Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

NCT01699737 | Completed Phase 2

• 1 other identifier: AT851-U-12-002
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 79

Brief Summary

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851

  To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks

  12 weeks

Secondary Outcomes (3)

• Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo

  12 weeks

• Effect on ancillary efficacy measures

  12 weeks

• Pharmacokinetics of JTT-851 and its metabolites

  12 weeks

Other Outcomes (1)

• Relationship between dose and response of JTT-851

  12 weeks

Study Arms (5)

JTT-851 Dose 1

EXPERIMENTAL

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Drug: JTT-851; Drug: Placebo for comparator

JTT-851 Dose 2

EXPERIMENTAL

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Drug: JTT-851; Drug: Placebo for comparator

JTT-851 Dose 3

EXPERIMENTAL

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Drug: JTT-851; Drug: Placebo for comparator

Glimepiride Dose 1

ACTIVE COMPARATOR

Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks

Drug: Glimepiride; Drug: Placebo for Active

Placebo active & Placebo comparator

PLACEBO COMPARATOR

Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks

Drug: Placebo for Active; Drug: Placebo for comparator

Interventions

JTT-851 DRUG

JTT-851 Dose 1; JTT-851 Dose 2; JTT-851 Dose 3

Glimepiride DRUG

Encapsulated Glimepiride tablets

Glimepiride Dose 1

Placebo for Active DRUG

Glimepiride Dose 1; Placebo active & Placebo comparator

Placebo for comparator DRUG

JTT-851 Dose 1; JTT-851 Dose 2; JTT-851 Dose 3; Placebo active & Placebo comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with type 2 diabetes, 18-70 years of age at Visit 1
• Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
• Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
• Body mass index (BMI) ≥ 23.0 kg/m\^2 and ≤ 45.0 kg/m\^2 at Visit 1

You may not qualify if:

• Females who are pregnant or breast-feeding
• Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
• Acute coronary syndrome or uncontrolled hypertension
• Does not meet all diet or previous/concomitant medication restriction criteria

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (79)

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Huntsville, Alabama, United States

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Montgomery, Alabama, United States

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Muscle Shoals, Alabama, United States

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Glendale, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Artesia, California, United States

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Beverly Hills, California, United States

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Buena Park, California, United States

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Chino, California, United States

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Garden Grove, California, United States

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Lincoln, California, United States

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Lomita, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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North Hollywood, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Cooper City, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Kissimee, Florida, United States

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Miami, Florida, United States

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Miramar, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Nampa, Idaho, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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New Orleans, Louisiana, United States

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Oxon Hill, Maryland, United States

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Olive Branch, Mississippi, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Mine Hill, New Jersey, United States

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Glen Falls, New York, United States

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Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Marion, Ohio, United States

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Munroe Falls, Ohio, United States

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Wadsworth, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Lansdale, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Tomball, Texas, United States

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Murray, Utah, United States

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Orem, Utah, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Suffolk, Virginia, United States

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Madison, Wisconsin, United States

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

glimepiride; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hisashi Kodama, Ph.D.

  Akros Pharma Inc.

  STUDY CHAIR

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: October 2, 2012
• First Posted: October 4, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (79)