Diabetes MellitusPhase 2NCT00722917
Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing TAK-379 and Pioglitazone in people with Diabetes Mellitus, run by Takeda at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- TAK-379 and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2008to Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy and an 8 week history of diet and exercise.
- Historical diagnosis of type 2 diabetes mellitus on a stable dose of metformin as mono-therapy for at least 3 months prior to screening.
- Glycosylated hemoglobin between 7.5% and 10.0%, inclusive.
- Fasting C-peptide concentration is greater than or equal to 0.8 ng per mL.
- Any other chronic medications which have been stable for at least 4 weeks prior to Screening.
- Body mass index at Screening is greater than or equal to 23 kg/m2 and less than 45 kg/m2.
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- Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Compliance with single-blinded study medication during the run-in phase is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.
Who cannot join
- Systolic blood pressure is greater than 160 mm Hg, or diastolic pressure is greater than 100 mm Hg at repeat measurements.
- Any history of bladder cancer or has a history of cancer that has been in remission for less than 5 years prior to Screening (a history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed).
- Glycosylated hemoglobin is less than 7.5% and greater than 10.0%.
- Creatine phosphokinase is greater than or equal to 5 times the upper limit of normal at screening.
- Hemoglobin is less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
- Alanine aminotransferase and aspartate aminotransferase are greater than or equal to 2.5 upper limit of normal.
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- Total bilirubin is greater than or equal to 1.5 times the upper limit of normal at screening.
- Serum triglyceride concentration is greater than or equal to 400 mg per dL.
- Estimated glomerular filtration rate is less than or equal to 60 mL per min using the Modification of Diet in Renal Disease equation or the Cockroft-Gault equation.
- Abnormal thyroid-stimulating hormone as defined by central laboratory normals.
- Positive test result for hepatitis B surface antigen or hepatitis C antibody.
- Urine albumin to creatinine ratio is greater than or equal to 1000 μg per mg at screening.
- History of microscopic or macroscopic hematuria.
- Two consecutive unexplained positive urinalysis dip-stick and greater than or equal to 3 red blood cells per high-powered field on two consecutive measurements.
- History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- Diabetic gastroparesis that in the investigator's opinion is moderate or severe and hence may impair absorption of study medication.
- The subject has New York Heart Association Class III or IV heart failure.
- Has had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 6 months prior or at Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- Received treatment with probucol within 1 year of randomization.
- Donated or received any blood products within 12 weeks prior to Screening.
- Received treatment for greater than 7 days within 8 weeks prior to randomization or is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- oral or systemically injected glucocorticoids
- Prescription or over the counter weight-loss drugs
- Peroxisome proliferator-activated receptor agonists, including fibric acid derivatives
- Niacin
- Ezetemibe
- Bile-acid binding agents
- warfarin
- phenytoin
- any alteration in lipid-lowering medication (change in dosage or drug)
- Chronically treated with insulin.
- Received any investigation drug within 4 weeks prior to Screening.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- Hypersensitive to TAK-379 or its excipients.
- History of drug abuse or a history of alcohol abuse within 2 years prior to Screening.
- Any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the subject according to the protocol.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Artesia, California
Study site
Cranston, Rhode Island
Study site
Dallas, Texas
Study site
Houston, Texas
Study site
Norwalk, California
Study site
Panama City, Florida
Study site
Santa Ana, California
Study site
Santa Monica, California
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.
Read the detailed description
Type 2 diabetes is a metabolic disease that has reached epidemic proportions. The global incidence of this disease is estimated to increase from 120 million individuals to over 200 million by the year 2010. In type 2 diabetes, multiple metabolic defects contribute to hyperglycemia. These include insulin resistance, inadequate insulin secretion, and excessive hepatic glucose production. Nine classes of antihyperglycemic agents are currently approved for the treatment of type 2 diabetes (insulin, sulfonylureas, biguanides, alpha-glycosidase inhibitors, thiazolidinediones, glinides, glucagon-like peptide analogues, amylin analogues, and dipeptidyl peptidase 4 inhibitors). Each class acts by a unique mechanism on 1 or more of the metabolic defects.
Takeda Pharmaceutical Company Limited is developing TAK-379, a non-thiazolidinedione partial proliferator-activated receptor agonist for the treatment of type 2 diabetes mellitus. Study participation is anticipated to be approximately 4.5 months.
- Conditions
- Diabetes Mellitus
- Being tested
- TAK-379, Pioglitazone, Placebo
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-379Drug
Also called Actos
TAK-379 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
TAK-379Drug
Also called Actos
TAK-379 100 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
TAK-379Drug
Also called Actos
TAK-379 200 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
PioglitazoneDrug
Also called Actos, AD4833
Pioglitazone 30 mg, tablets, orally, once daily and TAK-379 placebo-matching tablets, orally, once daily for up to 12 weeks
PlaceboDrug
TAK-379 placebo-matching tablets, orally, and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| TAK-379 25 mg QD | Experimental | Not described Receives: Drug: TAK-379 |
| TAK-379 100 mg QD | Experimental | Not described Receives: Drug: TAK-379 |
| TAK-379 200 mg QD | Experimental | Not described Receives: Drug: TAK-379 |
| Pioglitazone 30 mg QD | Active comparator | Not described Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glycosylated Hemoglobin
Measured: Week 12 or Final Visit
Secondary outcomes (5)
Change from baseline in glycosylated hemoglobin.
Measured: Weeks 4 and 8 or Final Visit
Change from baseline in fasting plasma glucose.
Measured: Weeks 1, 2, 4, 8 and 12 or Final Visit
Change from baseline in body weight.
Measured: Weeks 4, 8 and 12 or Final Visit
Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment.
Measured: Week 12 or Final Visit
Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach.
Measured: Week 12 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Animal Toxicity Findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722917
- Sponsor's protocol ID
- TAK-379_201
- Other IDs
- U1111-1125-0948
- Status last verified
- Jun 2016
- First submitted
- 24 Jul 2008
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00722917
- Acronym / sponsor ID
- TAK-379_201
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Animal Toxicity Findings
- Enrolment
- 323 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Jul 2008 (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 evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.
Detailed description
Type 2 diabetes is a metabolic disease that has reached epidemic proportions. The global incidence of this disease is estimated to increase from 120 million individuals to over 200 million by the year 2010. In type 2 diabetes, multiple metabolic defects contribute to hyperglycemia. These include insulin resistance, inadequate insulin secretion, and excessive hepatic glucose production. Nine classes of antihyperglycemic agents are currently approved for the treatment of type 2 diabetes (insulin, sulfonylureas, biguanides, alpha-glycosidase inhibitors, thiazolidinediones, glinides, glucagon-like peptide analogues, amylin analogues, and dipeptidyl peptidase 4 inhibitors). Each class acts by a unique mechanism on 1 or more of the metabolic defects.
Takeda Pharmaceutical Company Limited is developing TAK-379, a non-thiazolidinedione partial proliferator-activated receptor agonist for the treatment of type 2 diabetes mellitus. Study participation is anticipated to be approximately 4.5 months.
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 |
|---|---|---|
| TAK-379 25 mg QD | Experimental | Drug: TAK-379 |
| TAK-379 100 mg QD | Experimental | Drug: TAK-379 |
| TAK-379 200 mg QD | Experimental | Drug: TAK-379 |
| Pioglitazone 30 mg QD | Active comparator | Drug: Pioglitazone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy and an 8 week history of diet and exercise.
- Historical diagnosis of type 2 diabetes mellitus on a stable dose of metformin as mono-therapy for at least 3 months prior to screening.
- Glycosylated hemoglobin between 7.5% and 10.0%, inclusive.
- Fasting C-peptide concentration is greater than or equal to 0.8 ng per mL.
- Any other chronic medications which have been stable for at least 4 weeks prior to Screening.
Key exclusion criteria (37 listed)
- Systolic blood pressure is greater than 160 mm Hg, or diastolic pressure is greater than 100 mm Hg at repeat measurements.
- Any history of bladder cancer or has a history of cancer that has been in remission for less than 5 years prior to Screening (a history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed).
- Glycosylated hemoglobin is less than 7.5% and greater than 10.0%.
- Creatine phosphokinase is greater than or equal to 5 times the upper limit of normal at screening.
- Hemoglobin is less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
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 |
|---|---|---|
| TAK-379Also: ActosTAK-379 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | TAK-379 25 mg QD |
| TAK-379Also: ActosTAK-379 100 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | TAK-379 100 mg QD |
| TAK-379Also: ActosTAK-379 200 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | TAK-379 200 mg QD |
| PioglitazoneAlso: Actos, AD4833Pioglitazone 30 mg, tablets, orally, once daily and TAK-379 placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | Pioglitazone 30 mg QD |
| PlaceboTAK-379 placebo-matching tablets, orally, and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | Placebo |
Primary outcome
Change from Baseline in Glycosylated Hemoglobin
Time frame: Week 12 or Final Visit
5 secondary outcomes
Change from baseline in glycosylated hemoglobin.
Time frame: Weeks 4 and 8 or Final Visit
Change from baseline in fasting plasma glucose.
Time frame: Weeks 1, 2, 4, 8 and 12 or Final Visit
Change from baseline in body weight.
Time frame: Weeks 4, 8 and 12 or Final Visit
Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment.
Time frame: Week 12 or Final Visit
Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach.
Time frame: Week 12 or Final Visit
Results and safety
The study was stopped early (reason given: Animal Toxicity Findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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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.
Medical Director Clinical Science study director
Takeda
8 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 TAK-379 and Pioglitazone in people with Diabetes Mellitus, run by Takeda at 8 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 9 inclusion and 37 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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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 was stopped early (reason given: Animal Toxicity Findings). Results are not available in the source record.
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 from Baseline in Glycosylated Hemoglobin (time frame: Week 12 or Final Visit). 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 22 Jun 2016.