A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
- Registration Number
- NCT04605991
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
-
Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
-
Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:
- Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
- Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
-
Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
- Metformin
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- sodium glucose cotransporter 2 (SGLT2) inhibitor
- oral glucagon-like peptide 1 (GLP-1) agonist
-
Doses of OAMs are required to have been stable for at least 90 days prior to screening.
-
Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
-
Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.
- Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
- Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
- Have hypoglycemia unawareness as judged by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY900014 LY900014 LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study. LY900014 Insulin Glargine LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.
- Primary Outcome Measures
Name Time Method Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12 Baseline, Week 12 Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Baseline, Week 12 HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12 Baseline, Week 12 iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from Glucose measures taken every 15 minutes from 0 to 1 hour after meal using CGM sensor (i.e., 0, 15, 30, 45, 60 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12 Baseline, Week 12 iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from glucose measures taken every 15 minutes from 0 to 2 hours after meal using CGM sensor (i.e., 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.
Percentage of Participants With HbA1c <7% and ≤6.5% Week 12 HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Daily Insulin Dose at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12 Baseline, Week 12 LS mean was determined by MMRM model with Baseline + Time as variables.
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12 Baseline, Week 12 The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for subjects taking insulin under 5 domains: Inconvenience of Regimen \[IR - 5 items\], Lifestyle Flexibility \[LF - 3 items\], Glycemic Control \[GC - 3 items\], Hypoglycemic Control \[HC - 5 items\], Insulin Delivery Device \[IDD - 6 items\]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. Data presented are for Glycemic Control Domain Scores transformed on a 0-100 scale, where transformed domain score = 100×\[(7-raw domain score)/6\]. Higher scores indicate better glycemic control. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as a covariate.
Trial Locations
- Locations (31)
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
East Coast Institute for Research at The Jones Center
🇺🇸Macon, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Suny Health Science Center at Syracuse
🇺🇸Syracuse, New York, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Endocrine Ips, Pllc
🇺🇸Houston, Texas, United States
Cataret Medical Group
🇺🇸Morehead City, North Carolina, United States
AMCR Institute
🇺🇸Escondido, California, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Valley Endocrine, Fresno
🇺🇸Fresno, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Coastal Metabolic Research Centre
🇺🇸Ventura, California, United States
CMR of Greater New Haven
🇺🇸Hamden, Connecticut, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Maryland Cardiovascular Specialists
🇺🇸Baltimore, Maryland, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Research NYC, Inc
🇺🇸New York, New York, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Advanced Clinical Research, LLC
🇵🇷Bayamon, Puerto Rico
Manati Center for Clinical Research Inc
🇵🇷Manati, Puerto Rico
Sun Coast Clinical Research, Inc
🇺🇸New Port Richey, Florida, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Burke Internal Medicine and Research
🇺🇸Burke, Virginia, United States