Clinical trial NCT01163721: Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
T2DM
Ranolazine
Ranexa
HbA1c
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal
timeFrame: Baseline to Week 12
measure: Change From Baseline in Fasting Serum Glucose at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Los Angeles
country: United States
facility: National Research Institute (NRI)
state: California
city: Miami
country: United States
facility: SeaView Research Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRC)
state: Florida
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research Inc. (MICR)
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Rochester
country: United States
facility: Rochester Clinical Research (RCR)
state: New York
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
References: