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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Experimental | Participants were randomized to receive ranolazine for 12 weeks. |
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| Placebo | Placebo Comparator | Participants were randomized to receive placebo to match ranolazine for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States | ||
| National Research Institute (NRI) |
The Safety Analysis Set (n = 80) includes participants who were randomized in the study and received at least one dose of study drug. The Full Analysis Set (n = 79) includes participants who were randomized in the study and received at least one dose of study drug, and had at least one post-baseline efficacy measurement.
Participants with type 2 diabetes mellitus (T2DM) were enrolled in a total of 9 study sites in the United States. The first participant was screened on 22 June 2010. The last participant observation was on 15 November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Participants were randomized to receive ranolazine for 12 weeks. |
| FG001 | Placebo | Participants were randomized to receive placebo to match ranolazine for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo to match ranolazine administered orally twice daily |
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| Los Angeles |
| California |
| 90057 |
| United States |
| SeaView Research Inc. | Miami | Florida | 33126 | United States |
| Orlando Clinical Research Center (OCRC) | Orlando | Florida | 32809 | United States |
| Midwest Institute For Clinical Research Inc. (MICR) | Indianapolis | Indiana | 46260 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Rochester Clinical Research (RCR) | Rochester | New York | 14609 | United States |
| Cetero Research | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Participants were randomized to receive ranolazine for 12 weeks. |
| BG001 | Placebo | Participants were randomized to receive placebo to match ranolazine for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percent HbA1c in blood |
| |||||||||||||||
| 2-hour Postprandial Glucose | 2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a meal. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Fasting Serum Glucose | Fasting serum glucose was measured following an overnight fast. | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent of HbA1c in blood | Baseline to Week 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline to Week 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline to Week 12 |
|
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Baseline through Week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine | Participants were randomized to receive ranolazine for 12 weeks. | 0 | 39 | 12 | 39 | ||
| EG001 | Placebo | Participants were randomized to receive placebo to match ranolazine for 12 weeks. | 1 | 41 | 15 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Other |
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| Superiority or Other |
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