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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01699737
First received: October 2, 2012
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: JTT-851
Drug: Glimepiride
Drug: Placebo for Active
Drug: Placebo for comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks


Secondary Outcome Measures:
  • Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.

  • Effect on ancillary efficacy measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.

  • Pharmacokinetics of JTT-851 and its metabolites [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes


Other Outcome Measures:
  • Relationship between dose and response of JTT-851 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To explore the relationship between the JTT-851 dose (exposure) and response


Enrollment: 325
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JTT-851 Dose 1
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851 Drug: Placebo for comparator
Experimental: JTT-851 Dose 2
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851 Drug: Placebo for comparator
Experimental: JTT-851 Dose 3
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851 Drug: Placebo for comparator
Active Comparator: Glimepiride Dose 1
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
Drug: Glimepiride
Encapsulated Glimepiride tablets
Drug: Placebo for Active
Placebo Comparator: Placebo active & 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

Detailed Description:

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699737

  Show 79 Study Locations
Sponsors and Collaborators
Akros Pharma Inc.
Investigators
Study Chair: Hisashi Kodama, Ph.D. Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT01699737     History of Changes
Other Study ID Numbers: AT851-U-12-002
Study First Received: October 2, 2012
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Akros Pharma Inc.:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014