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

NCT00762112 | Terminated Phase 3

• 2 other identifiers: 01-03-TL-559-017U1111-1128-4850
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy.

Outcome Measures

Primary Outcomes (8)

• Change from baseline in clinical laboratory hematology tests.

  Week 2 and Months 6, 12, 18, and Final Visit

• Change from baseline in clinical laboratory chemistry tests.

  Week 2 and Months 6, 12, 18, and Final Visit

• Blood pressure measurements.

  All visits.

• Pulse measurements.

  All visits.

• Body weight.

  All visits.

• Physical examinations.

  Months 6, 12, 18, and Final Visit

• 12-lead electrocardiogram.

  Months 6, 12, and Final Visit

• Adverse event occurrence.

  All visits or at occurrence

Secondary Outcomes (21)

• Change from baseline in glycosylated hemoglobin.

  Months 3, 6, 9, 12, 15, 18, 21, and Final Visit

• Change from baseline in fasting plasma glucose.

  All visits.

• Change from baseline in fasting insulin.

  Months 3, 6, 9, 12, 15, 18, 21, and Final Visit

• Change from baseline in fasting C-peptide.

  Months 6, 12, 18, and Final Visit

• Change from baseline in triglycerides.

  Months 6, 12, 18, and Final Visit

Study Arms (1)

TAK-559 32 mg QD

EXPERIMENTAL

Drug: TAK-559

Interventions

TAK-559 DRUG

TAK-559 32 mg, tablets, orally, once daily for up to 24 months.

TAK-559 32 mg QD

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Required sponsor approval if older than 80 years.
• Had either:
• Successfully completed Protocol 01-03-TL-559-016, or
• Participated in either Protocol 01-02-TL-559-013, 01-02-TL-559-014, 01-04-TL-559-028, or 01-04-TL-559-029 and either
• completed the study
• prematurely terminated from the study due to the HbA1c withdrawal criterion after at least 12 weeks of treatment, or
• in the opinion of the investigator, demonstrated a lack of efficacy after at least 16 weeks of treatment and was withdrawn from the study.
• A female subject of childbearing potential who was sexually active agreed to use adequate contraception, and was neither pregnant nor lactating from Screening throughout the duration of the study.
• Were willing to continue following an individualized weight maintenance diet during the study period.
• Had evidence of insulin secretory capacity, as demonstrated by a fasting C-peptide concentration of greater than or equal to 1.5 ng/mL (0.50 nmol/L) at the prior visit of Protocol 013, 014, 016, 028, or 029.
• Were willing to perform daily self-monitoring blood glucose tests.
• Were in good health at Enrollment, as determined by a physician at the final visit of Protocol 013, 014, 016, 028, or 029 (ie, via medical history and physical examination), other than having type 2 diabetes mellitus and New York Heart Association Classification I or II congestive heart failure.
• Had clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis after fasting for at least 8 hours) within the normal reference range for the testing laboratory, unless the results were deemed not clinically significant by the investigator or sponsor, at the prior visit of Protocol 013, 014, 016, 028, or 029.
• 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 the prior visit of Protocol 013, 014, 016, 028, or 029.

You may not qualify if:

• Had significant cardiovascular disease, including, but not limited to, New York Heart Association Classification III or IV CHF at Enrollment.
• Had a planned surgical or catheter intervention for coronary angioplasty within 12 months after the Enrollment Visit.
• Had a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 95 mm Hg at Enrollment.
• Had symptomatic orthostatic hypotension or systolic blood pressure less than 90 mm Hg at Enrollment.
• Had a history of a clinically significant abnormal electrocardiogram or experienced any cardiovascular event including, but not limited to, myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, or documented cerebrovascular accident during Protocol 013, 014, 016, 028, or 029.
• Had a creatine phosphokinase value above 3 times the upper limit of normal at the prior visit of Protocol 013, 014, 016, 028, or 029.
• Had a triglyceride level greater than 500 mg/dL (5.6 nmol/L) at the prior visit of Protocol 013, 014, 016, 028, or 029.
• Had an alanine aminotransferase or aspartate aminotransferase level above 3 times the upper limit of normal, active liver disease, or jaundice at any time during Protocol 013, 014, 016, 028, or 029.
• Had donated and/or received any blood products within 3 months prior to Enrollment.
• Had used illicit drugs or abused alcohol during participation in Protocol 013, 014, 016, 028, or 029.
• Had experienced another illness occurring at the same time requiring hospitalization during the occurring at the same time 3 weeks before the Enrollment Visit.
• Had experienced any other serious disease or condition during participation in Protocol 013, 014, 016, 028, or 029 that might have affected life expectancy or made it difficult to successfully manage and follow the patient according to the protocol.
• Was required to take or intended to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfered with the evaluation of the study medication, including:
• insulin (for patients who participated in Protocol 01-02-TL-559-013, 01-02-TL-559-014, 01-04-TL-559-028, and 01-04-TL-559-029)
• prescription-strength niacin

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

(E)-4-(4-((5-methyl-2-phenyl-1,3-oxazol-4-yl)methoxy)benzyloxyimino)-4-phenylbutyric acid

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: November 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 12, 2012

Record last verified: 2012-11