Efficacy and safety of oral insulin compared to subcutaneous insulin: a systematic review and meta-analysis

Akbari, Vajihe; Hendijani, Fatemeh; Feizi, Awat; Varshosaz, Jaleh; Fakhari, Z.; Morshedi, S; Mostafavi, Sayed Abolfazl

doi:10.1007/s40618-015-0326-3

Cited by 17 publications

(9 citation statements)

References 42 publications

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“…Oral administration of basal insulin would avoid injections and may also deliver the insulin in a more physiologic manner through absorption through the portal vein [101]. Some studies have shown no significant difference orally and subcutaneously administered insulin in terms of PK, PD, and safety parameters, but larger and longer trials are still needed [102].…”

Section: Future Trends Of Insulinsmentioning

confidence: 99%

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

et al. 2020

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Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin \ 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11310668.

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Section: Future Trends Of Insulinsmentioning

confidence: 99%

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

et al. 2020

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“…Seeking innovative strategies to improve treatment compliance for antidiabetic medications might be an effective approach for optimal glycemic control 7–11 . Although subcutaneous insulin injection remains the last choice for patients with type 2 diabetes mellitus (T2DM) and the essential treatment for those with type 1 diabetes mellitus (T1DM), long‐term insulin injection could inevitably increase psychological stress due to pain in the injection site, side effects such as local hypertrophy, skin allergy, and an increased occurrence of hypoglycemia 12,13 . All these effects decreased the acceptance and efficiency of insulin therapy.…”

mentioning

confidence: 99%

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial

Zhang

Zhou

Shen

et al. 2022

Clinical Pharm in Drug Dev

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Oral delivery is an ideal method of insulin administration and is currently a promising research field. Here, we evaluated the safety, pharmacokinetic, and pharmacodynamic characteristics of oral administration of an insulin capsule (ORMD-0801) with 2 different sources of recombinant human insulin. This was a single-center, randomized, double-blind, placebocontrolled, dose-escalating phase 1 trial. Single dosing of the oral insulin capsule was administered in 70 healthy Chinese subjects. In stage 1, four dose groups (8, 16, 32, and 48 mg) for capsules containing Sanofi insulin and in stage 2, three dose groups (8, 32, and 48 mg) containing Hefei Tianmai insulin were evaluated consequently. The results showed that the oral insulin formulations with either source in the dose range 8 to 48 mg were safe, and no serious adverse events were observed. After a standard breakfast 45 minutes after dosing, the area under the concentration-time curve (AUC) from time 0 to time t and AUC from time 0 to infinity for insulin in the 8-mg and 48-mg dose groups in stage 1 and for 8-to 48-mg groups in stage 2 were slightly increased compared with placebo, but no significant dose-related changes in the pharmacokinetic parameters were observed for either stage. The peak-valley difference and the change in value of the AUC for glucose from baseline showed a dose-related increase in the dose range from 8 to 48 mg in both stages. Together, this study indicated that in healthy Chinese subjects, this oral capsule containing 2 different insulin formulations was safe and well tolerated after a single-dose administration.

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“…Oral INS can mimic the natural physiologic route of INS through the portal vein and direct engagement of the liver (Akbari et al., 2016 ). Owing to the first-pass hepatic extraction, 50% of the INS is degraded in the liver (Kanzarkar et al., 2015 ).…”

Section: Discussionmentioning

confidence: 99%

“…Diabetes mellitus is one of the most common chronic metabolic disease due to lack of insulin (INS) (T1DM) or INS resistance (T2DM) (Sousa et al., 2015 ; Wong et al., 2016 ). Diabetes can be controlled by subcutaneous ( s.c. ) injection with INS (Lopes et al., 2015 ; Akbari et al., 2016 ). Generally, the typical diabetic patients require more than 60,000 injections throughout lives, but the multiple daily injection is with low compliance for patients, such as painful, inconvenient and uncomfortable (Wong et al., 2016 ).…”

Section: Introductionmentioning

confidence: 99%

Enteric-coated insulin microparticles delivered by lipopeptides of iturin and surfactin

et al. 2017

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Surfactin, a lipopeptide produced by Bacillus species, has been used for the oral delivery of insulin. In this study, another lipopeptide of iturin was tested for its ability to orally delivery insulin alone or plus surfactin. Iturin could form co-precipitate with insulin at acidic pH values. After treatment by ultrasonification, the structure of coprecipitate was destroyed that led to a significant decrease in hypoglycemic effect after oral administration. Iturin weakly binds to (Kd = 257 μM) and induce insulin structure more compact that is favorable for insulin uptake by the intestine. After being coated with Acryl-Eze by lyophilization, the coprecipitate formed the spherical enteric-coated insulin microparticles delivered by iturin with a relative oral bioavailability of 6.84% in diabetic mice. For further improving oral hypoglycemic effect, surfactin was added to form the spherical enteric-coated insulin microparticles in a formulation containing insulin, Acryl-Eze, iturin and surfactin at a ratio of 1:1:0.5: 0.5 (w/w), with an insulin encapsulation efficiency of 66.22%. The enteric-coated insulin microparticles delivered by iturin plus surfactin showed a classical profile for controlled release in the intestine with a relative bioavailability of 7.67% after oral administration, which could effectively control the postprandial blood glucose at a level about 50% of the initial one just like the subcutaneous injection. Collectively, iturin plus surfactin is more efficient for oral delivering insulin than the sole one, and the resultant enteric-coated insulin microparticles are potential for the development of oral insulin to control postprandial blood glucose in diabetic patients.

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Efficacy and safety of oral insulin compared to subcutaneous insulin: a systematic review and meta-analysis

Abstract: This systematic review and meta-analysis showed that oral insulin is comparable to SC insulin with regard to glycemic efficacy and safety. However, is necessary to conduct additional studies in which oral insulin administered to large number of patients for long enough periods of time.

Cited by 17 publications

References 42 publications

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial

Enteric-coated insulin microparticles delivered by lipopeptides of iturin and surfactin

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