Trial Outcomes & Findings for A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus (NCT NCT01029795)
NCT ID: NCT01029795
Last Updated: 2011-12-02
Results Overview
Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
TERMINATED
PHASE2
38 participants
Baseline, 12 weeks
2011-12-02
Participant Flow
Participant milestones
| Measure |
LY2599506
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
22
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
22
|
Reasons for withdrawal
| Measure |
LY2599506
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
|---|---|---|
|
Overall Study
Entry Criteria Not Met
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Sponsor Decision
|
11
|
17
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2599506
n=16 Participants
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
n=22 Participants
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.76 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
59.38 years
STANDARD_DEVIATION 5.86 • n=7 Participants
|
59.54 years
STANDARD_DEVIATION 6.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Duration of Diabetes in Years
|
6.08 year
STANDARD_DEVIATION 5.03 • n=5 Participants
|
7.73 year
STANDARD_DEVIATION 5.64 • n=7 Participants
|
7.03 year
STANDARD_DEVIATION 5.38 • n=5 Participants
|
|
Percentage of Glycosylated Fraction of Hemoglobin A1c
|
7.90 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.75 • n=5 Participants
|
7.78 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.02 • n=7 Participants
|
7.83 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.91 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: The QT interval was not analyzed due to insufficient sample size.
Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: HOMA2 (%B) was not calculated due to insufficient sample size.
HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: HOMA2 (%S) was not calculated due to insufficient sample size.
HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Data were reviewed but not presented due to insufficient sample size.
Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Quality of life data were not analyzed due to insufficient sample size.
Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Quality of life data were not analyzed due to insufficient sample size.
DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Quality of life data were not analyzed due to insufficient sample size.
Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Quality of life data were not analyzed due to insufficient sample size.
Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Quality of life data were not analyzed due to insufficient sample size.
PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from "None of the time," to "All of the time." The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 16 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose \<70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 16 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.
Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.
Outcome measures
| Measure |
LY2599506
n=16 Participants
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
n=22 Participants
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
|---|---|---|
|
Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period
|
18.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12Population: Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.
The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12Population: Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.
The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 16 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose \<70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 16 weeksPopulation: Data were reviewed but are not presented due to the insufficient sample size.
Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.Population: Data were reviewed but are not presented due to insufficient sample size.
Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.Population: Data were reviewed but are not presented due to insufficient sample size.
Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Data were reviewed but are not presented due to insufficient sample size.
Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose\<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks.Population: No participants had data analyzed due to insufficient sample size.
The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Outcome measures
Outcome data not reported
Adverse Events
LY2599506
Glyburide
Serious adverse events
| Measure |
LY2599506
n=16 participants at risk
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
n=22 participants at risk
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
6.2%
1/16 • Number of events 1
|
0.00%
0/22
|
Other adverse events
| Measure |
LY2599506
n=16 participants at risk
Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
|
Glyburide
n=22 participants at risk
Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Infectious mononucleosis
|
6.2%
1/16 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Influenza
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2
|
0.00%
0/22
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60