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NCT Number: NCT01699737

Safety and Efficacy Study 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTT-851

Drug

Glimepiride

Drug

Encapsulated Glimepiride tablets

Placebo for Active

Drug

Placebo for comparator

Drug

Primary outcomes

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

    Time frame: 12 weeks

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

Secondary outcomes

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

    Time frame: 12 weeks

    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.

  2. Effect on ancillary efficacy measures

    Time frame: 12 weeks

    To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.

  3. Pharmacokinetics of JTT-851 and its metabolites

    Time frame: 12 weeks

    To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes

Other outcomes

  1. Relationship between dose and response of JTT-851

    Time frame: 12 weeks

    To explore the relationship between the JTT-851 dose (exposure) and response

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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