Randomized double-blind clinical trial comparing ultra rapid lispro with lispro in a basal-bolus regimen in patients with type 2 diabetes: PRONTO-T2D
Open accessAbstract
OBJECTIVE: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS: This was a phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi (n = 336) or lispro (n = 337) injected 0–2 min prior to meals. Patients could continue metformin and/or a sodium–glucose cotransporter 2 inhibitor. The primary end point was change in HbA1c from baseline to 26 weeks (noninferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test. RESULTS: HbA1c improved for both URLi and lispro, and noninferiority was confirmed: estimated treatment difference (ETD) 0.06% (95% CI −0.05; 0.16). Mean change in HbA1c was −0.38% for URLi and −0.43% for lispro, with an end-of-treatment HbA1c of 6.92% and 6.86%, respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-h ETD, −0.66 mmol/L (95% CI −1.01, −0.30); 2-h ETD, −0.96 mmol/L (−1.41, −0.52). Significantly lower PPG excursions were evident from 0.5 to 4.0 h postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3.0 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments. CONCLUSIONS: URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA1c and superior to lispro for PPG control in patients with type 2 diabetes.
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Analog premixed insulins provide better glycemic control with less hypoglycemia than traditional premixed NPH regimens.
“Nevertheless, there are some persons for whom a simpler regimen is a reasonable compromise, and for this population, analog premixed insulins will provide better glycemic control with less hypoglycemia than the traditional, more affordable premixed NPH regimens.1080”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1080]
The Conclusions (page unavailable) compare ultra rapid lispro with lispro in a basal-bolus regimen, not analog premixed insulin with premixed NPH. Searches for premixed NPH and for premixed versus human insulin found no passage addressing the claimed difference in glycemic control or hypoglycemia. (LLM, conf=0.78)
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Chow, E., & Chan, J. C. N. (2022) · 中国科学通报：英文版 · doi:10.1016/j.scib.2022.11.025 · Cited by 1 · see citing works
Au-delà des insulines actuelles : des réalisations prometteuses et quelques désillusions
Monnier, L., Colette, C., Azrak, A. E., Essekat, N., & Rochd, D. (2022) · Médecine des Maladies Métaboliques · doi:10.1016/j.mmm.2022.12.002 · Cited by 1 · see citing works
Significant publications in diabetes pharmacotherapy and technology in 2020
Clements, J. N., Franks, R. B., Isaacs, D. M., Malloy, K., Meade, L. T., Reece, S. W., Reid, D. J., & Ward, E. D. (2023) · Expert Review of Endocrinology & Metabolism · doi:10.1080/17446651.2023.2187779 · Cited by 1 · see citing works
RetractedMačáková, D., Krystyník, O., Cibičková, Ľ., & Karásek, D. (2024) · Vnitřní lékařství · doi:10.36290/vnl.2024.009 · Cited by 1 · see citing works
Hamann, A. (2021) · Der Diabetologe · doi:10.1007/s11428-021-00783-3 · Cited by 1 · see citing works
Efficacy and Safety of Ultra-Rapid Lispro Versus Lispro in Patients with Type 1 and 2 Diabetes
Bhattacharyya, A., Bhattacharya, I., Deshmukh, V. C., Mohan, V., & Spaepen, E. (2022) · Indian Journal of Endocrinology and Metabolism · doi:10.4103/ijem.ijem_459_21 · Cited by 1 · see citing works
Ultraschnelles Insulin Lispro verbessert die postprandiale Blutzuckerkontrolle
(2021) · Diabetologie und Stoffwechsel · doi:10.1055/a-1332-6465
Short‐acting Insulin Analogues
and, K. H., & McKay, G. (2022) · Wiley eBooks · doi:10.1002/9781119785033.ch8
Insulin: 100 years but not over the hill! A treatment with potential for renewal
Valenzano, M. (2022) · The Journal of AMD · doi:10.36171/jamd22.25.2
Davidson, M. B. (2023) · Clinical Diabetes · doi:10.2337/cd22-0106
Significant publications in diabetes pharmacotherapy and technology in 2020
Clements, J. N., Franks, R. B., Isaacs, D. M., Malloy, K., Meade, L. T., Reece, S. W., Reid, D. J., & Ward, E. D. (2023) · Expert Review of Endocrinology & Metabolism · doi:10.1080/17446651.2023.2187618
Focus on a special tool for postprandial glucose control: Ultra rapid lispro
Zhou, L., Qu, D., & Zhao, X. (2023) · Chinese Science Bulletin (Chinese Version) · doi:10.1360/tb-2023-0508
Yuan, L., Luo, Y., Luo, Y. L., Ding, B., Zhang, P., Ma, J., & Wu, J.-D. (2024) · Frontiers in Endocrinology · doi:10.3389/fendo.2024.1364585
Demidova, T. Y., Galstyan, G. R., & Titova, V. V. (2024) · FOCUS Endocrinology · doi:10.62751/2713-0177-2024-5-2-20
Hajika, Y., & Kawaguchi, Y. (2025) · Metabolism Open · doi:10.1016/j.metop.2025.100377
Effectiveness of Using Patient-Defined Meal Sizes to Determine Bolus Doses of Insulin
Davidson, M. B., Scarlett, L., Duran, P. A., JENNE, K. W., Shinn, P., & Woodcock, E. (2026) · Diabetes Obesity and Cardiometabolic CARE · doi:10.2337/doc25-0018
- Authors
- Blevins, T., Zhang, Q., Frias, J. P., Jinnouchi, H., & Chang, A. M.
- Affiliations
- Texas Diabetes & Endocrinology (US)
- Eli Lilly (United States) (US)
- National Research Institute, Los Angeles, CA
- Jinnouchi Hospital, Kumamoto, Japan
- Corresponding author
- Chang, Annette M.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2020-07-02
- Volume
- 43
- Issue
- 12
- Pages
- 2991-2998
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC7770265
- OpenAlex
- W3039681635
- Cited by
- 69
- References
- 34
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 9 · 2023: 13 · 2022: 14 · 2021: 20 · 2020: 10
- FWCI
- 10.75
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Diabetes Care (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- insulin lispro, type 2 diabetes, multiple daily insulin injections, prandial insulin, HbA1c, postprandial glucose excursions, non-inferiority, hypoglycemia, insulin pharmacokinetics
- MeSH terms
- Insulin Glargine, Equivalence Trials as Topic, Sodium-Glucose Transporter 2 Inhibitors, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Male, Metformin, Middle Aged, Treatment Outcome, Postprandial Period, Insulin, Long-Acting, Insulin Lispro, Meals
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