A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Browse trials for

• Diabetes Mellitus 10,923
• Diabetes Mellitus, Type 2 9,357

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 278 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  LY3209590 Algorithm 1 (Paper)

  Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the baseline median fasting glucose and body weight by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL).

  Drug: LY3209590

• Experimental
  LY3209590 Algorithm 2 (Digital)

  Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the baseline median fasting glucose and body weight by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.

  Drug: LY3209590

• Active comparator
  Insulin Degludec

  Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.

  Drug: Insulin Degludec

Interventions

• DrugLY3209590

  Administered SC

• DrugInsulin Degludec

  Administered SC

Primary outcomes

1. Change From Baseline in Hemoglobin A1c (HbA1c)

   HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) \[\<30, \>=30\]), visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.

   Time frame: Baseline, Week 26

Secondary outcomes

1. Change From Baseline in Fasting Serum Glucose

   LS mean change from baseline was analysed by MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI \[\<30, \>=30\]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.

   Time frame: Baseline, Week 26

2. Rate of Documented Hypoglycemia

   Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose \<54 mg/dL (3.0 millimole per liter (mmol/L)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period\*365.25 days.

   Time frame: Baseline through Week 26

3. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

   AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.

   Time frame: Week 26

Baseline characteristics

Related links

• A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus ↗

Study documents

• Study protocol · Oct 28, 2020
• Statistical analysis plan · Sep 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr