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

NCT00762190 | Terminated Phase 3

• 2 other identifiers: 01-03-TL-559-016U1111-1128-1034
• Study Type: interventional
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine the safety of TAK-559, once daily (QD), in treating subjects receiving a stable dose of insulin to control 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 (7)

• Incidence of Adverse events.

  All visits or at occurrence.

• Clinical safety lab tests.

  Weeks 12, 24, and Final Visit.

• 12-lead electrocardiogram.

  Weeks: 24 and Final Visit.

• Urinalysis.

  Weeks: 12, 24, 36, 48 and Final Visit.

• Change from Baseline in Blood pressure and pulse.

  At all visits.

• Change from Baseline in Body weight.

  At all visits.

• Left ventricular mass index by body surface area measured by echocardiogram.

  Weeks: 24 and Final Visit.

Secondary Outcomes (9)

• Change from Baseline in total daily dose of insulin.

  At all visits.

• Change from Baseline in triglycerides.

  Weeks: 24 and Final Visit.

• Change from Baseline in cholesterol.

  Weeks 24 and Final Visit

• Change from Baseline in total, high-density lipoproteins.

  Weeks: 24 and Final Visit.

• Change from Baseline in low-density lipoproteins.

  Weeks 24 and Final Visit

Study Arms (2)

TAK-559 32 mg QD + Insulin

EXPERIMENTAL

Drug: TAK-559 and insulin

Insulin

ACTIVE COMPARATOR

Drug: Insulin

Interventions

TAK-559 and insulin DRUG

TAK-559 32 mg, tablets, orally, once daily and insulin stable dose injection for up to 54 weeks.

TAK-559 32 mg QD + Insulin

Insulin DRUG

TAK-559 placebo-matching, tablets, orally, once daily and insulin stable dose injection for up to 54 weeks.

Insulin

Eligibility Criteria

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

You may qualify if:

• Had type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, currently treated with insulin therapy.
• Required sponsor approval if older than 65 years.
• Had a Screening glycosylated hemoglobin less than or equal to 8.0%.
• Had a Screening fasting plasma glucose less than or equal to 200 mg/dL (11.1 mmol/L).
• Had a Screening low density lipoprotein less than or equal to 160 mg/dL (4.1 mmol/L).
• Had a Screening thyroid stimulating hormone level less than or equal to 5.5 μU/mL (5.5 μU/L) and greater than or equal to 0.35 μU/mL (0.35 μU/L).
• Was willing to continue dietary counseling during study and had dietary advice greater than or equal to 2.5 months prior to Screening.
• Had a Screening ejection fraction greater than or equal to 40% from echocardiogram.
• Had a Screening blood pressure less than or equal to 140/95 mm Hg.
• Was willing to perform daily self-monitoring blood glucose tests.
• 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.
• Was in good health as determined by physician (via medical history and physical examination) other than having type 2 diabetes mellitus.
• Had clinical laboratory evaluations within normal reference range or deemed not clinically significant by the investigator or sponsor.
• Started insulin therapy at least 3 months prior to Randomization.

You may not qualify if:

• Had a hypersensitivity to peroxisome proliferator-activated receptor -alpha or gamma agonists, thiazolidinediones, or fibrates.
• Was diagnosed with type 1 diabetes mellitus or hemochromatosis, or had a history of ketoacidosis.
• Required greater than 2 hypertension medications to achieve adequate blood pressure control.
• Had a history of coronary angioplasty or bypass graft, or unstable angina pectoris within 1 year of Screening.
• Had a history of myocardial infarction.
• Had a history of transient ischemic attack or documented cerebrovascular accident within 6 months of Screening.
• Had a screening creatine phosphokinase value greater than 3 times the upper limit of normal.
• Had persistent unexplained microscopic or macroscopic hematuria or history of bladder cancer.
• Had a screening triglyceride level greater than 500 mg/dL (5.6 mmol/L).
• Experienced a change in allowed lipid-lowering medication (dose or drug) within 2 months of Randomization.
• Experienced a change in blood pressure medication (dose or drug) within 1 month of Randomization.
• Had systemic corticosteroids within 1 month of Randomization.
• Had donated or received blood products within 3 months of Randomization.
• Had a condition known to invalidate glycosylated hemoglobin.
• Had a history of drug abuse or alcohol abuse within 2 years.

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; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 12, 2012

Record last verified: 2012-11