Trial Outcomes & Findings for A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes (NCT NCT01408888)
NCT ID: NCT01408888
Last Updated: 2014-10-07
Results Overview
Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC \[0-tau\]) during one dosing interval (24 hours) is summarized.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
LY2189265, Sitagliptin + LY2189265
First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).
Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
There was a washout of at least 21 days between treatments.
|
Sitagliptin + LY2189265, LY2189265
First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).
There was a washout of at least 21 days between treatments.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
11
|
|
First Intervention
Received at Least 1 Dose of Drug
|
18
|
11
|
|
First Intervention
COMPLETED
|
18
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
3
|
|
Washout of at Least 21 Days
STARTED
|
18
|
8
|
|
Washout of at Least 21 Days
COMPLETED
|
18
|
8
|
|
Washout of at Least 21 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
18
|
8
|
|
Second Intervention
COMPLETED
|
16
|
8
|
|
Second Intervention
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
LY2189265, Sitagliptin + LY2189265
First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).
Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
There was a washout of at least 21 days between treatments.
|
Sitagliptin + LY2189265, LY2189265
First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).
There was a washout of at least 21 days between treatments.
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
|
Second Intervention
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=29 Participants
Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2Population: Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.
Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC \[0-tau\]) during one dosing interval (24 hours) is summarized.
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=28 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=29 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=26 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin
|
3210 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 34
|
3240 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 36
|
2970 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 54
|
PRIMARY outcome
Timeframe: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2Population: Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=28 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=29 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=27 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin
|
417 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 46
|
374 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
318 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 77
|
SECONDARY outcome
Timeframe: Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2Population: Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=28 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=29 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=27 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin
|
1.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 0.5 to 16.0
|
2.00 hours
Interval 0.5 to 12.0
|
SECONDARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2Population: Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.
Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC \[0-tau\]) during one dosing interval (168 hours) is summarized.
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=26 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=27 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=26 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265
|
6590 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 40
|
8890 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 26
|
13900 nanograms times hour/milliliter(ng*h/mL)
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2Population: Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=26 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=29 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=26 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265
|
52.9 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
68.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
101 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2Population: Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.
Outcome measures
| Measure |
100 mg Sitagliptin (Day 4)
n=26 Participants
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)
n=29 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
|
100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
n=26 Participants
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
|
|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265
|
72.0 hours
Interval 12.0 to 120.0
|
72.0 hours
Interval 48.0 to 144.0
|
59.8 hours
Interval 12.0 to 120.0
|
Adverse Events
LY2189265
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Sitagliptin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sitagliptin + LY2189265
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2189265
n=26 participants at risk
LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1
Time frame: Treatment 1
|
Sitagliptin
n=29 participants at risk
Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.
Time Frame: Day 1 to Day 5 of Treatment 2
|
Sitagliptin + LY2189265
n=29 participants at risk
Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.
Time Frame: Day 5 to end of Treatment 2
|
|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
LY2189265
n=26 participants at risk
LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1
Time frame: Treatment 1
|
Sitagliptin
n=29 participants at risk
Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.
Time Frame: Day 1 to Day 5 of Treatment 2
|
Sitagliptin + LY2189265
n=29 participants at risk
Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.
Time Frame: Day 5 to end of Treatment 2
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Eye disorders
Chalazion
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
2/26 • Number of events 2
|
0.00%
0/29
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
0.00%
0/29
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • Number of events 2
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 2
|
0.00%
0/29
|
13.8%
4/29 • Number of events 6
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Fatigue
|
11.5%
3/26 • Number of events 3
|
3.4%
1/29 • Number of events 1
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Feeling jittery
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Injection site pain
|
7.7%
2/26 • Number of events 2
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Swelling
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.8%
1/26 • Number of events 2
|
0.00%
0/29
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
13.8%
4/29 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.8%
1/26 • Number of events 2
|
3.4%
1/29 • Number of events 1
|
13.8%
4/29 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26
|
0.00%
0/29
|
6.9%
2/29 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26
|
3.4%
1/29 • Number of events 4
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/26
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 4
|
3.4%
1/29 • Number of events 1
|
17.2%
5/29 • Number of events 5
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Nervous system disorders
Somnolence
|
0.00%
0/26
|
6.9%
2/29 • Number of events 3
|
0.00%
0/29
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Psychiatric disorders
Restlessness
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/26
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60