Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
NCT ID: NCT01163721
Last Updated: 2013-09-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2010-06-30
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or \> 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia.
Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ranolazine
Participants were randomized to receive ranolazine for 12 weeks.
Ranolazine
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
Placebo
Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Placebo
Placebo to match ranolazine administered orally twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranolazine
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
Placebo
Placebo to match ranolazine administered orally twice daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) ≥ 25 kg/m\^2 and ≤ 40 kg/m\^2
* HbA1c 7 - 11%
* Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
* Female of child-bearing potential must have agreed to use effective methods of contraception
* Ability to understand and willing to sign written informed consent
Exclusion Criteria
* T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
* History of ketoacidosis or ketosis-prone diabetes
* Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
* History of a severe episode of hypoglycemia
* Change in non-insulin antidiabetic therapy in addition to diet and exercise \< 2 months prior to screening
* Any clinically significant cardiovascular event \< 2 months prior to screening
* Clinically significant, inadequately controlled or unstable hypertension
* Hospitalization \< 2 months prior to screening
* Major surgery \< 3 months prior to screening
* Weight loss medication (prescription or non-prescription) \< 2 months prior to screening
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AMCR Institute
Escondido, California, United States
National Research Institute (NRI)
Los Angeles, California, United States
SeaView Research Inc.
Miami, Florida, United States
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States
Midwest Institute For Clinical Research Inc. (MICR)
Indianapolis, Indiana, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Rochester Clinical Research (RCR)
Rochester, New York, United States
Cetero Research
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-259-0107
Identifier Type: -
Identifier Source: org_study_id