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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01163721
First received: July 14, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Ranolazine
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine
Participants were randomized to receive ranolazine for 12 weeks.
Drug: Ranolazine
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.
Drug: Placebo
Placebo to match ranolazine administered orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163721

Locations
United States, California
AMCR Institute
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
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01163721     History of Changes
Other Study ID Numbers: GS-US-259-0107
Study First Received: July 14, 2010
Results First Received: July 19, 2013
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Type 2 diabetes mellitus
T2DM
Ranolazine
Ranexa
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Ranolazine
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014