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A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

NCT01555164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2014-09-23

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.

Conditions

Interventions

DRUG

Ranolazine

Ranolazine tablet(s) administered orally

DRUG

Placebo to match ranolazine

Placebo to match ranolazine for the duration of the study

DRUG

Metformin

Metformin tablet(s) administered orally once daily

DRUG

Placebo to match metformin

Placebo to match metformin for the duration of the study

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

Principal Investigators

  • Patrick Yue, MD · Gilead Sciences

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
2012-06-30
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • India
  • Israel
  • Mexico
  • Poland
  • Russia
  • 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 NCT01555164 on ClinicalTrials.gov