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Completed

NCT Number: 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

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AMCR Institute, Escondido, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranolazine

Drug

Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily

Other names: Ranexa®

Placebo

Drug

Placebo to match ranolazine administered orally twice daily

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

    Time frame: Baseline to Week 12

    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.

  2. Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal

    Time frame: Baseline to Week 12

    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.

  3. Change From Baseline in Fasting Serum Glucose at Week 12

    Time frame: Baseline to Week 12

    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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2010
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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