Safety and Efficacy of TAK-559 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus.

NCT00762957 | Terminated Phase 3

• 2 other identifiers: 01-04-TL-559-029U1111-1128-4945
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TAK-559, once daily (QD), taken in combination with metformin in treating subjects with type 2 diabetes mellitus

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.

  Final Visit.

Secondary Outcomes (16)

• Change from baseline in glycosylated hemoglobin.

  Weeks 2, 4, 8, 12, 16 and 20

• Change from baseline in fasting plasma glucose.

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

• 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 triglycerides.

  Weeks 12, 16, 20 and Final Visit.

Study Arms (3)

TAK-559 16 mg QD + Metformin QD

EXPERIMENTAL

Drug: TAK-559 and metformin

TAK-559 32 mg QD + Metformin QD

EXPERIMENTAL

Drug: TAK-559 and metformin

Metformin QD

ACTIVE COMPARATOR

Drug: Metformin

Interventions

TAK-559 and metformin DRUG

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

TAK-559 16 mg QD + Metformin QD

Metformin DRUG

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

Metformin 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:

• Diagnosed with type 2 diabetes mellitus, and on a stable dose of an oral antidiabetic monotherapy before Screening A.
• Female patients of childbearing potential who were sexually active agreed to use adequate contraception, and could neither pregnant nor lactating from Screening throughout the duration of the study.
• 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.
• Taking a stable dose of at least 1000 mg of metformin for at least 30 days before Screening B.
• Had a stable or worsening self-monitoring blood glucose level while taking metformin.
• Had a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
• Had a body mass index was 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 μIU/mL (5.5 mIU/L) and greater than or equal to 0.35 μIU/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 results within the normal ranges for the testing laboratory, or if not, the results were deemed not clinically significant by the investigator before Randomization.

You may not qualify if:

• Diagnosed with type 1 diabetes mellitus, hemochromatosis, or had a history of ketoacidosis.
• Had any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states or hemoglobinopathies).
• Took any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may have interfered with evaluation of the study medication, including:
• Insulin
• Oral antidiabetics including sulfonylureas and alpha-glucosidase inhibitors
• 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 before Screening A.
• Had a creatine phosphokinase value greater than 3 times the upper limit of normal at Screening A.

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; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• VP Biological Sciences

  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, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 28, 2012

Record last verified: 2012-02