Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily; Placebo to match ranolazine administered orally twice daily
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; T2DM; Ranolazine; Ranexa; HbA1c

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet
             and exercise

          -  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:

          -  Type 1 Diabetes Mellitus (T1DM)

          -  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