This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial). 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
Placebo to match ranolazine administered orally twice daily
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
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Time frame: Baseline to Week 12
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal
2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Time frame: Baseline to Week 12
Change From Baseline in Fasting Serum Glucose at Week 12
Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Time frame: Baseline to Week 12
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