A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01555164
First received: March 13, 2012
Last updated: January 17, 2014
Last verified: January 2014

March 13, 2012
January 17, 2014
June 2012
September 2013   (final data collection date for primary outcome measure)
Change from baseline in Hemoglobin A1c [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01555164 on ClinicalTrials.gov Archive Site
  • Change from baseline in incremental change of 2-hour postprandial serum glucose [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The incremental change of 2-hour postprandial serum glucose (PPG) is defined as the difference between the 2-hour PPG and the fasting serum glucose (FSG).
  • Change from baseline in FSG or change from baseline in 2-hour PPG [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Postprandial serum glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Metformin in Subjects With Type 2 Diabetes Mellitus

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in subjects with type 2 diabetes mellitus who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise. The study has been designed to determine the effect of ranolazine on glycemic control and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Ranolazine
    Subjects will receive one tablet of ranolazine 500 mg twice daily followed by two tablets of ranolazine 500 mg twice daily, in addition to metformin, for the duration of the study.
    Other Name: Ranexa
  • Drug: Placebo
    Subjects will receive one tablet of matching placebo twice daily followed by two tablets of matching placebo twice daily, in addition to metformin, for the duration of the study.
  • Experimental: Ranolazine
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented history of T2DM
  • Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
  • Body mass index (BMI) 25 to 45 kg/m^2, inclusive, at Screening
  • HbA1c 7% to 10%, inclusive, at Screening and at the end of Period 1
  • C-peptide ≥ 0.8 ng/mL at Screening
  • FSG ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of Period 1

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
  • History of severe hypoglycemia
  • Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
  • History of congestive heart failure
  • QTc interval > 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
  • Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x ULN and/or serum total bilirubin > 2.0 mg/dL
  • Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to the start of Period 2
  • Treatment with chronic insulin within 24 weeks prior to screening (except for one temporary period of daily insulin injections no longer than 7 days)
  • Treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to Period 2 Day 1
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to Period 2 Day 1
  • Treatment with simvastatin or lovastatin at a dose > 20 mg or > 40 mg daily, respectively, within 14 days prior to Period 2 Day 1
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Hungary,   India,   Israel,   Mexico,   Poland,   Russian Federation,   South Africa,   Ukraine
 
NCT01555164
GS-US-259-0147, 2012-001259-37
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP