Trial Outcomes & Findings for Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus (NCT NCT01472185)
NCT ID: NCT01472185
Last Updated: 2014-10-24
Results Overview
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2014-10-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
233
|
|
Overall Study
COMPLETED
|
198
|
199
|
|
Overall Study
NOT COMPLETED
|
34
|
34
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
|
Overall Study
Adverse Event Other than Hyperglycemia
|
3
|
10
|
|
Overall Study
Hyperglycemia
|
5
|
2
|
|
Overall Study
Investigator's Discretion
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Subject Noncompliance
|
8
|
15
|
|
Overall Study
Subject Withdrew Consent
|
6
|
3
|
Baseline Characteristics
Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=232 Participants
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
n=232 Participants
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
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
55 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
56 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Customized
< 65 years
|
197 participants
n=5 Participants
|
199 participants
n=7 Participants
|
396 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 participants
n=5 Participants
|
213 participants
n=7 Participants
|
422 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
56 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
83 participants
n=5 Participants
|
82 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Body Mass Index
|
32.8 kg/m^2
STANDARD_DEVIATION 4.85 • n=5 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 4.75 • n=7 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 4.80 • n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.01 percent HbA1c in blood
STANDARD_DEVIATION 0.727 • n=5 Participants
|
8.06 percent HbA1c in blood
STANDARD_DEVIATION 0.732 • n=7 Participants
|
8.04 percent HbA1c in blood
STANDARD_DEVIATION 0.729 • n=5 Participants
|
|
Fasting Serum Glucose
|
171.5 mg/dL
STANDARD_DEVIATION 34.45 • n=5 Participants
|
172.1 mg/dL
STANDARD_DEVIATION 34.32 • n=7 Participants
|
171.8 mg/dL
STANDARD_DEVIATION 34.35 • n=5 Participants
|
|
Duration of Diabetes
|
3.0 years
STANDARD_DEVIATION 4.00 • n=5 Participants
|
3.0 years
STANDARD_DEVIATION 4.29 • n=7 Participants
|
3.0 years
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
83.3 mL/min/1.73m^2
STANDARD_DEVIATION 18.40 • n=5 Participants
|
84.5 mL/min/1.73m^2
STANDARD_DEVIATION 18.80 • n=7 Participants
|
83.9 mL/min/1.73m^2
STANDARD_DEVIATION 18.59 • 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 subjects with major eligibility violations and analyzed based on the 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
n=195 Participants
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
n=199 Participants
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.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Change from baseline in HbA1c at Week 24
|
-0.27 percent of HbA1c in blood
Standard Deviation 1.027
|
-0.80 percent of HbA1c in blood
Standard Deviation 1.020
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
HbA1c at Week 24
|
7.70 percent of HbA1c in blood
Standard Deviation 1.183
|
7.26 percent of HbA1c in blood
Standard Deviation 1.101
|
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
n=191 Participants
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
n=197 Participants
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.
|
|---|---|---|
|
Change From Baseline in Fasting Serum Glucose at Week 24
|
1 mg/dL
Standard Deviation 42.2
|
-7 mg/dL
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set with Baseline HbA1c ≥ 7% and available data were analyzed.
Outcome measures
| Measure |
Placebo
n=195 Participants
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
n=199 Participants
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.
|
|---|---|---|
|
Percentage of Participants With HbA1c < 7% at Week 24
|
25.6 percentage of participants
|
41.2 percentage of participants
|
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 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 time \[T\] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received.
Outcome measures
| Measure |
Placebo
n=178 Participants
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
n=185 Participants
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.
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
|
2 mg/dL
Standard Deviation 65.1
|
-19 mg/dL
Standard Deviation 53.8
|
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.
Outcome measures
| Measure |
Placebo
n=173 Participants
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
n=180 Participants
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.
|
|---|---|---|
|
Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24
|
-1 mg/dL
Standard Deviation 47.7
|
-12 mg/dL
Standard Deviation 37.9
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 31 other events
Deaths: 0 deaths
Ranolazine
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=232 participants at risk
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
n=232 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Cardiac disorders
Sinoatrial block
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage iv
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.43%
1/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
0.00%
0/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
Other adverse events
| Measure |
Placebo
n=232 participants at risk
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
n=232 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.9%
23/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
7.8%
18/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
|
Nervous system disorders
Headache
|
4.3%
10/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
5.2%
12/232 • Up to 24 Weeks plus 30 days
Safety Analysis Set: randomized participants who received at least one dose of study treatment, analyzed based on actual treatment received.
|
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