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Type 2 Diabetes MellitusPhase 3NCT00571519

Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

A Phase 3 study testing Rivoglitazone HCl, pioglitazone HCl and pioglitazone HCl 45 mg in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Rivoglitazone HCl, pioglitazone HCl and pioglitazone HCl 45 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
18 sitesUnited States
Study dates
14 Nov 2007to 23 May 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provided written informed consent at screening.
  • Diagnosed with type 2 diabetes mellitus.
  • Glycosylated hemoglobin (A1c) >7.0% and ≤8.5% at screening.
  • Male or female ≥18 years of age.
  • Women of childbearing potential must have been using an adequate method of contraception to avoid pregnancy throughout the study, and for up to 4 weeks after study completion.
  • Fasting C-peptide level >0.5 ng/mL at screening.
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  • Currently being treated with a stable dose of an approved non-thiazolidinedione antihyperglycemic medication (including sulfonylureas, meglitinides, insulin secretagogues, metformin, or α-glucosidase inhibitors) given as monotherapy, for at least 3 months prior to screening, and could discontinue that antihyperglycemic medication at Visit 2 (Week -2) and for the duration of the study. OR
  • Untreated and had not taken any antihyperglycemic agent during the 2 months prior to screening; if not treated with an oral antihyperglycemic agent, the participant was considered by the investigator to have failed diet and exercise modification as the sole treatment for type 2 diabetes mellitus.
  • Clinically stable in regard to medical conditions other than type 2 diabetes mellitus.
  • Concomitant medications (other than oral antihyperglycemic agents) were at stable doses for at least 30 days prior to enrollment and were not anticipated to need adjustment during the study period.

Who cannot join

  • History of type 1 diabetes and/or history of ketoacidosis.
  • History of long-term (>2 months) therapy with insulin.
  • History of prior treatment failure with, or intolerance of, a thiazolidinedione (ie, rosiglitazone, troglitazone, or pioglitazone).
  • Treatment with a fibrate lipid-lowering agent (eg, fenofibrate, gemfibrozil).
  • Confirmed repeat fasting glucose (≥2 readings of fasting blood glucose) >240 mg/dL (13.3 mmol/L) during the 2-week washout/stabilization and placebo run-in period (Period A).
  • Body mass index (BMI) >45 kg/m2 at screening.
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  • History of weight loss >10% over the 3 months prior to screening.
  • Female participant who was pregnant or breastfeeding.
  • Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure
  • ≥110 mmHg.
  • Any known history of congestive heart failure prior to screening.
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening. History of malignancy (except participants who had been disease-free for >10 years), or whose malignancy was a basal or squamous cell skin carcinoma. Any history of bladder cancer was an exclusion from participation. Women with a history of cervical dysplasia (CIN2 or higher) were to be excluded unless 2 consecutive normal cervical smears had subsequently been recorded prior to enrollment.
  • Impaired liver function including evidence of acute or chronic hepatitis or liver disease by medical history, clinical signs or symptoms, or laboratory results.
  • Evidence for ongoing infectious liver disease with positive hepatitis A antigen or immunoglobulin M antibody, hepatitis B surface antigen, or antibodies to hepatitis C virus. Participants with normal liver function tests and isolated positive antibodies to hepatitis B virus could have been included.
  • Known (or evidence of) infection with human immunodeficiency virus.
  • Known hemoglobinopathy or chronic anemia that required specific treatment within 5 years of the screening visit.
  • History of alcohol or drug abuse within 1 year prior to screening.
  • History of unstable major psychiatric disorders. Known or suspected allergy or hypersensitivity to thiazolidinedione agents.
  • Clinically significant abnormalities in any pre-randomization laboratory analyses that, in the investigator's opinion, comprised an undue risk with the participant's participation, or could potentially confound results of the study.
  • Unexplained hematuria (>3 red blood cells per high-powered field by urine microscopy).
  • Blood donation of ≥1 pint (0.5 liter) within the past 30 days prior to screening or plasma donation within 7 days prior to the screening visit (Visit 1).
  • Prior known or possible exposure to rivoglitazone.
  • Contraindication to treatment with pioglitazone once daily.
  • Known or suspected allergy, hypersensitivity, or intolerance to the excipients of the investigational study medication.
  • Participation in an interventional medical, surgical, or pharmaceutical study within 30 days prior to the screening visit (Visit 1).
  • Any condition or concomitant therapy that, in the opinion of the investigator, might have posed a risk to the participant or made participation not in the participant's best interest.
  • A direct or familial relationship with the Sponsor, investigator, or site personnel affiliated with the study.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Daingerfield, Texas, 75638

  • Study site

    Dallas, Texas, 75216

  • Study site

    Fleetwood, Pennsylvania, 19522

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Harrisburg, Pennsylvania, 17112

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Plano, Texas, 75093

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Ridgefield, Connecticut, 06877

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Diego, California, 92128

  • Study site

    San Francisco, California, 94115

  • Study site

    Simpsonville, South Carolina, 29681

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo, and Active Comparator-controlled, Parallel-group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

Being tested
Rivoglitazone HCl, placebo, pioglitazone HCl, pioglitazone HCl 45 mg, metformin
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

    Also called CS-011

    0.5 mg tablets administered orally, once daily

  • rivoglitazone HClDrug

    Also called CS-011

    1.0 mg tablets administered orally, once daily

  • rivoglitazone HClDrug

    Also called CS-011

    1.5 mg tablets administered orally, once daily

  • placeboDrug

    placebo tablets matching rivoglitazone tablets administered orally, once daily

  • pioglitazone HClDrug

    15 mg capsules administered orally, once daily

  • pioglitazone HClDrug

    30 mg capsules administered orally, once daily

  • pioglitazone HCl 45 mgDrug

    45 mg capsules administered orally, once daily

  • placeboDrug

    placebo capsules for pioglitazone administered orally, once daily

  • metforminDrug

    Oral tablets. Rescue medication.

Study groups in NCT00571519
Study groupRoleWhat they receive
1Experimentalrivoglitazone HCl 0.5mg
Receives: Drug: Rivoglitazone HCl; Drug: metformin
2Experimentalrivoglitazone HCl 1.0 mg
Receives: Drug: rivoglitazone HCl; Drug: metformin
3Experimentalrivoglitazone HCl 1.5 mg
Receives: Drug: rivoglitazone HCl; Drug: metformin
4Placebo comparatorplacebo matching rivoglitazone HCl tablets
Receives: Drug: placebo; Drug: metformin
5Active comparatorpioglitazone HCl 15 mg
Receives: Drug: pioglitazone HCl; Drug: metformin
6Active comparatorpioglitazone HCl 30 mg
Receives: Drug: pioglitazone HCl; Drug: metformin
7Active comparatorpioglitazone HCl 45 mg
Receives: Drug: pioglitazone HCl 45 mg; Drug: metformin
8Placebo comparatormatching placebo for pioglitazone
Receives: Drug: placebo; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are <7.0% and <6.5%.

    Measured: Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.

Secondary outcomes (14)

  1. Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Normal fasting plasma glucose (FPG) -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline and a lower FPG means improvement.

    Measured: Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose.

  2. Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.

    Measured: Baseline up to week 12 post-dose.

  3. Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.

    Measured: Baseline up to week 12 post-dose.

  4. Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement.

    Measured: Baseline up to week 12 post-dose.

  5. Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement.

    Measured: Baseline up to week 12 post-dose.

  6. Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement.

    Measured: Baseline up to week 12 post-dose.

  7. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement.

    Measured: Baseline up to week 12 post-dose.

  8. Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement.

    Measured: Baseline up to week 12 post-dose.

  9. Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement.

    Measured: Baseline up to week 12 post-dose.

  10. Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel.

    Measured: Baseline up to week 12 post-dose.

  11. Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel.

    Measured: Baseline up to week 12 post-dose.

  12. Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.

    Measured: Baseline up to week 12 post-dose.

  13. Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.

    Measured: Baseline up to week 12 post-dose.

  14. Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

    Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.

    Measured: Baseline up to week 26 post-dose, approximately a total of 27 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2007 (estimated)
  2. Study start14 Nov 2007
  3. Primary completion23 May 2008
  4. Study completion23 May 2008

Why it stopped: DSPD focusing on Study 301 to confirm the clinical profile before proceeding. Daiichi Sankyo Pharma Development terminated this study on 23 Apr 2008 because of changes in the clinical development plan with 94 of 2600 planned, randomized participants.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00571519
Sponsor's protocol ID
CS0011-A-U302
Status last verified
May 2021
First submitted
11 Dec 2007
Last updated
26 May 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivoglitazone HCl, pioglitazone HCl and pioglitazone HCl 45 mg in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 18 sites in United States.

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 10 inclusion and 27 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: stopped early, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus (time frame: Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00571519.

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 26 May 2021.

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