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Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone

NCT00995345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2014-06-26

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.

Conditions

Interventions

DRUG

KRP-104

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • ActivX Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Diane J Plotkin, PhD · ActivX Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Argentina
  • Czechia
  • Guatemala
  • Poland
  • Russia
  • South Africa

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995345 on ClinicalTrials.gov