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

October 2, 2012
July 25, 2013
September 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01699737 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
Same as current
 
Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: JTT-851
  • Drug: Glimepiride
    Encapsulated Glimepiride tablets
  • Drug: Placebo for Active
  • Drug: Placebo for comparator
  • Experimental: JTT-851 Dose 1
    JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: JTT-851
    • Drug: Placebo for comparator
  • Active Comparator: Glimepiride Dose 1
    Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
    Interventions:
    • Drug: Glimepiride
    • 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
    Interventions:
    • Drug: Placebo for Active
    • Drug: Placebo for comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01699737
AT851-U-12-002
No
Akros Pharma Inc.
Akros Pharma Inc.
Not Provided
Study Chair: Hisashi Kodama, Ph.D. Akros Pharma Inc.
Akros Pharma Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP