Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.

NCT00759720 | Terminated Phase 3

• 2 other identifiers: 01-02-TL-559-013U1111-1127-8392
• Study Type: interventional
• Target: 447
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy of TAK-559, once daily (QD), combined with glyburide in treating 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 (1)

• Change from Baseline in Glycosylated hemoglobin level.

  Final Visit

Secondary Outcomes (11)

• Change from baseline in Glycosylated hemoglobin level.

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

• Change from baseline in Fasting plasma glucose.

  At all Visits.

• Change from Baseline in Serum insulin.

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

• Change from Baseline in C-peptide.

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

• Change from Baseline in Lipids (triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein and very low-density lipoproteins)

  Weeks: 12, 16, 20 and Final Visit.

Study Arms (3)

TAK-559 16 mg QD + Glyburide QD

EXPERIMENTAL

Drug: TAK-559 and glyburide

TAK-559 32 mg QD + Glyburide QD

EXPERIMENTAL

Drug: TAK-559 and glyburide

Glyburide QD

ACTIVE COMPARATOR

Drug: Glyburide

Interventions

TAK-559 and glyburide DRUG

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

Also known as: Glibenclamide, Diabeta, Glynase, Micronase, Daonil, Semi-Daonil, Euglucon

TAK-559 16 mg QD + Glyburide QD

Glyburide DRUG

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

Also known as: Glibenclamide, Diabeta, Glynase, Micronase, Daonil, Semi-Daonil, Euglucon

Glyburide 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:

• Must be 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.
• Has a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B.
• Has a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B.
• Is taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B.
• Has a stable or worsening self-monitoring blood glucose level while taking glyburide.
• The patient must have a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
• Has a body mass index less than or equal to 45 kg/m2 at Screening A.
• Is willing to be counseled by the investigator or designee to follow an individualized, weight-maintaining diet during the study period.
• Has 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.
• The patient must be able to perform daily self-monitoring blood glucose tests throughout the study.
• Has 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.
• Is in good health as determined by a physician (ie, via medical history and physical examination), other than a diagnosis of type 2 diabetes mellitus.
• Has 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 must be post menopausal, surgically sterile, or using adequate contraception.

You may not qualify if:

• Has been diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis.
• Has any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies).
• Is 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
• Has 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.
• Has 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; Glyburide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Sr VP Clinical Research

  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 24, 2008
• First Posted: September 25, 2008
• Study Start: November 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 2, 2012

Record last verified: 2012-02