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Diabetes MellitusPhase 3NCT00763022

Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing TAK-559 in people with Diabetes Mellitus, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to determine the safety and efficacy of TAK-559, once daily (QD), in Type 2 Diabetes subjects. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
TAK-559
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
No sites listed yet
Study dates
Nov 2003to Dec 2004
Phase
Phase 3
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 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A.
  • Had a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B.
  • Had a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B.
  • Was taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B.
  • Was on a stable or worsening self-monitoring blood glucose level while taking glyburide.
  • Had a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
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  • Had a body mass index less than or equal to 45 kg/m2 at Screening A.
  • Was willing to be counseled by the investigator or designee to follow an individualized, weight-maintaining diet during the study period.
  • Had evidence of insulin secretory capacity as demonstrated by a C-peptide concentration of greater than or equal to 1.5 ng/mL (0.50 nmol/L) at Screening A, and if necessary, after a repeat at Screening B.
  • Was able to perform daily self-monitoring blood glucose tests throughout the study.
  • Had a normal thyroid-stimulating hormone level of less than 5.5 uIU/mL (5.5 mIU/L) and greater than or equal to 0.35 uIU/mL (0.35 mIU/L) at Screening A.
  • Was in good health as determined by a physician (ie, via medical history and physical examination), other than a diagnosis of type 2 diabetes mellitus.
  • Had fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to Randomization.
  • Females were post menopausal, surgically sterile, or using adequate contraception.

Who cannot join

  • Was diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis.
  • Had any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies).
  • Was required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Insulin
  • Oral anti-diabetics other than TAK-559 (including sulfonylureas other than glyburide, alpha-glucosidase inhibitors, metformin)
  • Systemic corticosteroids
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  • Warfarin
  • Rifampin
  • St. John's Wort.
  • Thiazolidinediones
  • Peroxisome proliferator-activated receptor agonists
  • Nicotinic Acid
  • Fibrates
  • Had a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal electrocardiogram, or documented cerebrovascular accident within 6 months prior to Screening A.
  • Had abdominal, thoracic, or vascular surgery within 6 months prior to Screening A that in the investigator's opinion would warrant exclusion from the study.
  • Had a creatine phosphokinase value greater than 3 times the upper limit of normal at Screening A. The creatine phosphokinase value can be retested prior to Randomization if elevated.
  • Had persistent unexplained microscopic or macroscopic hematuria or a history of bladder cancer.
  • Had a triglyceride level greater than 500 mg/dL (5.6 mmol/L) at Screening A.
  • Had any alteration in allowed lipid lowering medication (dose or drug) within 2 months of Randomization, if applicable.
  • Had donated and/or received any blood or blood products within 3 months prior to Randomization.
  • Had a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 2 years prior to Randomization.
  • Had a systolic BP greater than 140 mm Hg or a diastolic blood pressure of greater than 95 mm Hg at Screening B.
  • Had significant cardiovascular disease including but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV.
  • Had a previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to Randomization.
  • Had an alanine transaminase or aspartate transaminase level greater than 3 times the upper limit of normal, active liver disease, or jaundice at Screening A.
  • Had a positive human immunodeficiency virus, hepatitis B surface antigen, or hepatitis B e antigen test at Screening A.
  • Had any other serious disease or condition at Screening A or at Randomization that might affect life expectancy or make it difficult to successfully manage and follow the patient according to the protocol.

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study of the Safety and Efficacy of TAK-559 Compared to Placebo in the Treatment of Patients With Type 2 Diabetes Mellitus

The purpose of this study was to determine the safety and efficacy of TAK-559, once daily (QD), in Type 2 Diabetes subjects.

Read the detailed description

Insulin is a primary regulator of blood glucose concentrations. A subnormal response to circulating insulin levels at target tissues leads to a decrease in insulin-mediated glucose uptake. Insulin resistance is associated with normal to high insulin levels and is often accompanied by dyslipidemia, a disruption in lipid metabolism resulting in increased triglycerides and low-density lipoprotein levels as well as decreased high-density lipoprotein levels in patients with type 2 diabetes mellitus. In the early stages of insulin resistance, a compensatory mechanism of increased insulin secretion by the pancreas maintains normal to near-normal glucose levels. Once the pancreas fails to maintain the increased insulin output, overt type 2 diabetes mellitus occurs.

TAK-559 is a novel oxyiminoalkanoic acid under investigation for use as an oral agent in the treatment of patients with type 2 diabetes mellitus. TAK-559 has partial peroxisome proliferator-activated receptor-alpha agonist activity, potent peroxisome proliferator-activated receptor-alpha activity, and modest peroxisome proliferator-activated receptor-gamma activity at high concentrations in nonclinical models.

This study was designed to evaluate the safety and glycemic control of TAK-559 in patients with type 2 diabetes mellitus whose symptoms were managed by diet and exercise.

Being tested
TAK-559, 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-559Drug

    TAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.

  • TAK-559Drug

    TAK-559 32 mg, tablets, orally, once daily for up to 26 weeks.

  • PlaceboDrug

    TAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.

Study groups in NCT00763022
Study groupRoleWhat they receive
TAK-559 16 mg QDExperimentalNot described
Receives: Drug: TAK-559
TAK-559 32mg QDExperimentalNot described
Receives: Drug: TAK-559
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in Baseline in Glycosylated hemoglobin.

    Measured: Weeks: 4, 8, 12, 16, 20 and Final Visit.

Secondary outcomes (13)

  1. Change in Baseline in Glycosylated hemoglobin.

    Measured: Weeks: 4, 8, 12, 16, 20 and Final Visit.

  2. Change in Baseline in Fasting Plasma Glucose.

    Measured: Weeks: 2, 4, 8, 12, 16, 20 and Final Visit.

  3. Change in Baseline in Serum insulin.

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  4. Change in Baseline in C-peptide.

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  5. Change in Baseline in Lipids (triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, very-low-density lipoprotein).

    Measured: Weeks: 12, 16, 20 and Final Visit.

  6. Change in Baseline in Lipids (low-density lipoprotein fractionation).

    Measured: Weeks: 12, 16, 20 and Final Visit.

  7. Change in Baseline in Apolipoproteins Al and B100.

    Measured: Final Visit.

  8. Change in Baseline in Free fatty acids.

    Measured: Weeks: 12, 16, 20 and Final Visit.

  9. Markers of thrombosis (plasminogen activator inhibitor-i).

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  10. Markers of thrombosis (fibrinogen).

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  11. Markers of inflammation (interleukin-6).

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  12. Markers of inflammation (C-reactive protein).

    Measured: Weeks: 4, 12, 16, 20 and Final Visit.

  13. Urinary albumin/creatinine ratio.

    Measured: Weeks: 12, 16, 20 and Final Visit.

Timeline

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

  1. First posted30 Sep 2008 (estimated)
  2. Study startNov 2003
  3. Primary completionDec 2004
  4. Study completionDec 2004

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00763022
Sponsor's protocol ID
01-02-TL-559-014
Other IDs
U1111-1127-8487
Status last verified
Nov 2012
First submitted
26 Sep 2008
Last updated
12 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-559 in people with Diabetes Mellitus, run by Takeda.

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 14 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: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

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 Baseline in Glycosylated hemoglobin. (time frame: Weeks: 4, 8, 12, 16, 20 and Final Visit.). 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 NCT00763022.

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 12 Nov 2012.

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