Type 2 DiabetesPhase 2RAISENCT00575874
Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
A Phase 2 study testing Rivoglitazone HCl and pioglitazone HCl in people with Type 2 Diabetes, run by Daiichi Sankyo Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline 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 and pioglitazone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Jan 2009
- 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
- HbA1c >6.5% and <10.0%
- FPG >126 mg/dL (7 mmol/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
- Imparied hepatic function
- NYHA Class II-IV cardiac status or hospitalization for CHF or EF<40%
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes
The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Rivoglitazone HCl, pioglitazone HCl, placebo
- Keywords
- rivoglitazone HCl, pioglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPAR gamma), type 2 diabetes mellitus
- 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.
Rivoglitazone HClDrug
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HClDrug
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HClDrug
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
pioglitazone HClDrug
30 mg capsules once daily for 12 weeks
placeboDrug
matching tablets or capsule once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks Receives: Drug: Rivoglitazone HCl |
| 2 | Experimental | 1.0 mg rivoglitazone HCl tablets once daily for 12 weeks Receives: Drug: rivoglitazone HCl |
| 3 | Experimental | 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks Receives: Drug: rivoglitazone HCl |
| 4 | Active comparator | 30 mg pioglitazone HCl capsules once daily for 12 weeks Receives: Drug: pioglitazone HCl |
| 5 | Placebo comparator | Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules 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 HCl compared to that for placebo
Measured: 12 weeks
Secondary outcomes (1)
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl
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 startAug 2007
- Primary completionJun 2008
- Study completionJan 2009
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575874
- Sponsor's protocol ID
- CS011-A-J205
- Acronym
- RAISE
- Status last verified
- Feb 2009
- First submitted
- 14 Dec 2007
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00575874
- Acronym / sponsor ID
- RAISE / CS011-A-J205
- Conditions
- Type 2 Diabetes
- Keywords
- rivoglitazone HCl, pioglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPAR gamma), type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (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 the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline 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
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rivoglitazone HCl0.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
| 2 | Experimental | Drug: rivoglitazone HCl1.0 mg rivoglitazone HCl tablets once daily for 12 weeks |
| 3 | Experimental | Drug: rivoglitazone HCl1.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
| 4 | Active comparator | Drug: pioglitazone HCl30 mg pioglitazone HCl capsules once daily for 12 weeks |
| 5 | Placebo comparator | Drug: placeboMatching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules |
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
- HbA1c >6.5% and <10.0%
- FPG >126 mg/dL (7 mmol/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
- Imparied 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 rivoglitazone HCl tablets once daily for 12 weeks | Drug | 1 |
| rivoglitazone HCl1.0 mg rivoglitazone HCl tablets once daily for 12 weeks | Drug | 2 |
| rivoglitazone HCl1.5 mg rivoglitazone HCl tablets once daily for 12 weeks | Drug | 3 |
| pioglitazone HCl30 mg capsules once daily for 12 weeks | Drug | 4 |
| placebomatching tablets or capsule once daily for 12 weeks | Drug | 5 |
Primary outcome
Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo
Time frame: 12 weeks
1 secondary outcome
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl
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 9 Feb 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.
1 site 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 and pioglitazone HCl in people with Type 2 Diabetes, run by Daiichi Sankyo Co., Ltd. at 1 site in China.
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 9 Feb 2009. 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 China. 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 HCl compared to that for 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 9 Feb 2009.