Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Exploratory Study to Access the Metabolic Effects of Ranolazine When Added to Ongoing Non-Insulin Antidiabetic Therapy in Subjects With Type 2 Diabetes Mellitus|
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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.
- Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Fasting Serum Glucose at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Participants were randomized to receive ranolazine for 12 weeks.
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
Other Name: Ranexa®
Placebo Comparator: Placebo
Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Placebo to match ranolazine administered orally twice daily
|United States, California|
|Escondido, California, United States, 92026|
|National Research Institute (NRI)|
|Los Angeles, California, United States, 90057|
|United States, Florida|
|SeaView Research Inc.|
|Miami, Florida, United States, 33126|
|Orlando Clinical Research Center (OCRC)|
|Orlando, Florida, United States, 32809|
|United States, Indiana|
|Midwest Institute For Clinical Research Inc. (MICR)|
|Indianapolis, Indiana, United States, 46260|
|United States, Kansas|
|Vince and Associates Clinical Research|
|Overland Park, Kansas, United States, 66212|
|United States, Kentucky|
|L-MARC Research Center|
|Louisville, Kentucky, United States, 40213|
|United States, New York|
|Rochester Clinical Research (RCR)|
|Rochester, New York, United States, 14609|
|United States, Texas|
|San Antonio, Texas, United States, 78229|