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
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 April 15, 2014