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Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01472185
First received: November 11, 2011
Last updated: October 15, 2014
Last verified: October 2014
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Ranolazine
Drug: Placebo
Behavioral: Diet
Behavioral: Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at a total of 113 study sites in the United States, South Africa, Europe, and Russia. The first participant was screened on 15 November 2011. The last participant observation occurred on 21 October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
605 participants entered the qualifying period; 465 were randomized, and 464 were randomized and treated (Safety Analysis Set). Of these, 8 were excluded due to major eligibility criteria protocol violation or had baseline but no on-treatment data; thus, 456 were included in the Full Analysis Set.

Reporting Groups
  Description
Placebo

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Ranolazine

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.


Participant Flow:   Overall Study
    Placebo   Ranolazine
STARTED   232   233 
COMPLETED   198   199 
NOT COMPLETED   34   34 
Randomized but Not Treated                0                1 
Adverse Event Other than Hyperglycemia                3                10 
Hyperglycemia                5                2 
Investigator’s Discretion                3                1 
Lost to Follow-up                4                1 
Protocol Violation                5                1 
Subject Noncompliance                8                15 
Subject Withdrew Consent                6                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are reported for the Safety Analysis Set following randomization. The Safety Analysis Set includes randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.

Reporting Groups
  Description
Placebo

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Ranolazine

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Total Total of all reporting groups

Baseline Measures
   Placebo   Ranolazine   Total 
Overall Participants Analyzed 
[Units: Participants]
 232   232   464 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (9.3)   55  (9.5)   56  (9.4) 
Age, Customized 
[Units: Participants]
     
< 65 years   197   199   396 
≥ 65 years   35   33   68 
Gender 
[Units: Participants]
     
Female   113   123   236 
Male   119   109   228 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   31   29   60 
Not Hispanic or Latino   201   202   403 
Unknown or Not Reported   0   1   1 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   10   9   19 
Black or African-American   10   9   19 
White   209   213   422 
Other   2   1   3 
Not Permitted   1   0   1 
Region of Enrollment [1] 
[Units: Participants]
     
Serbia   0   2   2 
United States   62   56   118 
Hungary   12   9   21 
Slovakia   8   13   21 
Poland   7   11   18 
Ukraine   39   36   75 
Romania   10   11   21 
South Africa   11   13   24 
Russian Federation   83   82   165 
[1] All randomized participants were analyzed for region of enrollment (placebo, n = 232; ranolazine, n = 233).
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 32.8  (4.85)   32.8  (4.75)   32.8  (4.80) 
Glycosylated hemoglobin (HbA1c) 
[Units: Percent HbA1c in blood]
Mean (Standard Deviation)
 8.01  (0.727)   8.06  (0.732)   8.04  (0.729) 
Fasting Serum Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 171.5  (34.45)   172.1  (34.32)   171.8  (34.35) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 3.0  (4.00)   3.0  (4.29)   3.0  (4.14) 
Estimated glomerular filtration rate (eGFR) 
[Units: mL/min/1.73m^2]
Mean (Standard Deviation)
 83.3  (18.40)   84.5  (18.80)   83.9  (18.59) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: Baseline; Week 24 ]

2.  Secondary:   Change From Baseline in Fasting Serum Glucose at Week 24   [ Time Frame: Baseline; Week 24 ]

3.  Secondary:   Percentage of Participants With HbA1c < 7% at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24   [ Time Frame: Baseline; Week 24 ]

5.  Secondary:   Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24   [ Time Frame: Baseline; Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01472185     History of Changes
Other Study ID Numbers: GS-US-259-0131
Study First Received: November 11, 2011
Results First Received: October 8, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovakia: Ethics Committee
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
Ukraine: Ethics Committee
Ukraine: Ministry of Health