NCT03465878

A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Completed Phase 1 Results posted Last updated 18 June 2020

What this trial tests

Phase 1 trial testing LY900014 in Type 1 Diabetes Mellitus in 56 participants. Completed in 14 November 2019.

Timeline

26 March 2018

Primary endpoint
14 November 2019

14 November 2019

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	56
Start date	26 March 2018
Primary completion	14 November 2019
Estimated completion	14 November 2019
Sites	2 locations across Canada, Germany

Drugs / interventions tested

• LY900014 — full drug profile →
• Insulin Lispro (INSULIN LISPRO) — full drug profile →

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 6 to 64, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part Primary · Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.

Group	Value	95% CI
Children-LY900014-Part A	755	± 15
Children-Humalog-Part A	754	± 17
Adolescents-LY900014-Part A	962	± 17
Adolescents-Humalog-Part A	908	± 21
Adults-LY900014-Part A	987	± 20
Adults-Humalog-Part A	975	± 21
Children-LY900014-Part B	743	± 17
Children-Humalog-Part B	714	± 17
Adolescents-LY900014-Part B	842	± 20
Adolescents-Humalog-Part B	866	± 16
Adults-LY900014-Part B	1100	± 35
Adults-Humalog-Part B	1070	± 35

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

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.

Group	Value	95% CI
Children-LY900014-Part A	384	± 335
Children-Humalog-Part A	492	± 270
Adolescents-LY900014-Part A	577	± 247
Adolescents-Humalog-Part A	651	± 238
Adults-LY900014-Part A	372	± 179
Adults-Humalog-Part A	351	± 240
Children-LY900014-Part B	602	± 221
Children-Humalog-Part B	582	± 254
Adolescents-LY900014-Part B	614	± 160
Adolescents-Humalog-Part B	614	± 163
Adults-LY900014-Part B	343	± 194
Adults-Humalog-Part B	401	± 235

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline to Study Completion (Up to 20 Months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Children-LY900014-Part A

Serious: 0/13 (0%)

Deaths: 0/13

Children-Humalog-Part A

Serious: 0/13 (0%)

Deaths: 0/13

Adolescents-LY900014-Part A

Serious: 1/14 (7%)

Deaths: 0/14

Adolescents-Humalog-Part A

Serious: 0/14 (0%)

Deaths: 0/14

Adults-LY900014-Part A

Serious: 0/14 (0%)

Deaths: 0/14

Adults-Humalog-Part A

Serious: 0/15 (0%)

Deaths: 0/15

Children-LY900014-Part B

Serious: 0/12 (0%)

Deaths: 0/12

Children-Humalog-Part B

Serious: 0/12 (0%)

Deaths: 0/12

Adolescents-LY900014-Part B

Serious: 0/13 (0%)

Deaths: 0/13

Adolescents-Humalog-Part B

Serious: 0/13 (0%)

Deaths: 0/13

Adults-LY900014-Part B

Serious: 0/12 (0%)

Deaths: 0/12

Adults-Humalog-Part B

Serious: 0/12 (0%)

Deaths: 0/12

Serious adverse events (1 terms)

Reaction	System	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
Injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (28 terms — click to expand)

Reaction	System	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
Injection site erythema	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Injection site discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Acne pustular	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Groin abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Leukocyturia	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—
Ovarian cyst ruptured	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Lipohypertrophy	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Injury.

Data from ClinicalTrials.gov NCT03465878 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacologic treatment options for type 1 diabetes: what's new?
   Nally LM, Sherr JL, Van Name MA, Patel AD, et al · · 2019 · cited 13× · PMID 30892094 · DOI 10.1080/17512433.2019.1597705
2. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5