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Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

NCT01472185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2014-10-24

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones \[TZDs\] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

Conditions

Interventions

DRUG

Ranolazine

Ranolazine tablets administered orally twice daily.

DRUG

Placebo

Placebo to match ranolazine administered orally twice daily.

BEHAVIORAL

Diet

Participants are instructed to continue the diet regimen prescribed by their physician.

BEHAVIORAL

Exercise

Participants are instructed to continue the exercise regimen prescribed by their physician.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Czechia
  • Hungary
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01472185 on ClinicalTrials.gov