NCT03736785

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Completed Phase 2 Results posted Last updated 8 March 2021

What this trial tests

Phase 2 trial testing LY3209590 in Type 2 Diabetes Mellitus in 399 participants. Completed in 18 February 2020.

Timeline

15 November 2018

Primary endpoint
18 February 2020

18 February 2020

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	399
Start date	15 November 2018
Primary completion	18 February 2020
Estimated completion	18 February 2020
Sites	44 locations across Puerto Rico, United States, Mexico

Drugs / interventions tested

• LY3209590 — full drug profile →
• Insulin Degludec (INSULIN DEGLUDEC) — full drug profile →

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Type 2 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.

Change From Baseline in HbA1c Primary · Baseline, Week 32

HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.

Group	Value	95% CI
LY3209590 Algorithm 1	-0.58	± 0.083
LY3209590 Algorithm 2	-0.57	± 0.085
Insulin Degludec	-0.66	± 0.084

Change From Baseline in HbA1c Compared to Insulin Degludec Secondary · Baseline, Week 32

HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.

Group	Value	95% CI
LY3209590 Algorithm 1	-0.58	± 0.083
LY3209590 Algorithm 2	-0.57	± 0.085
Insulin Degludec	-0.66	± 0.084

Change From Baseline in Fasting Glucose Secondary · Baseline, Week 32

Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry, HbA1c strata \[\<8.5% or ≥8.5%\]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.

Group	Value	95% CI
LY3209590 Algorithm 1	-13.1	± 4.01
LY3209590 Algorithm 2	-18.6	± 4.14
Insulin Degludec	-31.5	± 4.03

Change From Baseline in Insulin Dose (LY3209590) Secondary · Week 1, Week 32

The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.

Group	Value	95% CI
LY3209590 Algorithm 1	0.12	± 4.86
LY3209590 Algorithm 2	0.60	± 3.75

Change From Baseline in Insulin Dose (Insulin Degludec) Secondary · Baseline, Week 32

Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.

Group	Value	95% CI
Insulin Degludec	16.40	± 26.06

Rate of Total Documented Symptomatic Hypoglycemia Secondary · Baseline through week 32

The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.

Group	Value	95% CI
LY3209590 Algorithm 1	0.73	± 0.119
LY3209590 Algorithm 2	1.22	± 0.378
Insulin Degludec	1.56	± 0.375

Change From Baseline in Body Weight Secondary · Baseline, Week 32

Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.

Group	Value	95% CI
LY3209590 Algorithm 1	1.0	± 0.33
LY3209590 Algorithm 2	1.0	± 0.33
Insulin Degludec	2.0	± 0.33

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 Secondary · Week 32

PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.

Group	Value	95% CI
LY3209590 Algorithm 1	5360	± 67
LY3209590 Algorithm 2	5430	± 60

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 37 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LY3209590 Algorithm 1

Serious: 7/135 (5%)

Deaths: 1/135

LY3209590 Algorithm 2

Serious: 8/132 (6%)

Deaths: 0/132

Insulin Degludec

Serious: 10/132 (8%)

Deaths: 1/132

Serious adverse events (30 terms)

Reaction	System	LY3209590 Algorithm 1	LY3209590 Algorithm 2	Insulin Degludec
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Chronic gastritis	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Chest pain	General disorders	—	—	—
Non-cardiac chest pain	General disorders	—	—	—
Sudden cardiac death	General disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Abscess limb	Infections and infestations	—	—	—
Cellulitis	Infections and infestations	—	—	—
Meningitis viral	Infections and infestations	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Psoas abscess	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—
Syncope	Nervous system disorders	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	LY3209590 Algorithm 1	LY3209590 Algorithm 2	Insulin Degludec
Upper respiratory tract infection	Infections and infestations	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Hypoglycaemia, Acute myocardial infarction, Chronic gastritis, Nausea, Pancreatitis acute, Vomiting, Chest pain, Non-cardiac chest pain.

Data from ClinicalTrials.gov NCT03736785 adverse events section.

Sponsor's own description

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

Publications & conference data

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

1. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study.
   Frias J, Chien J, Zhang Q, Chigutsa E, et al · · 2023 · cited 38× · PMID 36758572 · DOI 10.1016/s2213-8587(22)00388-6
2. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
3. Once-weekly Basal Insulin Fc versus daily insulin degludec for glycemic control in diabetes: a systematic review, meta-analysis, and meta-regression.
   Raja S, Raja A, Ali A, Asghar MS. · · 2025 · cited 4× · PMID 40123989 · DOI 10.1007/s40200-025-01602-y