Trial Outcomes & Findings for Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM (NCT NCT02526524)
NCT ID: NCT02526524
Last Updated: 2018-04-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
571 participants
Primary outcome timeframe
Baseline and 16 weeks after the first dose of study medication
Results posted on
2018-04-27
Participant Flow
Participant milestones
| Measure |
600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
94
|
95
|
96
|
96
|
96
|
94
|
|
Overall Study
COMPLETED
|
82
|
86
|
70
|
89
|
72
|
73
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
26
|
7
|
24
|
21
|
Reasons for withdrawal
| Measure |
600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
6
|
1
|
9
|
5
|
|
Overall Study
Adverse Event
|
3
|
2
|
4
|
2
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
8
|
1
|
2
|
5
|
|
Overall Study
Protocol Violation
|
3
|
1
|
5
|
3
|
4
|
3
|
|
Overall Study
Loss of Glucose Control
|
0
|
0
|
3
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
Baseline characteristics by cohort
| Measure |
600 mg Met DR qAM
n=94 Participants
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
n=95 Participants
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
n=96 Participants
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
n=96 Participants
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
n=96 Participants
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
n=94 Participants
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
Total
n=571 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
55 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
55 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
55 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
57 years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
57 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
56 years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
269 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
302 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
245 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
326 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
82 Participants
n=8 Participants
|
454 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Body Weight
|
94 kg
STANDARD_DEVIATION 19.9 • n=5 Participants
|
89 kg
STANDARD_DEVIATION 18.5 • n=7 Participants
|
93 kg
STANDARD_DEVIATION 20.9 • n=5 Participants
|
95 kg
STANDARD_DEVIATION 22.2 • n=4 Participants
|
86 kg
STANDARD_DEVIATION 17.1 • n=21 Participants
|
89 kg
STANDARD_DEVIATION 21.3 • n=8 Participants
|
91 kg
STANDARD_DEVIATION 20.2 • n=8 Participants
|
|
Body Mass Index
|
33 kg/m²
STANDARD_DEVIATION 5.1 • n=5 Participants
|
32 kg/m²
STANDARD_DEVIATION 5.5 • n=7 Participants
|
32 kg/m²
STANDARD_DEVIATION 5.9 • n=5 Participants
|
33 kg/m²
STANDARD_DEVIATION 5.8 • n=4 Participants
|
31 kg/m²
STANDARD_DEVIATION 5.1 • n=21 Participants
|
32 kg/m²
STANDARD_DEVIATION 5.4 • n=8 Participants
|
32 kg/m²
STANDARD_DEVIATION 5.5 • n=8 Participants
|
|
HbA1c
|
8.6 %
STANDARD_DEVIATION 0.85 • n=5 Participants
|
8.7 %
STANDARD_DEVIATION 0.82 • n=7 Participants
|
8.7 %
STANDARD_DEVIATION 0.90 • n=5 Participants
|
8.6 %
STANDARD_DEVIATION 0.94 • n=4 Participants
|
8.6 %
STANDARD_DEVIATION 0.87 • n=21 Participants
|
8.6 %
STANDARD_DEVIATION 0.92 • n=8 Participants
|
8.6 %
STANDARD_DEVIATION 0.88 • n=8 Participants
|
|
HbA1c stratum
<8.5%
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
272 Participants
n=8 Participants
|
|
HbA1c stratum
≥8.5%
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
299 Participants
n=8 Participants
|
|
Fasting Plasma Glucose
|
204 mg/dL
STANDARD_DEVIATION 58.1 • n=5 Participants
|
202 mg/dL
STANDARD_DEVIATION 45.3 • n=7 Participants
|
205 mg/dL
STANDARD_DEVIATION 59.0 • n=5 Participants
|
212 mg/dL
STANDARD_DEVIATION 53.5 • n=4 Participants
|
204 mg/dL
STANDARD_DEVIATION 57.3 • n=21 Participants
|
200 mg/dL
STANDARD_DEVIATION 50.3 • n=8 Participants
|
205 mg/dL
STANDARD_DEVIATION 54.0 • n=8 Participants
|
|
Diabetes Duration
|
6.6 years
STANDARD_DEVIATION 5.20 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 8.01 • n=7 Participants
|
7.3 years
STANDARD_DEVIATION 6.25 • n=5 Participants
|
7.6 years
STANDARD_DEVIATION 5.99 • n=4 Participants
|
8.3 years
STANDARD_DEVIATION 6.99 • n=21 Participants
|
8.6 years
STANDARD_DEVIATION 7.13 • n=8 Participants
|
7.9 years
STANDARD_DEVIATION 6.67 • n=8 Participants
|
|
Estimated Glomerular Filtration Rate
|
94.4 mL/min/1.73m²
STANDARD_DEVIATION 19.05 • n=5 Participants
|
94.5 mL/min/1.73m²
STANDARD_DEVIATION 22.83 • n=7 Participants
|
96.2 mL/min/1.73m²
STANDARD_DEVIATION 24.48 • n=5 Participants
|
95.9 mL/min/1.73m²
STANDARD_DEVIATION 22.77 • n=4 Participants
|
96.4 mL/min/1.73m²
STANDARD_DEVIATION 27.42 • n=21 Participants
|
96.2 mL/min/1.73m²
STANDARD_DEVIATION 22.42 • n=8 Participants
|
95.6 mL/min/1.73m²
STANDARD_DEVIATION 23.22 • n=8 Participants
|
|
Estimated Glomerular Filtration Rate Subgroup
<90 mL/min/1.73m²
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
251 Participants
n=8 Participants
|
|
Estimated Glomerular Filtration Rate Subgroup
≥90 mL/min/1.73m²
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
320 Participants
n=8 Participants
|
|
Prior Metformin Use
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
277 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeks after the first dose of study medicationPopulation: Modified Intent-to-Treat: Subjects who took ≥1 dose of randomized study medication and had ≥1 post-Baseline value for HbA1c collected ≤1 week after discontinuing study medication and prior to administration of any new anti-diabetic medication with timing and/or dosage that may have reasonably influenced any subsequent glycemic data collected.
Outcome measures
| Measure |
600 mg Met DR qAM
n=88 Participants
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
n=93 Participants
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
n=88 Participants
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
n=94 Participants
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
n=90 Participants
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
n=89 Participants
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
|---|---|---|---|---|---|---|
|
Change in HbA1c (%) at 16 Weeks
|
-0.33 % glycated haemoglobin
Standard Error 0.129
|
-0.40 % glycated haemoglobin
Standard Error 0.123
|
-0.49 % glycated haemoglobin
Standard Error 0.129
|
-0.62 % glycated haemoglobin
Standard Error 0.124
|
-0.06 % glycated haemoglobin
Standard Error 0.131
|
-1.10 % glycated haemoglobin
Standard Error 0.129
|
Adverse Events
600 mg Met DR qAM
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
900 mg Met DR qAM
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
1200 mg Met DR qAM
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
1500 mg Met DR qAM
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 1 deaths
2000 mg Met IR
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
600 mg Met DR qAM
n=94 participants at risk
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
n=95 participants at risk
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
n=96 participants at risk
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
n=96 participants at risk
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
n=96 participants at risk
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
n=94 participants at risk
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.1%
1/94 • 16 Weeks
|
|
General disorders
Death
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
1.1%
1/94 • 16 Weeks
|
0.00%
0/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
Other adverse events
| Measure |
600 mg Met DR qAM
n=94 participants at risk
600 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
900 mg Met DR qAM
n=95 participants at risk
900 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1200 mg Met DR qAM
n=96 participants at risk
1200 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
1500 mg Met DR qAM
n=96 participants at risk
1500 mg metformin delayed-release once daily in the morning
Met DR: metformin delayed-release tablets
|
Placebo
n=96 participants at risk
placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)
Placebo
|
2000 mg Met IR
n=94 participants at risk
1000 mg metformin immediate-release twice daily
Met IR: metformin immediate-release tablets
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
7/94 • 16 Weeks
|
7.4%
7/95 • 16 Weeks
|
11.5%
11/96 • 16 Weeks
|
11.5%
11/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
13.8%
13/94 • 16 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.5%
8/94 • 16 Weeks
|
10.5%
10/95 • 16 Weeks
|
7.3%
7/96 • 16 Weeks
|
8.3%
8/96 • 16 Weeks
|
10.4%
10/96 • 16 Weeks
|
5.3%
5/94 • 16 Weeks
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/94 • 16 Weeks
|
3.2%
3/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
3.1%
3/96 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
9.6%
9/94 • 16 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/94 • 16 Weeks
|
5.3%
5/95 • 16 Weeks
|
1.0%
1/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
2.1%
2/96 • 16 Weeks
|
2.1%
2/94 • 16 Weeks
|
|
Metabolism and nutrition disorders
Worsening Type 2 diabetes mellitus
|
3.2%
3/94 • 16 Weeks
|
1.1%
1/95 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
0.00%
0/96 • 16 Weeks
|
5.2%
5/96 • 16 Weeks
|
0.00%
0/94 • 16 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the Study may be published by INSTITUTE, however the publication shall not disclose any SPONSOR Confidential Information, the INSTITUTE shall send the SPONSOR a copy of any such proposed publication 90 days prior to submission for publication, the INSTITUTE, on request of the SPONSOR, shall delete any SPONSOR Confidential Information in the proposed publication, and the INSTITUTE shall, on the SPONSOR's request, delay submission while the SPONSOR files applications for patents.
- Publication restrictions are in place
Restriction type: OTHER