Randomized, Double-blind, Crossover, Pharmacokinetic (PK)... | NCT01275131

NCT01275131

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage 1: Insulin aspart first, then insulin aspart-rHuPH20	Active Comparator	Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4. After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.	Drug: Insulin aspart Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
Stage 1: Insulin aspart-rHuPH20 first, then insulin aspart	Active Comparator	Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4. After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.	Drug: Insulin aspart Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
Stage 3: Insulin aspart first, then insulin aspart + rHuPH20	Active Comparator	Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp. After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin aspart	Drug		Stage 1: Insulin aspart first, then insulin aspart-rHuPH20 Stage 1: Insulin aspart-rHuPH20 first, then insulin aspart Stage 3: Insulin aspart + rHuPH20 first, then insulin aspart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early Insulin Exposure (%AUC[0-60]), Stage 1	Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.	10 minutes predose up to 60 minutes postdose
Early Exposure to Insulin (%AUC[0-60]), Stage 3	Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.](streamdown:incomplete-link)	10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10

Secondary Outcomes

Measure	Description	Time Frame
Maximum Glucose Infusion Rate (GIRmax), Stage 1	Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.	0 up to 360 minutes postdose on Day 2/6 and Day 4/8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for greater than or equal to 12 months. Non-smoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests.
Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m^2), inclusive.
Glycosylated hemoglobin A1c (HbA1c) ≤10 % based on local laboratory results.
Fasting C-peptide <0.6 nanograms per milliliter (ng/mL).
Current treatment with insulin <90 units per day (U/d).
Routine use of continuous subcutaneous insulin infusion (CSII) as the primary route of insulin administration.
Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol.

Exclusion Criteria:

Known or suspected allergy to any component of any of the study drugs in this trial.
Previous enrollment in this trial (Exception: participants in Stage 1 are permitted to participate in Stage 2).
Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. Participants taking maintenance doses of blood thinners (eg, Coumadin or heparin) will be excluded.
Use of any long-acting insulin injection within 72 hours of Stage 1 or Stage 3.
Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.
Current addiction to alcohol or substances of abuse as determined by the Investigator.
Blood donation or phlebotomy (>500 milliliters [mL]) within the previous 8 weeks of Screening. This applies both to new participants and to participants who have participated in Stage 1 and who wish to continue in Stage 2.
Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, or barrier methods).
Symptomatic gastroparesis.
Receipt of any investigational drug within 4 weeks of Stage 1 or Stage 2.

Contacts/Locations Module

Name	Affiliation	Role
Linda Morrow, MD	Profil Institute for Clinical Research, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Profil Institute for Clinical Research		Chula Vista	California	91911	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20	Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4. After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Stage 3: Insulin aspart first, then insulin aspart + rHuPH20

All participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20	Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4. After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.
BG001	Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart	Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4. After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.
BG002	Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20	Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp. After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp.
BG003	Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart	Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp . After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00011 BG0019 BG00213 BG00312 BG00445

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00031.3± 6.39 BG00144.6± 9.00 BG00235.5± 9.50 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00011 BG0019 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Early Insulin Exposure (%AUC[0-60]), Stage 1

Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.

Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.

Posted

Mean

Standard Deviation

Percentage of AUC(0-360)

10 minutes predose up to 60 minutes postdose

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2

Units	Counts
Participants	OG00016 OG00116

Title

Denominators

Categories

Stage 1, Day 2/6

Title	Measurements
	OG00020.99± 6.37 OG00134.94± 9.48

Stage 1, Day 4/8

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Comparison at Stage 1, Day 2/6	Mixed Models Analysis	A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.	0.0009		Least Squares Mean Difference	13.95			2-Sided	90	7.37	20.54				No	Superiority or Other

Secondary

Maximum Glucose Infusion Rate (GIRmax), Stage 1

Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable GIRmax data.

Posted

Mean

Standard Deviation

Milligrams/kilogram/minute

0 up to 360 minutes postdose on Day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.

Primary

Early Exposure to Insulin (%AUC[0-60]), Stage 3

Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.](streamdown:incomplete-link)

Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.

Posted

Mean

Standard Deviation

Percentage of AUC(0-360)

10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Maximum Glucose Infusion Rate (GIRmax), Stage 3

Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable GIRmax data.

Posted

Mean

Standard Deviation

Milligrams/kilogram/minute

0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1

Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable tGIRmax data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on Day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.

Secondary

Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3

Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable tGIRmax data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1

Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.

Secondary

Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3

Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Time to 50% Total Glucose Infused (50%Gtot), Stage 1

Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on Day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.

Secondary

Time to 50% Total Glucose Infused (50%Gtot), Stage 3

Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.

Posted

Mean

Standard Deviation

Minutes

0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1

Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.

Posted

Mean

Standard Deviation

Picomoles*minutes/liter

30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.

Secondary

Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3

Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.

Posted

Mean

Standard Deviation

Picomoles*minutes/liter

30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Secondary

Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1

Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.

Posted

Mean

Standard Deviation

Ratio

10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8

ID	Title	Description
OG000	Stage 1: Insulin Aspart Alone	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
OG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.

Secondary

Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3

Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.

Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.

Posted

Mean

Standard Deviation

ratio

10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10

ID	Title	Description
OG000	Stage 3: Insulin Aspart Alone	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
OG001	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Stage 1: Insulin Aspart	Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.	20	16	20
EG001	Stage 1: Insulin Aspart-rHuPH20	Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.	18	13	18
EG002	Stage 3: Insulin Aspart	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.	23	14	23
EG003	Stage 3: Insulin Aspart + rHuPH20	Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.	22	12	22

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site erythema	General disorders	MedDRA (14.0)	Systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected18 at risk EG0020 events0 affected23 at risk EG0030 events0 affected22 at risk
Infusion site pain	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected18 at risk EG0021 events1 affected23 at risk EG003
Injection site haemorrhage	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected18 at risk EG0020 events0 affected23 at risk EG003
Injection site pruritus	General disorders	MedDRA (14.0)	Systematic Assessment	EG0004 events2 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Asthenia	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Fatigue	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site extravasation	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site haemorrhage	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site oedema	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Injection site inflammation	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Injection site oedema	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Headache	Nervous system disorders	MedDRA (14.0)	Systematic Assessment	EG0007 events7 affected20 at risk EG0013 events3 affected18 at risk EG0025 events4 affected23 at risk EG003
Dizziness	Nervous system disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment	EG0003 events3 affected20 at risk EG0013 events3 affected18 at risk EG0020 events0 affected23 at risk EG003
Incision site erythema	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Oedema peripheral	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Vessel puncture site swelling	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Injection site pain	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Infusion site haematoma	General disorders	MedDRA (14.0)	Systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site irritation	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site pruritus	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Infusion site thrombosis	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Vessel puncture site pain	General disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Tremor	Nervous system disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion site infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Fungal infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Hordeolum	Infections and infestations	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Infusion site cellulitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Vaginal infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0022 events2 affected23 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0021 events1 affected23 at risk EG003
Burns first degree	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected18 at risk EG0020 events0 affected23 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected18 at risk EG0020 events0 affected23 at risk EG003

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D061267	Insulin Aspart

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Units	Counts
Participants	OG00016 OG00116