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Trial Outcomes & Findings for A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants (NCT NCT03555305)

NCT ID: NCT03555305

Last Updated: 2020-11-24

Results Overview

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

58 participants

Primary outcome timeframe

-0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Results posted on

2020-11-24

Participant Flow

Two period crossover study, with a minimum of 7 days washout period between each period.

Participant milestones

Participant milestones
Measure
Sequence 1
Period 1: Participants received 0.5 units per kilogram (U/kg) of Insulin glargine subcutaneously. Period 2: Participants received 0.5 U/Kg of Lantus subcutaneously.
Sequence 2
Period 1: Participants received 0.5 U/Kg of Lantus subcutaneously. Period 2: Participants received 0.5 U/Kg of Insulin glargine subcutaneously.
Period 1
STARTED
29
29
Period 1
Received at Least 1 Dose of Study Drug
29
29
Period 1
COMPLETED
29
27
Period 1
NOT COMPLETED
0
2
Period 2
STARTED
29
27
Period 2
COMPLETED
29
27
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Sequence 1
Period 1: Participants received 0.5 units per kilogram (U/kg) of Insulin glargine subcutaneously. Period 2: Participants received 0.5 U/Kg of Lantus subcutaneously.
Sequence 2
Period 1: Participants received 0.5 U/Kg of Lantus subcutaneously. Period 2: Participants received 0.5 U/Kg of Insulin glargine subcutaneously.
Period 1
Physician Decision
0
1
Period 1
Adverse Event
0
1

Baseline Characteristics

A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=58 Participants
Participants received 0.5 U/Kg of Insulin glargine and Lantus subcutaneously as per dosing schedule.
Age, Continuous
24.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male
Female
32 Participants
n=5 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
58 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
China
58 Participants
n=5 Participants

PRIMARY outcome

Timeframe: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.

Outcome measures

Outcome measures
Measure
0.5 U/kg Insulin Glargine
n=56 Participants
Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
0.5 U/kg Lantus
n=58 Participants
Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus
124 picomole per liter (pmol/L)
Geometric Coefficient of Variation 31
129 picomole per liter (pmol/L)
Geometric Coefficient of Variation 33

PRIMARY outcome

Timeframe: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC\[0-24\]) of Insulin glargine and Lantus.

Outcome measures

Outcome measures
Measure
0.5 U/kg Insulin Glargine
n=56 Participants
Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
0.5 U/kg Lantus
n=58 Participants
Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus
2170 picomole*hour per liter (pmol*hr/L)
Geometric Coefficient of Variation 28
2310 picomole*hour per liter (pmol*hr/L)
Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: 30 minutes predose through 24 hours postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable Gtot data.

Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

Outcome measures

Outcome measures
Measure
0.5 U/kg Insulin Glargine
n=56 Participants
Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
0.5 U/kg Lantus
n=58 Participants
Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
2390 milligrams/kilogram (mg/kg)
Geometric Coefficient of Variation 43
2680 milligrams/kilogram (mg/kg)
Geometric Coefficient of Variation 40

SECONDARY outcome

Timeframe: 30 minutes predose through 24 hours postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable Rmax data.

Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

Outcome measures

Outcome measures
Measure
0.5 U/kg Insulin Glargine
n=56 Participants
Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
0.5 U/kg Lantus
n=58 Participants
Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
PD: Maximum Glucose Infusion Rate (Rmax)
2.72 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 37
2.99 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 36

Adverse Events

0.5 U/kg Insulin Glargine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

0.5 U/kg Lantus

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60