Trial Outcomes & Findings for A Study of LY2608204 in Patients With Type 2 Diabetes (NCT NCT01247363)
NCT ID: NCT01247363
Last Updated: 2018-11-16
Results Overview
Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Day 1 through Day 49
Results posted on
2018-11-16
Participant Flow
Participant milestones
| Measure |
LY2608204
Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY2608204 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
|
Fasting Blood Glucose (FBG)
|
233.5 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 38.61 • n=99 Participants
|
|
Glycated Hemoglobin (HbA1c)
|
10.48 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.89 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 49Population: Participants who were administered study drug.
Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.
Outcome measures
| Measure |
160 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=19 Participants
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=17 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
400 mg LY2608204 Day 28
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Adverse Effects
|
9 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours PostdosePopulation: Participants who were administered study drug.
AUC for Day 1 is AUC from 0 to 24 hours. AUC for all other days is AUC at a dosing interval.
Outcome measures
| Measure |
160 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=19 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
400 mg LY2608204 Day 28
n=17 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC)
|
1090 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 30
|
2780 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 30
|
5450 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 30
|
8650 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 28
|
12100 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours PostdosePopulation: Participants who were administered study drug.
Outcome measures
| Measure |
160 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=19 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
400 mg LY2608204 Day 28
n=17 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|---|
|
Maximum Drug Concentration (Cmax)
|
78.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
175 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
336 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
515 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
690 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours PostdosePopulation: Participants who were administered study drug.
Outcome measures
| Measure |
160 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=19 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
400 mg LY2608204 Day 28
n=17 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|---|
|
Time to Maximum Drug Concentration (Tmax)
|
6.50 hour
Interval 4.0 to 12.0
|
6.50 hour
Interval 2.0 to 12.0
|
6.00 hour
Interval 4.0 to 10.05
|
6.00 hour
Interval 2.0 to 12.0
|
6.00 hour
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: Participants who were administered study drug.
Number of hypoglycemia events with blood glucose concentration \<70 milligram/deciliter (mg/dL).
Outcome measures
| Measure |
160 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 Participants
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=19 Participants
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=17 Participants
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
400 mg LY2608204 Day 28
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|---|
|
Number of Hypoglycemic Events
|
0 events
|
7 events
|
4 events
|
0 events
|
—
|
Adverse Events
160 mg LY2608204
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
240 mg LY2608204
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
320 mg LY2608204
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
400 mg LY2608204
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
160 mg LY2608204
n=20 participants at risk
Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
|
240 mg LY2608204
n=20 participants at risk
Oral capsules of LY2608204 given once daily at dose of 240 mg
|
320 mg LY2608204
n=19 participants at risk
Oral capsules of LY2608204 given once daily at dose of 320 mg
|
400 mg LY2608204
n=17 participants at risk
Oral capsules of LY2608204 given once daily at dose of 400 mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/20
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/20
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/17
|
|
Eye disorders
Vision blurred
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 2
|
0.00%
0/19
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1
|
15.0%
3/20 • Number of events 4
|
0.00%
0/19
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20
|
10.0%
2/20 • Number of events 3
|
21.1%
4/19 • Number of events 4
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
0.00%
0/19
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/19
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Asthenia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
5.3%
1/19 • Number of events 2
|
0.00%
0/17
|
|
Infections and infestations
Laryngitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/19
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/20
|
10.0%
2/20 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/19
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/20
|
15.0%
3/20 • Number of events 7
|
10.5%
2/19 • Number of events 4
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/19
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • Number of events 10
|
20.0%
4/20 • Number of events 5
|
10.5%
2/19 • Number of events 3
|
11.8%
2/17 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
0.00%
0/19
|
0.00%
0/17
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/20
|
0.00%
0/20
|
5.3%
1/19 • Number of events 2
|
0.00%
0/17
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/19
|
5.9%
1/17 • Number of events 1
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/17
|
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