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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163721
• Other study ID #: GS-US-259-0107
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2010
• Last updated: July 19, 2013
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: July 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Ranolazine
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
• Placebo
Placebo to match ranolazine administered orally twice daily

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California
United States	Midwest Institute For Clinical Research Inc. (MICR)	Indianapolis	Indiana
United States	National Research Institute (NRI)	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	SeaView Research Inc.	Miami	Florida
United States	Orlando Clinical Research Center (OCRC)	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Rochester Clinical Research (RCR)	Rochester	New York
United States	Cetero Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	Yes