Trial · NCT01494987
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
NCT01494987, Phase 3, Completed, Gilead Sciences; results first posted 2014-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus. Trials, record NCT01494987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
- NCT number
- NCT01494987
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 431 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Ranolazine, Placebo, Glimepiride, Diet, Exercise
- First posted
- 2011-12-19
- Last updated
- 2014-11-18
- Results first posted
- 2014-09-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline; Week 24 | The average (mean) change from baseline in HbA1c at Week 24 was analyzed. |
| Secondary | Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 | Baseline; Week 24 | The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed. Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received. |
| Secondary | Change From Baseline in Fasting Serum Glucose at Week 24 | Baseline; Week 24 | The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed. |
| Secondary | Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24 | Baseline; Week 24 | The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed. | percent of HbA1c in blood | MEAN |
| SECONDARY | Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 | Baseline; Week 24 | Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Serum Glucose at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24 | Baseline; Week 24 | Participants in the MMTT Full Analysis Set with available data were analyzed. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Placebo+Glimepiride | HbA1c at Week 24 | 8.08 | Standard Deviation 1.070 | percent of HbA1c in blood |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Ranolazine+Glimepiride | HbA1c at Week 24 | 7.58 | Standard Deviation 1.089 | percent of HbA1c in blood |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Placebo+Glimepiride | Change from baseline in HbA1c at Week 24 | 0.03 | Standard Deviation 0.949 | percent of HbA1c in blood |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Ranolazine+Glimepiride | Change from baseline in HbA1c at Week 24 | -0.47 | Standard Deviation 0.971 | percent of HbA1c in blood |
| Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 | Placebo+Glimepiride | -2 | Standard Deviation 42.6 | mg/dL | |
| Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 | Ranolazine+Glimepiride | 1 | Standard Deviation 44.7 | mg/dL | |
| Change From Baseline in Fasting Serum Glucose at Week 24 | Placebo+Glimepiride | 8 | Standard Deviation 40.7 | mg/dL | |
| Change From Baseline in Fasting Serum Glucose at Week 24 | Ranolazine+Glimepiride | 2 | Standard Deviation 45.3 | mg/dL | |
| Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24 | Placebo+Glimepiride | 4 | Standard Deviation 58.0 | mg/dL | |
| Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24 | Ranolazine+Glimepiride | 1 | Standard Deviation 59.6 | mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo+Glimepiride | 216 | |
| Overall Study | STARTED | Ranolazine+Glimepiride | 215 | |
| Overall Study | COMPLETED | Placebo+Glimepiride | 188 | |
| Overall Study | COMPLETED | Ranolazine+Glimepiride | 187 | |
| Overall Study | NOT COMPLETED | Placebo+Glimepiride | 28 | |
| Overall Study | NOT COMPLETED | Ranolazine+Glimepiride | 28 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperglycemia | Metabolism and nutrition disorders | Placebo+Glimepiride | 32 | 216 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Ranolazine+Glimepiride | 21 | 215 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo+Glimepiride | 10 | 216 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Ranolazine+Glimepiride | 13 | 215 | |
| other | Nausea | Gastrointestinal disorders | Placebo+Glimepiride | 7 | 216 | |
| other | Nausea | Gastrointestinal disorders | Ranolazine+Glimepiride | 11 | 215 | |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo+Glimepiride | 1 | 216 | |
| serious | Acute myocardial infarction | Cardiac disorders | Ranolazine+Glimepiride | 0 | 215 | |
| serious | Myocardial ischaemia | Cardiac disorders | Placebo+Glimepiride | 0 | 216 | |
| serious | Myocardial ischaemia | Cardiac disorders | Ranolazine+Glimepiride | 1 | 215 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo+Glimepiride | ||
| Total, all-cause mortality | Ranolazine+Glimepiride | ||
| Total, other adverse events | Placebo+Glimepiride | 46 | 216 |
| Total, other adverse events | Ranolazine+Glimepiride | 42 | 215 |
| Total, serious adverse events | Placebo+Glimepiride | 4 | 216 |
| Total, serious adverse events | Ranolazine+Glimepiride | 4 | 215 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo+Glimepiride vs Ranolazine+Glimepiride: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01494987
GET https://conductscience.org/api/trials/v1/NCT01494987/events?page=2