Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Ranolazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01163721

GS-US-259-0107

Details and patient eligibility

About

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).

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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