MedTrace Logo

A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

NCT00631007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2010-09-13

Study results available
· View outcomes & findings →

Summary

This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.

Conditions

Interventions

DRUG

INT131 besylate

Once-daily, oral

DRUG

Pioglitazone HCl

Once-daily, oral

DRUG

Placebo

Once-daily, oral

Sponsors & Collaborators

  • InteKrin Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Orloff, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

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 NCT00631007 on ClinicalTrials.gov