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

NCT00763022 | Completed Phase 3

• 2 other identifiers: 01-02-TL-559-014U1111-1127-8487
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Baseline in Glycosylated hemoglobin.

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

Secondary Outcomes (13)

• Change in Baseline in Glycosylated hemoglobin.

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

• Change in Baseline in Fasting Plasma Glucose.

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

• Change in Baseline in Serum insulin.

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

• Change in Baseline in C-peptide.

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

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

  Weeks: 12, 16, 20 and Final Visit.

Study Arms (3)

TAK-559 16 mg QD

EXPERIMENTAL

Drug: TAK-559

TAK-559 32mg QD

EXPERIMENTAL

Drug: TAK-559

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-559 DRUG

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

TAK-559 16 mg QD

Placebo DRUG

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

Placebo QD

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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 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.

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

• Sr VP Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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