A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03465878
Collaborator
(none)
56
2
4
19.6
28
1.4
Study Details
Study Description
Brief Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.
There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
Actual Study Start Date
:
Mar 26, 2018
Actual Primary Completion Date
:
Nov 14, 2019
Actual Study Completion Date
:
Nov 14, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY900014-Part A Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. |
Drug: LY900014
Administered via SC injection
Other Names:
|
| Active Comparator: Humalog (Insulin Lispro)-Part A Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog. |
Drug: Insulin Lispro
Administered via SC injection
Other Names:
|
| Experimental: LY900014-Part B Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump. |
Drug: LY900014
Administered via SC injection
Other Names:
|
| Active Comparator: Humalog (Insulin Lispro)-Part B Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. |
Drug: Insulin Lispro
Administered via SC injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part [Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose]
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Secondary Outcome Measures
- Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part [-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose]
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
-
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)
Exclusion Criteria:
-
Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
-
More than one episode of severe hypoglycaemia in the last 6 months
-
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
-
Have obvious clinical signs or symptoms of liver disease
-
Have a history of renal impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LMC Endocrinology Centres Ltd. | Toronto | Ontario | Canada | M4G 3E8 |
| 2 | Kinderkrankenhaus auf der Bult | Hannover | Niedersachsen | Germany | 30173 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03465878
Other Study ID Numbers:
- 16695
- I8B-MC-ITSA
- 2017-003220-78
First Posted:
Mar 14, 2018
Last Update Posted:
Jun 18, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants (pts) who completed Part A but discontinued before the beginning of Part B were replaced by newly enrolled participants in Part B. |
|---|---|
| Pre-assignment Detail | Two period crossover study, with a minimum of 22 days washout period between each period. |
| Arm/Group Title | Sequence 1-Part A | Sequence 2-Part A | Sequence 1-Part B | Sequence 2-Part B |
|---|---|---|---|---|
| Arm/Group Description | Participants received either single 0.2 units per kilogram (U/kg) of body weight subcutaneous (SC) bolus injection of 100 units per milliliter (U/mL) LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog | Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014 | Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog delivered using the continuous subcutaneous insulin infusion (CSII) pump. Period 1: LY900014 Period 2: Humalog | Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014 |
| Period Title: Period 1-Part A First Intervention Day 1 | ||||
| STARTED | 21 | 21 | 0 | 0 |
| Received at Least 1 Dose of Study Drug | 21 | 21 | 0 | 0 |
| Children (2-11 Years) | 7 | 6 | 0 | 0 |
| Adolescents (12-17 Years) | 7 | 7 | 0 | 0 |
| Adults (18-64 Years) | 7 | 8 | 0 | 0 |
| COMPLETED | 21 | 20 | 0 | 0 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
| Period Title: Period 1-Part A First Intervention Day 1 | ||||
| STARTED | 21 | 20 | 0 | 0 |
| Children (2-11 Years) | 7 | 6 | 0 | 0 |
| Adolescents (12-17 Years) | 7 | 7 | 0 | 0 |
| Adults (18-64 Years) | 7 | 7 | 0 | 0 |
| COMPLETED | 21 | 20 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Period 1-Part A First Intervention Day 1 | ||||
| STARTED | 0 | 0 | 20 | 19 |
| Received at Least 1 Dose of Study Drug | 0 | 0 | 20 | 17 |
| Children (2-11 Years) | 0 | 0 | 6 | 6 |
| Adolescents (12-17 Years) | 0 | 0 | 7 | 6 |
| Adults (18-64 Years) | 0 | 0 | 7 | 5 |
| COMPLETED | 0 | 0 | 20 | 17 |
| NOT COMPLETED | 0 | 0 | 0 | 2 |
| Period Title: Period 1-Part A First Intervention Day 1 | ||||
| STARTED | 0 | 0 | 20 | 17 |
| Children (2-11 Years) | 0 | 0 | 6 | 6 |
| Adolescents (12-17 Years) | 0 | 0 | 7 | 6 |
| Adults (18-64 Years) | 0 | 0 | 7 | 5 |
| COMPLETED | 0 | 0 | 20 | 17 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A | Part B | Total |
|---|---|---|---|
| Arm/Group Description | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog. | Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump. | Total of all reporting groups |
| Overall Participants | 42 | 14 | 56 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
20.5
(15.1)
|
23.2
(11.1)
|
21.2
(14.2)
|
| Age, Customized (Count of Participants) | |||
| Children (2-11 Years) |
13
31%
|
3
21.4%
|
16
28.6%
|
| Adolescents (12-17 years) |
14
33.3%
|
2
14.3%
|
16
28.6%
|
| Adults (18-64 years) |
15
35.7%
|
9
64.3%
|
24
42.9%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
47.6%
|
8
57.1%
|
28
50%
|
| Male |
22
52.4%
|
6
42.9%
|
28
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
4.8%
|
0
0%
|
2
3.6%
|
| Not Hispanic or Latino |
40
95.2%
|
14
100%
|
54
96.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
2.4%
|
2
14.3%
|
3
5.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
2.4%
|
0
0%
|
1
1.8%
|
| White |
37
88.1%
|
11
78.6%
|
48
85.7%
|
| More than one race |
3
7.1%
|
1
7.1%
|
4
7.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Canada |
28
66.7%
|
10
71.4%
|
38
67.9%
|
| Germany |
14
33.3%
|
4
28.6%
|
18
32.1%
|
Outcome Measures
| Title | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part |
|---|---|
| Description | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part. |
| Time Frame | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. |
| Measure Participants | 13 | 13 | 14 | 14 | 14 | 14 | 11 | 11 | 13 | 13 | 12 | 12 |
| Geometric Mean (Geometric Coefficient of Variation) [Picomoles*hour/Liter (pmol*h/L)] |
755
(15)
|
754
(17)
|
962
(17)
|
908
(21)
|
987
(20)
|
975
(21)
|
743
(17)
|
714
(17)
|
842
(20)
|
866
(16)
|
1100
(35)
|
1070
(35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Children-LY900014-Part A, Children-Humalog-Part A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9813 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 0.999 | |
| Confidence Interval |
(2-Sided) 95% 0.918 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Adolescents-LY900014-Part A, Adolescents-Humalog-Part A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1638 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.976 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Adults-LY900014-Part A, Adults-Humalog-Part A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7623 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.933 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Children-LY900014-Part B, Children-Humalog-Part B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2952 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.962 to 1.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Adolescents-LY900014-Part B, Adolescents-Humalog-Part B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4052 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 0.970 | |
| Confidence Interval |
(2-Sided) 95% 0.901 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Adults-LY900014-Part B, Adults-Humalog-Part B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5314 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.948 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part |
|---|---|
| Description | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part. |
| Time Frame | -30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable Glucodynamics data. |
| Arm/Group Title | Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. |
| Measure Participants | 12 | 12 | 13 | 13 | 14 | 14 | 10 | 10 | 13 | 13 | 12 | 12 |
| Mean (Standard Deviation) [milligrams*hour per deciliter (mg*h/dL)] |
384
(335)
|
492
(270)
|
577
(247)
|
651
(238)
|
372
(179)
|
351
(240)
|
602
(221)
|
582
(254)
|
614
(160)
|
614
(163)
|
343
(194)
|
401
(235)
|
Adverse Events
| Time Frame | From Baseline to Study Completion (Up to 20 Months) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. | |||||||||||||||||||||||
| Arm/Group Title | Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B | ||||||||||||
| Arm/Group Description | Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014. | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump. | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/13 (0%) | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) | 0/15 (0%) | 0/12 (0%) | 0/12 (0%) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/12 (0%) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/14 (0%) | 0/14 (0%) | 0/15 (0%) | 0/12 (0%) | 0/12 (0%) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/12 (0%) | ||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Injury | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| Children-LY900014-Part A | Children-Humalog-Part A | Adolescents-LY900014-Part A | Adolescents-Humalog-Part A | Adults-LY900014-Part A | Adults-Humalog-Part A | Children-LY900014-Part B | Children-Humalog-Part B | Adolescents-LY900014-Part B | Adolescents-Humalog-Part B | Adults-LY900014-Part B | Adults-Humalog-Part B | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/13 (30.8%) | 4/13 (30.8%) | 6/14 (42.9%) | 3/14 (21.4%) | 2/14 (14.3%) | 2/15 (13.3%) | 6/12 (50%) | 4/12 (33.3%) | 3/13 (23.1%) | 1/13 (7.7%) | 3/12 (25%) | 2/12 (16.7%) | ||||||||||||
| Endocrine disorders | ||||||||||||||||||||||||
| Hypothyroidism | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Abdominal pain | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Nausea | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Vomiting | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| General disorders | ||||||||||||||||||||||||
| Feeling hot | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Injection site discomfort | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Injection site erythema | 2/13 (15.4%) | 2 | 0/13 (0%) | 0 | 2/14 (14.3%) | 2 | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Injection site pain | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| Injection site pruritus | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Immune system disorders | ||||||||||||||||||||||||
| Seasonal allergy | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||||
| Acne pustular | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Cystitis | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Ear infection | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Gastroenteritis | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Groin abscess | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Nasopharyngitis | 1/13 (7.7%) | 1 | 2/13 (15.4%) | 2 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Upper respiratory tract infection | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Procedural pain | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||||
| Hyperglycaemia | 1/13 (7.7%) | 1 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Arthralgia | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||
| Lipoma | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||
| Dizziness | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Headache | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/15 (6.7%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||||
| Leukocyturia | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||||||
| Dysmenorrhoea | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/15 (6.7%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Ovarian cyst ruptured | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/15 (6.7%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Epistaxis | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Lipohypertrophy | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/15 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
| ClinicalTrials.gov@lilly.com |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03465878
Other Study ID Numbers:
- 16695
- I8B-MC-ITSA
- 2017-003220-78
First Posted:
Mar 14, 2018
Last Update Posted:
Jun 18, 2020
Last Verified:
Dec 1, 2019