Trial Outcomes & Findings for A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI (NCT NCT02370537)
NCT ID: NCT02370537
Last Updated: 2017-01-20
Results Overview
For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
490 participants
Primary outcome timeframe
7 days after enrollment.
Results posted on
2017-01-20
Participant Flow
First patient enrolled: 7 April 2015. Last patient completed Part B: 17 November 2015. This study was performed in 23 centres across 6 countries in Europe.
A total of 490 patients were screened and of these, 315 patients met all inclusion and none of the exclusion criteria and completed the first part of the study. 51 patients were randomised to treatment in the second part of the study.
Participant milestones
| Measure |
Low FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Intermediate FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|
|
Part A (Open-label Recruitment)
STARTED
|
16
|
16
|
283
|
|
Part A (Open-label Recruitment)
COMPLETED
|
16
|
15
|
282
|
|
Part A (Open-label Recruitment)
NOT COMPLETED
|
0
|
1
|
1
|
|
Part B
STARTED
|
16
|
15
|
282
|
|
Part B
Eligible for Randomisation
|
15
|
13
|
23
|
|
Part B
Period 1 Sequence AB
|
8
|
6
|
11
|
|
Part B
Period 1 Sequence BA
|
7
|
7
|
12
|
|
Part B
Period 2 Sequence AB
|
8
|
5
|
11
|
|
Part B
Period 2 Sequence BA
|
7
|
7
|
12
|
|
Part B
COMPLETED
|
15
|
12
|
23
|
|
Part B
NOT COMPLETED
|
1
|
3
|
259
|
Reasons for withdrawal
| Measure |
Low FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Intermediate FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA® and OMACOR®)
Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|
|
Part A (Open-label Recruitment)
Withdrawal by Subject
|
0
|
1
|
0
|
|
Part A (Open-label Recruitment)
Adverse Event
|
0
|
0
|
1
|
|
Part B
Not randomised to receive treatment
|
1
|
2
|
259
|
|
Part B
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
Baseline characteristics by cohort
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=16 Participants
Patients had low levels (\<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=16 Participants
Patients had intermediate levels (≥100 to \<200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
|
Normal FEC (EPANOVA® and OMACOR®)
n=283 Participants
Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
From 18 - 64 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Age, Customized
From 65 - 84 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Age, Customized
Over 85 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days after enrollment.Population: The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.
For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=16 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=278 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part A: Serum TG Level.
|
2.07 millimole per litre (mmol/L)
Standard Deviation 0.63
|
1.68 millimole per litre (mmol/L)
Standard Deviation 0.57
|
2.00 millimole per litre (mmol/L)
Standard Deviation 1.16
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.
Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=14 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=21 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.
|
2170 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 65.2
|
1650 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 31.3
|
2000 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 82.8
|
946 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 96.0
|
2070 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 36.1
|
1260 hours*mcg per millilitre (h*mcg/mL)
Geometric Coefficient of Variation 126
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.
Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=14 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=21 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.
|
801 h*mcg/mL
Geometric Coefficient of Variation 55.7
|
1040 h*mcg/mL
Geometric Coefficient of Variation 47.1
|
719 h*mcg/mL
Geometric Coefficient of Variation 85.0
|
567 h*mcg/mL
Geometric Coefficient of Variation 70.7
|
625 h*mcg/mL
Geometric Coefficient of Variation 90.2
|
810 h*mcg/mL
Geometric Coefficient of Variation 105
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.
Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=14 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=21 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
|
9700 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 57.7
|
8780 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 32.9
|
8990 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 72.4
|
5130 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 80.6
|
8890 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 43.8
|
6690 h*nanomole/mL (h*nmol/mL)
Geometric Coefficient of Variation 112
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations.
Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=23 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.
|
137 mcg/mL
Geometric Coefficient of Variation 70.5
|
71.5 mcg/mL
Geometric Coefficient of Variation 64.0
|
116 mcg/mL
Geometric Coefficient of Variation 53.3
|
53.9 mcg/mL
Geometric Coefficient of Variation 70.1
|
131 mcg/mL
Geometric Coefficient of Variation 36.2
|
69.3 mcg/mL
Geometric Coefficient of Variation 76.2
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.
Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=23 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.
|
59.0 mcg/mL
Geometric Coefficient of Variation 58.6
|
60.5 mcg/mL
Geometric Coefficient of Variation 47.3
|
56.0 mcg/mL
Geometric Coefficient of Variation 40.6
|
51.0 mcg/mL
Geometric Coefficient of Variation 52.0
|
53.8 mcg/mL
Geometric Coefficient of Variation 41.8
|
59.7 mcg/mL
Geometric Coefficient of Variation 53.9
|
PRIMARY outcome
Timeframe: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.Population: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.
Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Outcome measures
| Measure |
Low FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels \<100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (EPANOVA® and OMACOR®)
n=15 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to \<200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Normal FEC (EPANOVA® and OMACOR®)
n=13 Participants
Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
|
Intermediate FEC (OMACOR®)
n=12 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to \<200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (EPANOVA®)
n=22 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
Normal FEC (OMACOR®)
n=23 Participants
In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
|
|---|---|---|---|---|---|---|
|
Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
|
622 nmol/mL
Geometric Coefficient of Variation 69.7
|
421 nmol/mL
Geometric Coefficient of Variation 54.0
|
553 nmol/mL
Geometric Coefficient of Variation 47.0
|
328 nmol/mL
Geometric Coefficient of Variation 57.2
|
592 nmol/mL
Geometric Coefficient of Variation 36.6
|
413 nmol/mL
Geometric Coefficient of Variation 61.7
|
Adverse Events
Low FEC (EPANOVA®)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low FEC (OMACOR®)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intermediate FEC (EPANOVA®)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermediate FEC (OMACOR®)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal FEC (EPANOVA®)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Normal FEC (OMACOR®)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low FEC (EPANOVA®)
n=15 participants at risk
Patients had low levels (\<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Low FEC (OMACOR®)
n=15 participants at risk
Patients had low levels (\<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
Intermediate FEC (EPANOVA®)
n=13 participants at risk
Patients had intermediate levels (≥100 to \<200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Intermediate FEC (OMACOR®)
n=12 participants at risk
Patients had intermediate levels (≥100 to \<200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
Normal FEC (EPANOVA®)
n=23 participants at risk
Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Normal FEC (OMACOR®)
n=23 participants at risk
Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
Other adverse events
| Measure |
Low FEC (EPANOVA®)
n=15 participants at risk
Patients had low levels (\<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Low FEC (OMACOR®)
n=15 participants at risk
Patients had low levels (\<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
Intermediate FEC (EPANOVA®)
n=13 participants at risk
Patients had intermediate levels (≥100 to \<200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Intermediate FEC (OMACOR®)
n=12 participants at risk
Patients had intermediate levels (≥100 to \<200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
Normal FEC (EPANOVA®)
n=23 participants at risk
Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
|
Normal FEC (OMACOR®)
n=23 participants at risk
Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
4.3%
1/23 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
4.3%
1/23 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
4.3%
1/23 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
4.3%
1/23 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
4.3%
1/23 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
General disorders
Fatigue
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
8.7%
2/23 • Number of events 2 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
|
Injury, poisoning and procedural complications
Traumatic Ulcer
|
0.00%
0/15 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
6.7%
1/15 • Number of events 1 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/13 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/12 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
0.00%
0/23 • All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.
Regular investigator assessment at study sites. Population used was the Safety Analysis Set which included all patients who received at least 1 dose of study treatment in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each Principal Investigator has signed a Confidential Disclosure Agreement which does not allow them to disclose any study related information for 10 years unless it is publically available.
- Publication restrictions are in place
Restriction type: OTHER