Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes Mellitus

NCT00722917 | Terminated Phase 2

• 2 other identifiers: TAK-379_201U1111-1125-0948
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in 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

  Week 12 or Final Visit

Secondary Outcomes (5)

• Change from baseline in glycosylated hemoglobin.

  Weeks 4 and 8 or Final Visit

• Change from baseline in fasting plasma glucose.

  Weeks 1, 2, 4, 8 and 12 or Final Visit

• Change from baseline in body weight.

  Weeks 4, 8 and 12 or Final Visit

• Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment.

  Week 12 or Final Visit

• Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach.

  Week 12 or Final Visit

Study Arms (5)

TAK-379 25 mg QD

EXPERIMENTAL

Drug: TAK-379

TAK-379 100 mg QD

EXPERIMENTAL

Drug: TAK-379

TAK-379 200 mg QD

EXPERIMENTAL

Drug: TAK-379

Pioglitazone 30 mg QD

ACTIVE COMPARATOR

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-379 DRUG

TAK-379 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks

Also known as: Actos

TAK-379 25 mg QD

Pioglitazone DRUG

Pioglitazone 30 mg, tablets, orally, once daily and TAK-379 placebo-matching tablets, orally, once daily for up to 12 weeks

Also known as: Actos, AD4833

Pioglitazone 30 mg QD

Placebo DRUG

TAK-379 placebo-matching tablets, orally, and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy and an 8 week history of diet and exercise.
• Historical diagnosis of type 2 diabetes mellitus on a stable dose of metformin as mono-therapy for at least 3 months prior to screening.
• Glycosylated hemoglobin between 7.5% and 10.0%, inclusive.
• Fasting C-peptide concentration is greater than or equal to 0.8 ng per mL.
• Any other chronic medications which have been stable for at least 4 weeks prior to Screening.
• Body mass index at Screening is greater than or equal to 23 kg/m2 and less than 45 kg/m2.
• Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Compliance with single-blinded study medication during the run-in phase is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.

You may not qualify if:

• Systolic blood pressure is greater than 160 mm Hg, or diastolic pressure is greater than 100 mm Hg at repeat measurements.
• Any history of bladder cancer or has a history of cancer that has been in remission for less than 5 years prior to Screening (a history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed).
• Glycosylated hemoglobin is less than 7.5% and greater than 10.0%.
• Creatine phosphokinase is greater than or equal to 5 times the upper limit of normal at screening.
• Hemoglobin is less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
• Alanine aminotransferase and aspartate aminotransferase are greater than or equal to 2.5 upper limit of normal.
• Total bilirubin is greater than or equal to 1.5 times the upper limit of normal at screening.
• Serum triglyceride concentration is greater than or equal to 400 mg per dL.
• Estimated glomerular filtration rate is less than or equal to 60 mL per min using the Modification of Diet in Renal Disease equation or the Cockroft-Gault equation.
• Abnormal thyroid-stimulating hormone as defined by central laboratory normals.
• Positive test result for hepatitis B surface antigen or hepatitis C antibody.
• Urine albumin to creatinine ratio is greater than or equal to 1000 μg per mg at screening.
• History of microscopic or macroscopic hematuria.
• Two consecutive unexplained positive urinalysis dip-stick and greater than or equal to 3 red blood cells per high-powered field on two consecutive measurements.
• History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (8)

Unknown Facility

Artesia, California, United States

Location

Unknown Facility

Norwalk, California, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Panama City, Florida, United States

Location

Unknown Facility

Cranston, Rhode Island, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

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

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 24, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

US (8)