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Pharmacokinetic and Pharmacodynamic Characteristics Diabetes Care Volume 41, March 2018 531 Ulrike Hovelmann,¨ 1 Britta Væver Bysted,2 Pharmacokinetic and Ulrik Mouritzen,2 Francesca Macchi,2 Daniela Lamers,1 Birgit Kronshage,1 Pharmacodynamic Characteristics Daniel´ Vega Møller,2 and Tim Heise1 of Dasiglucagon, a Novel Soluble and Stable Glucagon Analog Diabetes Care 2018;41:531–537 | https://doi.org/10.2337/dc17-1402 OBJECTIVE Treatment of severe hypoglycemia outside of the hospital setting is limited to glu- cagon formulations requiring reconstitution before use, which may lead to erroneous or delayed glucagon administration. We compared the pharmacokinetic (PK) and EMERGING TECHNOLOGIES AND THERAPEUTICS pharmacodynamic (PD) characteristics and safety and tolerability of different doses of dasiglucagon, a novel soluble glucagon analog, with approved pediatric and full doses of GlucaGen in insulin-induced hypoglycemia in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS In this single-center, randomized, double-blind trial, 58 patients with type 1 diabetes received single subcutaneous injections of 0.1, 0.3, 0.6, or 1.0 mg dasiglucagon or 0.5 or 1.0 mg GlucaGen in a state of hypoglycemia (blood glucose target 55 mg/dL) induced by an intravenous insulin infusion. RESULTS Dasiglucagon demonstrated a dose-dependent and rapid increase in plasma concen- trations, reaching a maximum at ∼35 min with a half-life of ∼0.5 h. Dasiglucagon rapidly increased plasma glucose (PG) by ‡20 mg/dL (9–14 min) to PG ‡70 mg/dL (within 6–10 min), similar to GlucaGen, but with a longer-lasting and greater effect on PG. All patients on both treatments reached these end points within 30 min (pre- 1Profil, Neuss, Germany defined success criteria). Both treatments were well tolerated. Nausea was the most 2Zealand Pharma A/S, Glostrup, Denmark frequent adverse event, occurring at a similar rate (44–56%). Corresponding author: Ulrike Hovelmann,¨ ulrike .hoevelmann@profil.com. CONCLUSIONS Received 31 July 2017 and accepted 22 Novem- Dasiglucagon was well tolerated and showed an early PD response similar to that of ber 2017. GlucaGen at corresponding doses, suggesting comparable clinical effects of the two Clinical trial reg. no. NCT02660008, clinicaltrials glucagon formulations. Dasiglucagon has the potential to become an effective and .gov. reliable rescue treatment for severe hypoglycemia in a ready-to-use pen. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/ suppl/doi:10.2337/dc17-1402/-/DC1. Currently available glucagon formulations for rescue treatment of severe hypoglycemia This article is featured in a podcast available at require reconstitution of dry powder in aqueous solution immediately prior to each use. http://www.diabetesjournals.org/content/ The process of reconstitution and delivery is complex and requires adequate education of diabetes-core-update-podcasts. families and caregivers, which is not ideal for an emergency drug. Despite training, the © 2017 by the American Diabetes Association. reconstitution process could still lead to erroneous or delayed administration of glucagon, Readers may use this article as long as the work is properly cited, the use is educational and not at least when used by medical nonprofessionals in stressful emergency situations (1,2). for profit, and the work is not altered. More infor- Native glucagon is a highly unstable peptide prone to spontaneous polymerization mation is available at http://www.diabetesjournals and formation of amyloid-like fibrils, resulting in the product becoming unusable within .org/content/license. 532 PK/PD of Novel Stable Liquid Glucagon Analog Diabetes Care Volume 41, March 2018 1 day of reconstitution (3). Instructions with those of GlucaGen different dose screening visit, a screening visit (3–30 days for commercially available glucagon allow ranges in insulin-induced hypoglycemia in before the first dosing visit), one dosing only immediate usage after reconstitution patients with type 1 diabetes. visit for group 1 and two dosing visits for (4,5). Stable liquid formulations of a glu- groups 2–4 separated by 7 6 3days cagon analog in a ready-to-use injection RESEARCH DESIGN AND METHODS washout, and a follow-up visit (21 6 3 device would offer major clinical advan- Trial Design days after the last dosing visit). In group tages, such as speed and ease of use for This was a single-center (Profil, Neuss, 1, patients received a single s.c. dose of rescue treatment in patients experienc- Germany), randomized, double-blind trial 0.1 mg dasiglucagon (1 mg/mL, liquid for- ing severe hypoglycemia. Furthermore, a in patients with type 1 diabetes. The trial mulation in prefilled syringes; Zealand simplified glucagon application might re- included four groups of patients, with the Pharma, Copenhagen, Denmark) or a sin- duce the fear of hypoglycemic events, first eight patients (group 1) randomly gle s.c. dose of lyophilized glucagon (1 mg which is sometimes the underlying source allocated (3:1) to either a mini-dose of for reconstitution, GlucaGen; Novo Nor- of suboptimal glycemic control in patients dasiglucagon (0.1 mg) (6 patients) or a full disk, Copenhagen, Denmark). In groups with diabetes, resulting in an increased dose (1.0 mg) of GlucaGen (2 patients). 2–4, patients were administered three risk for complications (6). Subsequent patients were randomly allo- different single s.c. doses for dasigluca- Bihormonal artificial pancreas systems cated to one of the three other treatment gon and two different single doses for might be another promising option for a groups (groups 2–4, with 16 patients in GlucaGen. Both treatments were received stable glucagon analog. Maintaining each group) and received a single dose in a randomized sequence. euglycemia in artificial pancreas settings of 0.3 mg (group 2), 0.6 mg (group 3), or For maintenance of double blinding, is challenging because of the slow onset 1.0 mg (group 4) dasiglucagon and, in a the appropriate dose/volume was trans- and the relative long duration of action cross-over fashion, a single pediatric dose ferred from the prefilled syringes (dasi- of subcutaneous (s.c.) prandial insulins, of GlucaGen of 0.5 mg (group 2) or full dose glucagon) or from the vial filled with so a more aggressive insulin titration could of 1.0 mg (groups 3 and 4) (Supplementary freshly reconstituted solution (GlucaGen) easily lead to hypoglycemia. Hypoglycemia Fig. 2). (Pediatric dose of GlucaGen has into 1-mL disposable syringes with at- could be avoided with an s.c. glucagon for- been approved for children ,25 kg or tached 27 G needles (Becton Dickinson) mulation in the bihormonal artificial pan- younger than 6–8 years of age.) by staff not otherwise involved in trial pro- creas systems, but currently available The trial protocol was reviewed and cedures. Both trial products were adminis- glucagon formulations are only stable for approved by the local health authority tered by s.c. injection into a lifted skinfold 24 h. Undoubtedly, a glucagon analog with (Bundesinstitut fur¨ Arzneimittel und Medizin- of the abdominal wall around the umbili- longer stability at body temperature would produkte) and by an independent ethics cus. Basal insulin was continued as usual substantially increase the feasibility of bi- committee (Arztekammer¨ Nordrhein). The during the dosing day, whereas short-acting hormonal pump delivery devices (7–14). trial was performed in accordance with the insulin was replaced by insulin glulisine Dasiglucagon is a novel stable peptide Declaration of Helsinki and the Interna- (Apidra; Sanofi Deutschland GmbH, Frankfurt, analog of human glucagon in an aqueous tional Conference on Harmonization and Germany) from 12 h prior to each dosing solution at neutral pH, consisting of 29 Good Clinical Practice. Written informed onwards. Patients using continuous s.c. in- amino acids with 7 amino acid substitutions consent was obtained before initiation of sulin infusion continued their basal insulin relative to native glucagon. (Dasiglucagon any trial-related activities. The trial was reg- rate during the experiment. is the proposed international nonpro- istered at ClinicalTrials.gov (trial identifier: Patients attended the clinical site in the prietary name.) These amino acid substi- NCT02660008). morning after an overnight fast and par- tutions result in improved physical and ticipated in a manual hypoglycemic clamp Participants chemical stability compared with cur- Eligible adults were aged between 18 and procedure that started with a variable in- rently available glucagon formulations 50 years, both inclusive, had been diag- fusion of intravenous (i.v.) insulin glulisine (Supplementary Fig. 1). nosed with type 1 diabetes per American (15 units Apidra dissolved in 49 mL saline ’ Dasiglucagon can be dissolved to at Diabetes Association criteria, and had been and 1 mL of the patient s own blood to least 20 mg/mL at pH 7.0 in the presence treated with insulin for $12 months (15). prevent insulin adherence to tubing mate- and absence of preservatives (m-cresol). Participants were required to have a gly- rial), targeting a blood glucose level of 6 Ongoing stability studies show stability at cosylated hemoglobin (HbA ) ,8.5% 55 mg/dL 10%, corresponding to a 1c 6 40°C under shaking conditions with absence (69.4 mmol/mol) and body weight be- plasma glucose (PG) level of 62 mg/dL fi fl fl of brillation in a Thio avin T uorescence tween 60 and 90 kg (both inclusive). Pa- 10% (3.4 mmol/L) prior to dose adminis- m , assay (samples containing 40 mol/L tients were excluded if they had clinically tration. If PG levels decreased 56 mg/dL fl Thio avin T, excitation 450 nm, and emis- significant concomitant diseases, had clin- (3.1 mmol/L) prior to dosing, i.v. glucose sion 485 nm) for at least 7 days, while na- ically significant abnormal values in clini- was infused and the run-in period ex- fi tive glucagon in the same assay brillated cal laboratory screening tests, were tended until the target range was estab- within 3 h, enabling the use of dasiglucagon habitual smokers, or had any other con- lished for at least 10 min before dose in a ready-to-use rescue device and poten- dition conflicting with trial participation administration.
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