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

NCT01163721 | Completed Phase 2 Results

• 1 other identifier: GS-US-259-0107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; T2DM; Ranolazine; Ranexa; HbA1c

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.

  Baseline to Week 12

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

  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.

  Baseline to Week 12

• Change From Baseline in Fasting Serum Glucose at 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.

  Baseline to Week 12

Study Arms (2)

Ranolazine

EXPERIMENTAL

Participants were randomized to receive ranolazine for 12 weeks.

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Participants were randomized to receive placebo to match ranolazine for 12 weeks.

Drug: Placebo

Interventions

Ranolazine DRUG

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

Also known as: Ranexa®

Ranolazine

Placebo DRUG

Placebo to match ranolazine administered orally twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (9)

AMCR Institute

Escondido, California, 92026, United States

Location

National Research Institute (NRI)

Los Angeles, California, 90057, United States

Location

SeaView Research Inc.

Miami, Florida, 33126, United States

Location

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

Location

Midwest Institute For Clinical Research Inc. (MICR)

Indianapolis, Indiana, 46260, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Rochester Clinical Research (RCR)

Rochester, New York, 14609, United States

Location

Cetero Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 23, 2013
• Results First Posted: September 23, 2013

Record last verified: 2013-07

Locations

US (9)