Insulin Efsitora Alfa
DrugAdministered SC
Other names: LY3209590 and Basal Insulin-FC
NCT Number: NCT05462756
The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Other names: LY3209590 and Basal Insulin-FC
Administered SC
Other names: Humalog
Administered SC
Other names: Basaglar
Time frame: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Week 26
Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia [<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.
Time frame: Baseline Up To Week 26
The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose <54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.
Time frame: Baseline, Week 26
Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).
Time frame: Week 22 to Week 26
Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.
Time frame: Week 22 to Week 26
Percentage of Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM.
Time frame: Week 22 to Week 26
Percentage of Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM.
Time frame: Week 22 to Week 26
Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.
Time frame: Week 26
Average weekly basal Insulin Dose at Week 26 was reported.
Time frame: Week 26
Average daily bolus Insulin Dose at Week 26 was reported.
Time frame: Week 26
Average total weekly insulin dose at Week 26 was reported.
Time frame: Week 26
Basal insulin dose to total insulin dose ratio at Week 26 was reported.
Time frame: Baseline up to Week 26
Hypoglycemia event rate was reported. Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported here.
Time frame: Baseline, Week 26
Change from baseline in body weight was reported.
Time frame: Week 26
The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics
Eli Lilly and Company
Industry
A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections
Acronym: QWINT-4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05893797
Autoimmune Diseases, Diabetes Mellitus
Strasbourg, Alsace, France
View Trial DetailsNCT03070106
Diabetes, Diabetes Mellitus
Cleveland, Ohio, United States
View Trial DetailsNCT06519903
Diabetes Mellitus, Diabetes Mellitus, Type 2
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT04274660
Diabetes Mellitus, Diabetes Mellitus, Type 2
Ghent, Belgium
View Trial Details