Trial Outcomes & Findings for Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus (NCT NCT01494987)
NCT ID: NCT01494987
Last Updated: 2014-11-18
Results Overview
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
431 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2014-11-18
Participant Flow
Participants were enrolled (during the Qualifying Period) at a total of 103 study sites in Asia, Europe, South Africa, and the United States. The first participant was screened on 12 January 2012. The last participant observation occurred on 28 August 2013.
595 participants entered the qualifying period (355 required and completed the glimepiride stabilization period); 431 were randomized and treated (Safety Analysis Set). Of these, 14 were excluded due to major eligibility criteria protocol violation or had no baseline or ontreatment data; thus, 417 were included in the Full Analysis Set.
Participant milestones
| Measure |
Placebo+Glimepiride
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
215
|
|
Overall Study
COMPLETED
|
188
|
187
|
|
Overall Study
NOT COMPLETED
|
28
|
28
|
Reasons for withdrawal
| Measure |
Placebo+Glimepiride
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Hyperglycemia
|
6
|
4
|
|
Overall Study
Investigator's Discretion
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Subject Non-Compliance
|
9
|
10
|
|
Overall Study
Subject Withdrew Consent
|
2
|
3
|
Baseline Characteristics
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo+Glimepiride
n=216 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=215 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Duration of Diabetes
|
7.0 years
STANDARD_DEVIATION 5.07 • n=5 Participants
|
7.1 years
STANDARD_DEVIATION 4.92 • n=7 Participants
|
7.0 years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
83.2 mL/min/1.73m^2
STANDARD_DEVIATION 18.77 • n=5 Participants
|
81.2 mL/min/1.73m^2
STANDARD_DEVIATION 20.85 • n=7 Participants
|
82.2 mL/min/1.73m^2
STANDARD_DEVIATION 19.84 • n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
59 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
59 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
198 participants
n=5 Participants
|
204 participants
n=7 Participants
|
402 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
99 participants
n=5 Participants
|
104 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Body Mass Index
|
32.8 kg/m^2
STANDARD_DEVIATION 4.35 • n=5 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 3.88 • n=7 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 4.13 • n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.10 percent HbA1c in blood
STANDARD_DEVIATION 0.746 • n=5 Participants
|
8.07 percent HbA1c in blood
STANDARD_DEVIATION 0.776 • n=7 Participants
|
8.08 percent HbA1c in blood
STANDARD_DEVIATION 0.760 • n=5 Participants
|
|
Fasting Serum Glucose
|
177.2 mg/dL
STANDARD_DEVIATION 34.27 • n=5 Participants
|
177.4 mg/dL
STANDARD_DEVIATION 37.03 • n=7 Participants
|
177.3 mg/dL
STANDARD_DEVIATION 35.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: 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.
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
Outcome measures
| Measure |
Placebo+Glimepiride
n=184 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=188 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
HbA1c at Week 24
|
8.08 percent of HbA1c in blood
Standard Deviation 1.070
|
7.58 percent of HbA1c in blood
Standard Deviation 1.089
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Change from baseline in HbA1c at Week 24
|
0.03 percent of HbA1c in blood
Standard Deviation 0.949
|
-0.47 percent of HbA1c in blood
Standard Deviation 0.971
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Placebo+Glimepiride
n=169 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=168 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24
|
-2 mg/dL
Standard Deviation 42.6
|
1 mg/dL
Standard Deviation 44.7
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.
Outcome measures
| Measure |
Placebo+Glimepiride
n=181 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=183 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Change From Baseline in Fasting Serum Glucose at Week 24
|
8 mg/dL
Standard Deviation 40.7
|
2 mg/dL
Standard Deviation 45.3
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the MMTT Full Analysis Set with available data were analyzed.
The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.
Outcome measures
| Measure |
Placebo+Glimepiride
n=175 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=172 Participants
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
|
4 mg/dL
Standard Deviation 58.0
|
1 mg/dL
Standard Deviation 59.6
|
Adverse Events
Placebo+Glimepiride
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Ranolazine+Glimepiride
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+Glimepiride
n=216 participants at risk
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=215 participants at risk
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
1/216 • Up to 24 weeks plus 30 days
|
0.00%
0/215 • Up to 24 weeks plus 30 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/216 • Up to 24 weeks plus 30 days
|
0.47%
1/215 • Up to 24 weeks plus 30 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.46%
1/216 • Up to 24 weeks plus 30 days
|
0.00%
0/215 • Up to 24 weeks plus 30 days
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/216 • Up to 24 weeks plus 30 days
|
0.47%
1/215 • Up to 24 weeks plus 30 days
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/216 • Up to 24 weeks plus 30 days
|
0.47%
1/215 • Up to 24 weeks plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/216 • Up to 24 weeks plus 30 days
|
0.47%
1/215 • Up to 24 weeks plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/216 • Up to 24 weeks plus 30 days
|
0.47%
1/215 • Up to 24 weeks plus 30 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
1/216 • Up to 24 weeks plus 30 days
|
0.00%
0/215 • Up to 24 weeks plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
1/216 • Up to 24 weeks plus 30 days
|
0.00%
0/215 • Up to 24 weeks plus 30 days
|
Other adverse events
| Measure |
Placebo+Glimepiride
n=216 participants at risk
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen.
|
Ranolazine+Glimepiride
n=215 participants at risk
Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.8%
32/216 • Up to 24 weeks plus 30 days
|
9.8%
21/215 • Up to 24 weeks plus 30 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.6%
10/216 • Up to 24 weeks plus 30 days
|
6.0%
13/215 • Up to 24 weeks plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
3.2%
7/216 • Up to 24 weeks plus 30 days
|
5.1%
11/215 • Up to 24 weeks plus 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER