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Safety in Lactation: Insulins

23 September 2020Exogenous insulin is excreted into breast milk, including that from insulin analogues. Insulin in breast milk is thought to be necessary for intestinal maturation of…

Insulin preparations: RMOC recommendations of safety considerations for formulary decision making

22 June 2018At its meeting on 18th April 2018 the Regional Medicines Optimisation Committee (RMOC) (Midlands and East) reviewed issues pertaining to safety considerations when adopting any…
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Refrigerated Storage

HumalogEli Lilly

Eli Lilly
Humalog
100 units/ml solution for injection vial, cartridge and kwikpen and 200 units/ml Kwikpen

In the event of an inadvertent temperature excursion the following data may be used:
After cartridge insertion or first use (pre-filled pen), Store below 30°C for 28 days. Do not refrigerate.
After first use (vials only), Store in a refrigerator (2°C – 8°C) or below 30°C for 28 days.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce expiry to 28 days
See above
20 May 2019
London MI Service

Lactation Safety Information

Yes
Likely to be degraded in infant's GI tract
Short-acting recombinant human insulin
11 September 2020

New Medicines

Insulin lispro Sanofi (EU); Admelog (US)Type 1 and 2 diabetes mellitus

Information

Insulin lispro Sanofi (EU); Admelog (US)
Biosimilar
Sanofi
Sanofi

Development and Regulatory status

Launched
Launched
Launched
June 2018
Jun 19Admelog has been available in the US since Apr 18 [9].
Jun 18Launched in UK. Price: 1 x 10ml vial=£14.12 5 x 3ml cartridges=£24.06 5 x 3ml SoloStar prefilled pen=£25.04 [8]
Dec 17Approved in US
Sep 17The FDA has granted tentative, but not final approval in the US. Sanofi has 45 days to notify Lilly who may choose to sue for infringement on its remaining patent covering the KwikPen injection device. Alternatively the parties could settle on a mutually agreeable launch date [5]. 
May 17EU positive opinion for treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus [4].
Apr 17Approved in EU [7].
Oct 16Filed in EU via centralised procedure [3].
Sep 16SORELLA top-line results were expected in Q2 16 [1].

Category

Rapid-acting analogue of human insulin, for the treatment of diabetes mellitus. Insulin lispro exists in a monomeric form in solution, and is created by inversion of the amino acid sequence of human insulin at positions B28 and B29, Lys(B28), Pro(B29)
In 2011 the UK prevalence of diabetes was 4.45% (about 2.9 million people). It is thought a further 850,000 are undiagnosed. The prevalence is projected to increase to 5 million people by 2025. About 90% of patients with diabetes have type 2 disease.
Type 1 and 2 diabetes mellitus
Subcutaneous injection

Trial or other data

Jul 16Sanofi completes the randomised, open-label PIII SORELLA 1 trial in patients with type I diabetes mellitus who were also using insulin glargine (NCT02273180; EudraCT2013-002945-12). The trial assessed the safety and efficacy of SAR 342434, compared with insulin lispro (Humalog®)and enrolled 507 patients in the US, France, Germany, Hungary, Japan, Poland, Russia and Spain [2].
Feb 16Sanofi completes the PIII SORELLA 2 trial, that was designed to demonstrate non-inferiority of insulin lispro versus insulin glargine in patients with type II diabetes mellitus (NCT02294474; EudraCT2014-002844-42). The randomised, open-label trial enrolled 505 patients in the US, Argentina, Chile, Colombia, South Korea, Romania, Russia, Hungary, Germany, Italy, Spain and Turkey [2].

LyumjevType 1 and 2 diabetes mellitus in adults

Information

Lyumjev
New formulation
Eli Lilly
Eli Lilly

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
July 2020
Jul 20Available in the UK in two strengths (100 units/ml and 200 units/ml) [9].
Jan 20Recommended for EU approval by CHMP - the full indication is "Treatment of diabetes mellitus in adults” [8].
Jun 19Filed in the EU & Japan. To be filed in the US later in 2019 [7].
Oct 17PIII trials have started [1].

Category

An ultra-rapid formulation of insulin lispro, an analogue of human insulin, using 2 excipients (treprostinil and citrate) to accelerate absorption, resulting in faster action and earlier glucose lowering than Humalog
Currently, 3.8 million people in the UK are diagnosed with diabetes. Up to 1 million people have type 2 diabetes that is yet to be diagnosed, so the total is estimated to be 4.7 million people at present. This represents 7% of the UK population (1 in every 15 people) having diabetes (diagnosed and undiagnosed). 10% have type 1 diabetes [5]. Incidence is increasing by about 4% each year, particularly in children under five, with a 5% increase each year in this age group [6].
Type 1 and 2 diabetes mellitus in adults
Subcutaneous

Trial or other data

Oct 18Two PIII trials demonstrated that Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog® (insulin lispro) and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes [4].
Dec 17PIII trials PRONTO-T1D and PRONTO-T2D are due to complete collecting primary outcome data in Sep 19 and Feb 19, respectively [3].
Jun 17Eli Lilly initiates the PIII PRONTO-T2D trial to evaluate the non-inferiority of ultra rapid formulation of insulin lispro to insulin lispro on glycaemic control in patients with type 2 diabetes mellitus, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin glargine or insulin degludec for 26 weeks (NCT03214380). The randomised, double-blind trial is enrolling approximately 670 patients [2].
May 17Eli Lilly initiates the PIII PRONTO-T1D trial to compare the safety and efficacy of ultra rapid formulation of insulin lispro, to insulin lispro, with an open-label postprandial LY 900014 treatment group, in combination with insulin glargine or insulin degludec, in patients with type 1 diabetes mellitus (NCT03214367). Assessment of the change in HbA1c is the defined primary endpoint of the trial. The randomised, double-blind trial intends to enrol approximately 1,567 patients from sites globally [2].

Evidence based evaluations