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A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Metformin in Subjects With Type 2 Diabetes Mellitus

NCT01555164•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented history of T2DM
•Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
•Body mass index (BMI) 25 to 45 kg/m\^2, inclusive, at Screening
•HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose
•C-peptide ≥ 0.8 ng/mL at Screening
•Fasting serum glucose (FSG) ≥ 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

Exclusion Criteria

•Type 1 diabetes mellitus
•History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
•History of severe hypoglycemia
•Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
•History of congestive heart failure
•Corrected QT interval (QTc) \> 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
•Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
•Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \> 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) \> 3 x ULN and/or serum total bilirubin \> 2.0 mg/dL
•Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization
•Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days)
+3 more criteria

Locations (146)

Fundamental Research LLC

Gulf Shores, Alabama, United States

KLR Business Group DBA Arkansas Clinical Research

Little Rock, Alaska, United States

Radiant Research, Inc.

Chandler, Arizona, United States

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Clinical Research Advantage

Tempe, Arizona, United States

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

National Research Institute

Los Angeles, California, United States

Ritchken and First MD's

San Diego, California, United States

Clearview Medical Research, LLC

Santa Clarita, California, United States

Metabolic Institute of America

Tarzana, California, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

September 1, 2013

Completion Date

October 1, 2013

Last Updated

September 23, 2014

Enrollment

442

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Ranolazine

DRUG

Placebo to match ranolazine

DRUG

Metformin

DRUG

Placebo to match metformin

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: September 23, 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.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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