drug | 1 |
| rivoglitazone HCl1.0 mg tablets once daily for 12 weeks | Drug | 2 |
| rivoglitazone HCl1.5 mg tablets once daily for 12 weeks | Drug | 3 |
| PlaceboMatching placebo tablets once daily for 12 weeks | Drug | 4 |
Primary outcome
Change in HbA1c from baseline for rivoglitazone compared to placebo
Time frame: 12 weeks
1 secondary outcome
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo
Time frame: 12 weeks
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 Mar 2009.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rivoglitazone HCl in people with Type 2 Diabetes, run by Daiichi Sankyo Co., Ltd. at 3 sites in Japan.
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 7 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 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 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.
What does the primary outcome measure?
Change in HbA1c from baseline for rivoglitazone compared to placebo (time frame: 12 weeks). 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 Mar 2009.