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Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

NCT01472185•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent
•Males and females, 18 to 75 years old, inclusive
•Documented history of T2DM
•Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days (TZDs for at least 24 weeks) prior to screening
•Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at screening
•HbA1c 7% - 10%, inclusive at screening and at the end of the Qualifying Period (Day 14 +2 days)
•Fasting serum glucose (FSG) of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at screening and at the end of the Qualifying Period (Day 14 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 125 mg/dL (6.9 mmol/L) and \< 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.
•Fasting serum C-peptide ≥ 0.8 ng/mL at screening
•Able and willing to comply with all study procedures during the course of the study
•Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception methods from screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
+1 more criteria

Exclusion Criteria

•History of or current diagnosis of type 1 diabetes mellitus
•History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
•History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to screening or ≥ 2 episodes within 6 months prior to screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior
•Clinically significant complications of diabetes that, in the judgment of the investigator, would make the subject unsuitable to participate in this study
•History of any clinically significant cardiovascular or cerebrovascular event (eg, myocardial infarction \[MI\], acute coronary syndrome \[ACS\], recent coronary revascularization \[including coronary artery bypass graft procedures or percutaneous coronary intervention\], transient ischemic attack or ischemic stroke) ≤ 3 months prior to screening
•Inadequately controlled or unstable hypertension as defined by systolic blood pressure (SBP) \> 160 mmHg or diastolic blood pressure (DBP) \> 100 mmHg at screening and randomization
•Prolonged QTc interval \> 500 msec by ECG at screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
•History of bariatric surgery at any time in the past or any other surgery \< 2 months before screening, or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the Medical Monitor.
•Any other hospitalization in the 14 days prior to screening or planned hospitalization at any time during the study
•Significant weight change (± 5%) \< 2 months prior to screening or on a weight-loss program and is not in the maintenance phase at screening
+20 more criteria

Locations (159)

Thunderbird Internal Medicine/Clinical Research Advantage

Glendale, Arizona, United States

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

Eclipse Clinical Research

Tucson, Arizona, United States

North Central Arkansas Medical Associates

Mountain Home, Arkansas, United States

Paul W. Davis, MD, Private Practice

Pine Bluff, Arkansas, United States

Southland Clinical Research Center, Inc.

Fountain Valley, California, United States

Global Research Management

Glendale, California, United States

National Research Institute

Los Angeles, California, United States

Spectrum Clinical Research Institute, Inc

Moreno Valley, California, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

October 24, 2014

Enrollment

465

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Ranolazine

DRUG

Placebo

DRUG

Diet

BEHAVIORAL

Exercise

BEHAVIORAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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