Clinical Trial Page

Clinical Trial Results:
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus

Summary
EudraCT number
2017-003220-78
Trial protocol
DE  
Global end of trial date
14 Nov 2019

Results information
Results version number
v1(current)
This version publication date
21 May 2020
First version publication date
21 May 2020
Other versions

Trial information

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Trial identification
Sponsor protocol code
I8B-MC-ITSA
Additional study identifiers
ISRCTN number
-
US NCT number
NCT03465878
WHO universal trial number (UTN)
-
Other trial identifiers
Trial Number: 16695
Sponsors
Sponsor organisation name
Eli Lilly and Company
Sponsor organisation address
Lilly Corporate Center, Indianapolis, IN, United States, 46285
Public contact
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
Scientific contact
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
Yes
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
14 Nov 2019
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
14 Nov 2019
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
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.
Protection of trial subjects
This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
Background therapy
-
Evidence for comparator
-
Actual start date of recruitment
26 Mar 2018
Long term follow-up planned
No
Independent data monitoring committee (IDMC) involvement?
No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
Canada: 53
Country: Number of subjects enrolled
Germany: 28
Worldwide total number of subjects
81
EEA total number of subjects
28
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
0
Children (2-11 years)
25
Adolescents (12-17 years)
27
Adults (18-64 years)
29
From 65 to 84 years
0
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
Participants who completed Part A but discontinued before the beginning of Part B were replaced by newly enrolled participants in Part B.

Pre-assignment
Screening details
No Text Available

Period 1
Period 1 title
Period 1
Is this the baseline period?
Yes
Allocation method
Randomised - controlled
Blinding used
Double blind
Roles blinded
Subject, Investigator

Arms
Are arms mutually exclusive
Yes

Arm title
Sequence 1-Part A
Arm description
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Arm title
Sequence 2-Part A
Arm description
Participants received either single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014
Arm type
Active comparator

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Arm title
Sequence 1-Part B
Arm description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Infusion
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Infusion
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Arm title
Sequence 2-Part B
Arm description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014
Arm type
Active comparator

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Infusion
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Infusion
Routes of administration
Subcutaneous use
Dosage and administration details
Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Number of subjects in period 1
Sequence 1-Part A Sequence 2-Part A Sequence 1-Part B Sequence 2-Part B
Started
21
21
20
19
Received at least 1 dose of study drug
21
21
20
17
Participants Moved From Part A to Part B
0 [1]
0 [2]
15 [3]
10 [4]
Children (2-11 Years)
7 [5]
6 [6]
6 [7]
6 [8]
Adolescents (12-17 Years)
7 [9]
7 [10]
7 [11]
6 [12]
Adults (18-64 Years)
7 [13]
8 [14]
7 [15]
7 [16]
Completed
21
20
20
17
Not completed
0
1
0
2
     Physician decision
-
-
-
1
     Consent withdrawn by subject
-
1
-
1
Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
Period 2
Period 2 title
Period 2
Is this the baseline period?
No
Allocation method
Randomised - controlled
Blinding used
Double blind
Roles blinded
Subject, Investigator

Arms
Are arms mutually exclusive
Yes

Arm title
Sequence 1-Part A
Arm description
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Arm title
Sequence 2-Part A
Arm description
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
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Arm title
Sequence 1-Part B
Arm description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Arm title
Sequence 2-Part B
Arm description
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
Arm type
Experimental

Investigational medicinal product name
LY900014
Investigational medicinal product code
Other name
Ultra-Rapid Lispro
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name
Humalog
Investigational medicinal product code
Other name
Insulin Lispro; LY275585
Pharmaceutical forms
Injection
Routes of administration
Subcutaneous use
Dosage and administration details
Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Number of subjects in period 2
Sequence 1-Part A Sequence 2-Part A Sequence 1-Part B Sequence 2-Part B
Started
21
20
20
17
Children (2-11 Years)
7 [17]
6 [18]
6 [19]
6 [20]
Adolescents (12-17 Years)
7 [21]
7 [22]
7 [23]
6 [24]
Adults (18-64 Years)
7 [25]
7 [26]
7 [27]
5 [28]
Completed
21
20
20
17
Notes
[17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[20] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[21] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[22] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[23] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[24] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[25] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[26] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[27] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[28] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.

Baseline characteristics

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Baseline characteristics reporting groups
Reporting group title
Period 1
Reporting group description
-

Reporting group values
Period 1 Total
Number of subjects
81 81
Age categorical
Units: Subjects
    In utero
0 0
    Preterm newborn infants (gestational age < 37 wks)
0 0
    Newborns (0-27 days)
0 0
    Infants and toddlers (28 days-23 months)
0 0
    Children (2-11 years)
25 25
    Adolescents (12-17 years)
27 27
    Adults (18-64 years)
29 29
    From 65-84 years
0 0
    85 years and over
0 0
Gender categorical
Units: Subjects
    Female
41 41
    Male
40 40
Ethnicity (NIH/OMB)
Units: Subjects
    Hispanic or Latino
2 2
    Not Hispanic or Latino
79 79
    Unknown or Not Reported
0 0
Race (NIH/OMB)
Units: Subjects
    American Indian or Alaska Native
0 0
    Asian
4 4
    Native Hawaiian or Other Pacific Islander
0 0
    Black or African American
1 1
    White
71 71
    More than one race
5 5
    Unknown or Not Reported
0 0
Region of Enrollment
Units: Subjects
    Canada
53 53
    Germany
28 28
Subject analysis sets

Subject analysis set title
Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.

Subject analysis set title
Part B
Subject analysis set type
Per protocol
Subject analysis set description
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.

Subject analysis set title
Children-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title
Children-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Adolescents-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title
Adolescents-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Adults-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.

Subject analysis set title
Adults-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Children-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Children-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title
Adolescents-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Adolescents-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title
Adults-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Adults-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis sets values
Part A Part B 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
Number of subjects
42
14
13
13
14
14
14
14
11
11
13
13
12
12
Age categorical
Units: Subjects
    In utero
    Preterm newborn infants (gestational age < 37 wks)
    Newborns (0-27 days)
    Infants and toddlers (28 days-23 months)
    Children (2-11 years)
    Adolescents (12-17 years)
    Adults (18-64 years)
    From 65-84 years
    85 years and over
Age continuous
Units: years
    arithmetic mean (standard deviation)
±
±
±
±
±
±
±
±
±
±
±
±
±
±
Gender categorical
Units: Subjects
    Female
    Male
Ethnicity (NIH/OMB)
Units: Subjects
    Hispanic or Latino
    Not Hispanic or Latino
    Unknown or Not Reported
Race (NIH/OMB)
Units: Subjects
    American Indian or Alaska Native
    Asian
    Native Hawaiian or Other Pacific Islander
    Black or African American
    White
    More than one race
    Unknown or Not Reported
0
Region of Enrollment
Units: Subjects
    Canada
    Germany

End points

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End points reporting groups
Reporting group title
Sequence 1-Part A
Reporting group description
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Reporting group title
Sequence 2-Part A
Reporting group description
Participants received either single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014

Reporting group title
Sequence 1-Part B
Reporting group description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Reporting group title
Sequence 2-Part B
Reporting group description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014
Reporting group title
Sequence 1-Part A
Reporting group description
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Reporting group title
Sequence 2-Part A
Reporting group description
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

Reporting group title
Sequence 1-Part B
Reporting group description
Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Reporting group title
Sequence 2-Part B
Reporting group description
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

Subject analysis set title
Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.

Subject analysis set title
Part B
Subject analysis set type
Per protocol
Subject analysis set description
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.

Subject analysis set title
Children-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title
Children-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Adolescents-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title
Adolescents-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Adults-LY900014-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.

Subject analysis set title
Adults-Humalog-Part A
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title
Children-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Children-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title
Adolescents-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Adolescents-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title
Adults-LY900014-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title
Adults-Humalog-Part B
Subject analysis set type
Per protocol
Subject analysis set description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

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End point title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part
End point description
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data.
End point type
Primary
End point timeframe
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose
End point values
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
Number of subjects analysed
13
13
14
14
14
14
11
11
13
13
11
12
Units: picomols * hour per Liter
    geometric mean (geometric coefficient of variation)
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 title
AUC(0 -7h)
Comparison groups
Children-LY900014-Part A v Children-Humalog-Part A
Number of subjects included in analysis
26
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.9813
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
0.999
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.918
     upper limit
1.09
Statistical analysis title
AUC(0 -7h)
Comparison groups
Adolescents-LY900014-Part A v Adolescents-Humalog-Part A
Number of subjects included in analysis
28
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.1638
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
1.06
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.976
     upper limit
1.15
Statistical analysis title
AUC(0 -7h)
Comparison groups
Adults-LY900014-Part A v Adults-Humalog-Part A
Number of subjects included in analysis
28
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.7623
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
1.01
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.933
     upper limit
1.1
Statistical analysis title
AUC(0 -7h)
Comparison groups
Children-LY900014-Part B v Children-Humalog-Part B
Number of subjects included in analysis
22
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.2952
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
1.04
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.962
     upper limit
1.13
Statistical analysis title
AUC(0 -7h)
Comparison groups
Adolescents-LY900014-Part B v Adolescents-Humalog-Part B
Number of subjects included in analysis
26
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.4052
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
0.97
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.901
     upper limit
1.04
Statistical analysis title
AUC(0 -7h)
Comparison groups
Adults-LY900014-Part B v Adults-Humalog-Part B
Number of subjects included in analysis
23
Analysis specification
Pre-specified
Analysis type
superiority
P-value
= 0.5314
Method
Mixed models analysis
Parameter type
Ratio of geometric least squares means
Point estimate
1.02
Confidence interval
     level
95%
     sides
2-sided
     lower limit
0.948
     upper limit
1.11

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

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End point title
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
End point 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. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable Glucodynamics data.
End point type
Secondary
End point timeframe
-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
End point values
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
Number of subjects analysed
12
12
13
13
14
14
10
10
13
13
12
12
Units: milligrams * hour per deciliter
    arithmetic mean (standard deviation)
384 ± 335
492 ± 270
577 ± 247
651 ± 238
372 ± 179
351 ± 240
602 ± 221
582 ± 254
614 ± 160
614 ± 163
343 ± 194
401 ± 235
No statistical analyses for this end point

Adverse events

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Adverse events information
Timeframe for reporting adverse events
Entire Study
Adverse event reporting additional description
I8B-MC-ITSA
Assessment type
Systematic
Dictionary used for adverse event reporting
Dictionary name
MedDRA
Dictionary version
21.1
Reporting groups
Reporting group title
Children-LY900014-Part A
Reporting group description
-

Reporting group title
Children-Humalog-Part A
Reporting group description
-

Reporting group title
Adolescents-LY900014-Part A
Reporting group description
-

Reporting group title
Adolescents-Humalog-Part A
Reporting group description
-

Reporting group title
Adults-LY900014-Part A
Reporting group description
-

Reporting group title
Adults-Humalog-Part A
Reporting group description
-

Reporting group title
Children-LY900014-Part B
Reporting group description
-

Reporting group title
Children-Humalog-Part B
Reporting group description
-

Reporting group title
Adolescents-LY900014-Part B
Reporting group description
-

Reporting group title
Adolescents-Humalog-Part B
Reporting group description
-

Reporting group title
Adults-LY900014-Part B
Reporting group description
-

Reporting group title
Adults-Humalog-Part B
Reporting group description
-

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
Total subjects affected by serious adverse events
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     number of deaths (all causes)
0
0
0
0
0
0
0
0
0
0
0
0
     number of deaths resulting from adverse events
0
0
0
0
0
0
0
0
0
0
0
0
Injury, poisoning and procedural complications
injury
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-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
Total subjects affected by non serious adverse events
     subjects affected / exposed
4 / 13 (30.77%)
4 / 13 (30.77%)
6 / 14 (42.86%)
3 / 14 (21.43%)
2 / 14 (14.29%)
2 / 15 (13.33%)
6 / 12 (50.00%)
4 / 12 (33.33%)
3 / 13 (23.08%)
1 / 13 (7.69%)
3 / 12 (25.00%)
2 / 12 (16.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lipoma
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
1 / 13 (7.69%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
1
0
0
0
0
0
0
0
0
0
0
Immune system disorders
seasonal allergy
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
1
0
0
0
0
0
0
1
0
0
General disorders and administration site conditions
feeling hot
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
1
0
0
0
0
0
injection site discomfort
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
1 / 13 (7.69%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
0
0
1
0
0
0
injection site erythema
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
2 / 13 (15.38%)
0 / 13 (0.00%)
2 / 14 (14.29%)
1 / 14 (7.14%)
1 / 14 (7.14%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
     occurrences all number
2
0
2
1
1
0
0
0
0
0
1
0
injection site pain
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
1 / 13 (7.69%)
0 / 13 (0.00%)
0 / 14 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
1 / 13 (7.69%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 12 (8.33%)
     occurrences all number
1
0
0
1
0
0
1
0
1
0
1
1
injection site pruritus
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
     occurrences all number
0
0
0
0
0
0
0
0
0
0
0
1
Reproductive system and breast disorders
dysmenorrhoea
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
1 / 15 (6.67%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
1
0
0
0
0
1
0
ovarian cyst ruptured
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
1 / 15 (6.67%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
1
0
0
0
0
0
0
Injury, poisoning and procedural complications
procedural pain
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
1 / 13 (7.69%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
1
0
0
0
0
0
0
0
0
0
0
0
Respiratory, thoracic and mediastinal disorders
epistaxis
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
0
1
0
0
0
0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
0
1
0
0
0
0
headache
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
1 / 15 (6.67%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
1
0
0
0
0
0
0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
1
1
0
0
0
0
nausea
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
1 / 13 (7.69%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
1 / 14 (7.14%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
1
0
1
0
1
0
0
0
0
0
0
0
vomiting
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
1 / 14 (7.14%)
1 / 14 (7.14%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
1
1
0
0
0
0
0
0
0
Renal and urinary disorders
leukocyturia
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
1 / 13 (7.69%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
1
0
0
0
0
0
0
0
0
0
0
Skin and subcutaneous tissue disorders
lipohypertrophy
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
1 / 13 (7.69%)
1 / 14 (7.14%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
1 / 13 (7.69%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
1
1
1
0
0
1
0
1
0
0
0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
1
0
0
0
0
0
0
0
0
0
Endocrine disorders
hypothyroidism
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
1
0
0
0
0
0
0
0
0
0
Metabolism and nutrition disorders
hyperglycaemia
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
1 / 13 (7.69%)
1 / 13 (7.69%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
     occurrences all number
1
1
0
0
0
0
1
1
0
0
0
1
Infections and infestations
acne pustular
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
1
0
0
0
0
0
0
0
0
0
cystitis
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
     occurrences all number
0
0
0
0
0
0
0
0
0
0
0
1
ear infection
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
1
0
0
0
0
0
gastroenteritis
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
0
1
0
0
0
0
groin abscess
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
1
0
0
0
0
0
0
0
0
0
nasopharyngitis
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
1 / 13 (7.69%)
2 / 13 (15.38%)
1 / 14 (7.14%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
1
2
1
0
0
0
0
0
0
0
0
0
upper respiratory tract infection
alternative dictionary used: MedDRA 21.1
     subjects affected / exposed
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 14 (0.00%)
0 / 15 (0.00%)
1 / 12 (8.33%)
1 / 12 (8.33%)
0 / 13 (0.00%)
0 / 13 (0.00%)
0 / 12 (0.00%)
0 / 12 (0.00%)
     occurrences all number
0
0
0
0
0
0
1
1
0
0
0
0

More information

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Substantial protocol amendments (globally)

Were there any global substantial amendments to the protocol? Yes
Date
Amendment
19 Mar 2018
Protocol (b): Total daily insulin dose was updated in inclusion criteria.
17 Apr 2018
Protocol (c): Inpatient Procedures for Part A and B was updated.

Interruptions (globally)

Were there any global interruptions to the trial? No

Limitations and caveats

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported
3