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Completed

NCT Number: NCT00929539

Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

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Key information

Conditions

Type II 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

Beroun, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have type 2 diabetes;
  • Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;
  • Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion criteria

  • Females who are pregnant or breast-feeding
  • Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
  • Acute coronary syndrome or uncontrolled hypertension;
  • Does not meet medication restriction criteria, as described in the protocol.

Treatment and study plan

JTT-130

Drug

Tablets

JTT-130 Placebo

Drug

Tablets

Primary outcomes

  1. Change in glycosylated hemoglobin (HbA1c) levels

    Time frame: End of Study

Secondary outcomes

  1. Safety and tolerability data

    Time frame: End of Study

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2009
Registry last updated
Feb 4, 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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