Trial Outcomes & Findings for A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus (NCT NCT01600950)

NCT ID: NCT01600950

Last Updated: 2014-10-07

Results Overview

Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Periods 1 and 2: Baseline up to 42 hours postdose

Results posted on

2014-10-07

Participant Flow

This was a randomized, 2-period, 2-sequence, crossover study.

Participant milestones

Participant milestones
Measure	LY2963016/Lantus A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days. A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2.	Lantus/LY2963016 A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days. A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2.
Period 1 STARTED	10	10
Period 1 COMPLETED	10	10
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	10	10
Period 2 COMPLETED	10	10
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
Age, Continuous	41.5 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	20 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 Germany	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.

Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.

Outcome measures

Outcome measures
Measure	LY2963016 n=20 Participants A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.	Lantus n=20 Participants A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
Pharmacodynamics: Duration of Action of LY2963016 and Lantus	37.13 hours (hr) Interval 2.8 to 40.5	40.00 hours (hr) Interval 2.0 to 41.5

SECONDARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.

Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) \[5.6 millimoles/Liter (mmol/L)\] 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.

Outcome measures

Outcome measures
Measure	LY2963016 n=20 Participants A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.	Lantus n=20 Participants A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
Maximum Glucose Infusion Rate (Rmax)	0.530 milligrams/kilogram/minute (mg/kg/min) Geometric Coefficient of Variation 254	0.611 milligrams/kilogram/minute (mg/kg/min) Geometric Coefficient of Variation 310

SECONDARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.

Gtot is the total glucose infusion over the clamp duration 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.

Outcome measures

Outcome measures
Measure	LY2963016 n=20 Participants A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.	Lantus n=20 Participants A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
Total Glucose Infused (Gtot)	4.60 milligrams/kilogram (mg/kg) Geometric Coefficient of Variation 1090	6.52 milligrams/kilogram (mg/kg) Geometric Coefficient of Variation 1160

SECONDARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.

tRmax is the time to reach maximum glucose infusion rate 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 study drug by adjusting the exogenous glucose infusion rate.

Outcome measures

Outcome measures
Measure	LY2963016 n=20 Participants A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.	Lantus n=20 Participants A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
Time of Maximum Glucose Infusion Rate (tRmax)	9.90 hours (hr) Interval 1.5 to 30.1	11.7 hours (hr) Interval 1.0 to 29.6

SECONDARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: No participants were analyzed because of insufficient data.

Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Periods 1 and 2: Baseline up to 42 hours postdose

Population: No participants were analyzed because of insufficient data.

AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.

Outcome measures

Outcome data not reported

Adverse Events

LY2963016

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Lantus

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LY2963016 n=20 participants at risk A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.	Lantus n=20 participants at risk A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
Gastrointestinal disorders Abdominal pain upper	5.0% 1/20 • Number of events 1	0.00% 0/20
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1	0.00% 0/20
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1	0.00% 0/20
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1	5.0% 1/20 • Number of events 1
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1	0.00% 0/20
Nervous system disorders Headache	5.0% 1/20 • Number of events 1	10.0% 2/20 • Number of events 2

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