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A New Oral Treatment For Type II Diabetes Mellitus

NCT00111800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2018-03-21

Study results available
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Summary

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DRUG

DEN 2.5 mg

DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DRUG

DEN 7.5 mg

DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DRUG

DEN 15 mg

DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DRUG

DEN 30 mg

DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DRUG

DEN 45 mg

DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-04-28
Primary Completion
2006-07-01
Completion
2006-07-21

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • Germany
  • Greece
  • Latvia
  • Puerto Rico
  • Romania
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00111800 on ClinicalTrials.gov