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CompletedNCT01784211Updated Mar 15, 2019Results posted

A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes

A Phase 1 interventional study of LY2605541 and Insulin Glargine in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to measure how much of the study drug or insulin glargine gets into the blood stream and how long it takes the body to get rid of it. The effect of exercise will also be evaluated.

This study has two parts. In Part A, each participant will receive a daily injection of LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B. In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with or without exercise. Part B lasts about 6 days.

Participants will remain on their regular physician-prescribed mealtime insulin throughout the study.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 76 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are males or females that have had a diagnosis of Type I Diabetes Mellitus (T1DM) for at least 12 months and are receiving multiple daily insulin injections. Total daily insulin dose \<1.2 units per kilogram per day (U/kg/day); daily basal dose >0.2 U/kg/day
  • Female participants: are women of child-bearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study
  • Have a body mass index (BMI) of 18 to 30 kilograms per meter squared (kg/m\^2), inclusive
  • Have a fasting c-peptide \<0.3 nanomoles per liter (nmol/L)
  • Have a hemoglobin A1c (HbA1c) \<9% at screening

Participants with T1DM are eligible for enrollment in Part B of the study only if they meet all of the following criteria:

  • Have a maximal oxygen uptake (VO2 max) of ≥25 milliliters (mL) of oxygen per kilogram per minute (O2/kg/min) (for women) or ≥30 mL O2/kg/min (for men)
  • Perform regular physical cardiorespiratory activity to achieve an average total energy expenditure of ≥500 metabolic equivalent of task (MET)-minutes per week during the last 3 months prior to screening

Exclusion criteria

Exclusion Criteria:

  • Have known allergies to LY2605541, insulin glargine, related compounds or any components of the formulation
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Have had episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)
  • Have a history of hypoglycemia unawareness
  • Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that may affect blood glucose, the body's sensitivity to insulin, or that promote weight loss within 14 days prior to dosing
  • Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to comply with study requirements regarding alcohol consumption
  • Currently smokes >5 cigarettes per day, or are unwilling to comply with study requirements regarding smoking or use of tobacco products
  • Have a hemoglobin level \<8.0 millimoles per liter (mmol/L) (male) or \<6.4 mmol/L (female) at screening
  • Are currently participating in a weight loss program or plan to do so during the course of the study
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and intra-ocular preparations) or have received such therapy within the 4 weeks before dosing
  • Have fasting triglycerides >400 milligrams per deciliter (mg/dL) (4.52 mmol/L)
  • Have previous history or family history of deep vein thrombosis
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    LY2605541 (Part A)

    0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. Participants remained on their regular physician-prescribed mealtime insulin.

    Drug: LY2605541

  • Active comparator
    Glargine (Part A)

    0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. Participants remained on their regular physician-prescribed mealtime insulin.

    Drug: Insulin Glargine

  • Experimental
    First LY2605541 + Exercise,Then LY2605541 Alone (Part B)

    0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20).Participants remained on their regular physician-prescribed mealtime insulin.

    Drug: LY2605541

  • Experimental
    First LY2605541 Alone, Then LY2605541 + Exercise (Part B)

    0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17). Participants remained on their regular physician-prescribed mealtime insulin.

    Drug: LY2605541

  • Active comparator
    First Glargine + Exercise, Then Glargine Alone (Part B)

    0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20). Participants remained on their regular physician-prescribed mealtime insulin.

    Drug: Insulin Glargine

  • Active comparator
    First Glargine Alone, Then Glargine + Exercise (Part B)

    0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17).

    Drug: Insulin Glargine

Interventions

06

What researchers measure

Primary outcomes

  1. Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability

    Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

    Time frame: Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14

  2. Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability

    Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

    Time frame: Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14

Secondary outcomes

  1. Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability

    Glucodynamic measurements were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

    Time frame: Part A: Predose up to 24 hours postdose on Days 8, 11, and 14

  2. Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise

    Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.

    Time frame: Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19

  3. Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise

    Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.

    Time frame: Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19

07

Results

Posted Mar 15, 2019

Participant flow

Part A is 2- arm parallel open label. Part B is a crossover study with 2 treatment arms (LY2605541 \& Glargine), each treatment arm consists of 2 sequences. Sequence 1: participants received treatment on days 16,17,18,19 \& 20 with exercise on day 17. Sequence 2: participants received treatment on days 16,17,18,19, \& 20 with exercise on day 20.

Part A (Days 1-15)
Participant flow — Part A (Days 1-15)
MilestoneLY2605541 (Part A)Glargine (Part A)First LY2605541 + Exercise, Then LY2605541 Alone (Part B)First LY2605541 Alone, Then LY2605541 + Exercise (Part B)First Glargine + Exercise, Then Glargine Alone (Part B)First Glargine Alone, Then Glargine + Exercise (Part B)
Started38380000
Received at least 1 dose of study drug37380000
Entered part b19210000
Completed35360000
Not completed320000
Withdrew: Adverse event110000
Withdrew: Withdrawal by subject210000
Part B (Days 16-21)
Participant flow — Part B (Days 16-21)
MilestoneLY2605541 (Part A)Glargine (Part A)First LY2605541 + Exercise, Then LY2605541 Alone (Part B)First LY2605541 Alone, Then LY2605541 + Exercise (Part B)First Glargine + Exercise, Then Glargine Alone (Part B)First Glargine Alone, Then Glargine + Exercise (Part B)
Started001091110
Completed001091110
Not completed000000

Outcome measures

PrimaryPart A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability

Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

Time frame:
Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14
Reported as:
Number · %CV
Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability
%CVLY2605541 (Part A)Glargine (Part A)
Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability11.3 (9.89 to 13.2)19.2 (15.5 to 25.5)
PrimaryPart A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability

Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

Time frame:
Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14
Reported as:
Number · %CV
Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability
%CVLY2605541 (Part A)Glargine (Part A)
Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability12.6 (11.0 to 14.7)27.7 (23.8 to 33.3)
SecondaryPart A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability

Glucodynamic measurements were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.

Time frame:
Part A: Predose up to 24 hours postdose on Days 8, 11, and 14
Reported as:
Number · %CV
Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability
%CVLY2605541 (Part A)Glargine (Part A)
Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability41.4 (36.1 to 49.0)63.9 (55.2 to 76.6)
SecondaryPart B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise

Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.

Time frame:
Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19
Reported as:
Geometric mean · picomoles*hour per liter (pmol*h/L)
Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise
picomoles*hour per liter (pmol*h/L)LY2605541 + Exercise (Part B)LY2605541 (Part B)Glargine + Exercise (Part B)Glargine (Part B)
Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise147000 ± 25130000 ± 232950 ± 242650 ± 23
SecondaryPart B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise

Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.

Time frame:
Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19
Reported as:
Geometric mean · picomoles per liter (pmol/L)
Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise
picomoles per liter (pmol/L)LY2605541 + Exercise (Part B)LY2605541 - No Exercise (Part B)Glargine + Exercise (Part B)Glargine - No Exercise (Part B)
Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise11100 ± 276760 ± 28166 ± 51153 ± 35

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LY2605541 (Part A and Part B)—1/37 (2.7%)10/37 (27%)
Glargine (Part A and Part B)—0/38 (0%)12/38 (31.6%)
Most frequent serious events
Most frequent serious events
EventLY2605541 (Part A and Part B)Glargine (Part A and Part B)
HypoglycaemiaMetabolism and nutrition disorders1/370/38
Most frequent other events
Most frequent other events
EventLY2605541 (Part A and Part B)Glargine (Part A and Part B)
HeadacheNervous system disorders8/377/38
DiarrhoeaGastrointestinal disorders0/372/38
Back painMusculoskeletal and connective tissue disorders1/372/38
PresyncopeNervous system disorders1/372/38

Baseline characteristics

All participants who were randomized and received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)LY2605541 (Part A)Glargine (Part A)Total
Mean43.2 ± 10.842.0 ± 12.142.6 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)LY2605541 (Part A)Glargine (Part A)Total
Female41115
Male332760
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LY2605541 (Part A)Glargine (Part A)Total
White363874
Multiple101
Region of Enrollment
Region of Enrollment(Participants)LY2605541 (Part A)Glargine (Part A)Total
Germany373875
08

Study locations

1 site
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Neuss, Germany
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Nov 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2019, 5 years 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2013
First posted
Feb 5, 2013
Start
Feb 2013
Primary completionActual
Nov 2013
CompletionActual
Nov 2013
Results first posted
Mar 15, 2019
Last update
Mar 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01784211
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Feb 5, 2013
Start date
Feb 2013
Primary completion
Nov 2013
Completion
Nov 2013
Results posted
Mar 15, 2019
Last update
Mar 15, 2019

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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