Comparative effectiveness and safety of different basal insulins in a real-world setting
Open accessAbstract
Aims: To compare glucose control and safety of different basal insulin therapies ( BI , including I nsulin NPH , glargine and detemir) in real‐world clinical settings based on a large‐scale registry study. Methods: In this multi‐center 6‐month prospective observational study, patients with type 2 diabetes ( HbA1c ≥ 7%) who were uncontrolled by oral anti‐diabetic drugs ( OADs ) and were willing to initiate BI therapy were enrolled from 209 hospitals within 8 regions of C hina. Type and dose of BI were at the physician's discretion and the patients’ willingness. Interviews were conducted at 0 months (visit 1), 3 months (visit 2) and 6 months (visit 3). Outcomes included change in HbA1c , hypoglycemia rate and body weight from baseline at 6 months. Results: A total of 16 341 and 9002 subjects were involved in I ntention‐ T o‐ T reat ( ITT ) and per‐protocol ( PP ) analysis, respectively. After PS regression adjustment, ITT analysis showed that reduction in HbA1c in glargine (2.2% ± 2.1%) and detemir groups (2.2% ± 2.1%) was higher than that in the NPH group (2.0% ± 2.2%) ( P < .01). The detemir group had the lowest weight gain (−0.1 ± 2.9 kg) compared with the glargine (+0.1 ± 3.0 kg) and NPH (+0.3 ± 3.1 kg) groups ( P < .05). The glargine group had the lowest rate of minor hypoglycaemia, while there was no difference in severe hypoglycaemia among the 3 groups. The results observed in PP analyses were consistent with those in ITT analysis. Conclusion: In a real‐world clinical setting in C hina, treatment with long‐acting insulin analogues was associated with better glycaemic control, as well as less hypoglycaemia and weight gain than treatment with NPH insulin in type 2 diabetes patients. However, the clinical relevance of these observations must be interpreted with caution.
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Studies of insulin users involved mostly persons with type 1 diabetes.
“Studies of insulin users involved mostly persons with T1D,”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1065]
The Patient Population section says this study enrolled people with established type 2 diabetes, not type 1 diabetes. The Introduction also describes insulin trials and observational studies in people with type 2 diabetes; it does not characterize the studies it discusses as mostly involving people with type 1 diabetes. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredUsing a basal insulin analog as the only insulin for type 2 diabetes is associated with considerably lower hypoglycemia rates than older insulin preparations or basal-bolus treatment.
“but the use of a basal insulin analog as the sole administered insulin for T2D is associated with considerably lower hypoglycemia rates than older insulin preparations or the use of basal-bolus treatment.1065”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1065]
The Discussion (page not supplied) reports significantly lower documented symptomatic and overall hypoglycemia with glargine or detemir than with NPH insulin; it also says the analysis of patients continuing basal insulin alone was consistent. The paper does not compare basal-only treatment with basal-bolus treatment, and it found no significant difference in severe hypoglycemia among the basal insulin groups. (LLM, conf=0.88)
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Flagged first, then by citations
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- [38]38. Ji, L., Zhang, P., Zhu, D., Lu, J., Guo, X., Wu, Y., Li, X., Ji, J., Jia, W., Yang, W., Zou, D., Zhou, Z., Gao, Y., Garg, S. K., Pan, C., Weng, J. & Paul, S. K. (2017). Comparative effectiveness and safety of different basal insulins in a real-world setting. DIABETES OBESITY & METABOLISM, 19 (8), pp.1116-1126. https://doi.org/10.1111/dom.12920. Persistent Link: http://hdl.handle.net/11343/292738
Cited by
Sorted by citations
Blonde, L., Umpierrez, G. E., Reddy, S. S., McGill, J. B., Berga, S. L., Bush, M., Chandrasekaran, S., DeFronzo, R. A., Einhorn, D., Galindo, R. J., et al. (2022) · Endocrine Practice · doi:10.1016/j.eprac.2022.08.002 · Cited by 507 · see citing works
- Authors
- Ji, L., Zhang, P., Zhu, D., Lu, J., Guo, X., Wu, Y., Li, X., Ji, J., Jia, W., Yang, W., Zou, D., Zhou, Z., Gao, Y., Garg, S. K., Pan, C., Weng, J., Paul, S. K., & on behalf of the ORBIT study group
- Affiliations
- Peking University (CN)
- Chinese People's Liberation Army (CN)
- Peking University First Hospital (CN)
- Shanghai Jiao Tong University (CN)
- China-Japan Friendship Hospital (CN)
- Second Military Medical University (CN)
- Second Xiangya Hospital of Central South University (CN)
- University of Colorado Denver (US)
- Third Affiliated Hospital of Sun Yat-sen University (CN)
- The University of Melbourne (AU)
- Corresponding author
- Ji, Linong
- Pan, Changyu
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2017-04-03
- Volume
- 19
- Issue
- 8
- Pages
- 1116-1126
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W2589735890
- Cited by
- 13
- References
- 35
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 3 · 2019: 2 · 2018: 1 · 2017: 3
- FWCI
- 1.95
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion)
- Funders
- Sanofi-Aventis (Shanghai, China)
- Australian Government's National Collaborative Research Infrastructure Strategy (NCRIS)
- 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
- basal insulin, type 2 diabetes, insulin glargine, insulin detemir, NPH insulin, long-acting insulin analogues, glycemic control, HbA1c, hypoglycemia, weight gain, real-world effectiveness, comparative effectiveness
- MeSH terms
- Insulin Glargine, Insulin Detemir, China, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Drug Resistance, Drug Therapy, Combination, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Isophane, Prospective Studies, Registries, Severity of Illness Index, Weight Gain, Drug Monitoring, Intention to Treat Analysis, Lost to Follow-Up
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