Phase 3
Completed N=187
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Source: ClinicalTrials.gov NCT04605991 ↗Enrolled (actual)
187
Serious AEs
1.7%
Results posted
Mar 2023
Primary outcomePrimary: 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 — 3.8 Percentage of time
◆ Published Evidence
Emerging
5citations · ~2 / year
Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range.
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.
Linked Publications
-
Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3.8 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 |
-0.44 | — |
| SECONDARY 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 |
3.3 | — |
| SECONDARY 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 |
0.10; 0.00 | — |
| SECONDARY 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 |
-4.3; -3.4 | — |
| SECONDARY 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 |
-1.56; -1.07 | — |
| SECONDARY Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12 |
-1.57; -0.56; -2.76; -2.46 | — |
| SECONDARY Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12 |
-8.1; -2.57; -8.32; -8.8 | — |
| SECONDARY Percentage of Participants With HbA1c <7% and ≤6.5% |
16.88; 4.55 | — |
| SECONDARY Change From Baseline in Daily Insulin Dose at Week 12 |
3.7; 18.0; 22.0 | — |
| SECONDARY Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12 |
6.0 | — |
| SECONDARY Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12 |
16.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04605991) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.