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Article ; Online: Oral insulin: A history of ambition, failure and data torturing.

Heise, Tim / Plum-Mörschel, Leona / Zijlstra, Eric

2023 Volume 25, Issue 4, Page(s) 940–942

MeSH term(s)	Humans ; Insulin ; Torture ; Insulin, Regular, Human
Chemical Substances	Insulin ; Insulin, Regular, Human
Language	English
Publishing date	2023-02-08
Publishing country	England
Document type	Journal Article
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14984
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Article ; Online: Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus.

Plum-Mörschel, Leona / Andersen, Lizette Ravn / Hansen, Solvejg / Hövelmann, Ulrike / Krawietz, Patricia / Kristensen, Niels Rode / Lehrskov, Lars Lang / Haahr, Hanne

Clinical drug investigation

2023 Volume 43, Issue 2, Page(s) 119–127

MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/drug therapy ; Arm ; Thigh ; Abdomen ; Injections, Subcutaneous ; Glucose/therapeutic use ; Hypoglycemic Agents
Chemical Substances	insulin icodec ; Glucose (IY9XDZ35W2) ; Hypoglycemic Agents
Language	English
Publishing date	2023-01-11
Publishing country	New Zealand
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	1220136-4
ISSN	1179-1918 ; 0114-2402 ; 1173-2563
ISSN (online)	1179-1918
ISSN	0114-2402 ; 1173-2563
DOI	10.1007/s40261-022-01243-6
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Zs.A 2807: Show issues

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Article ; Online: Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study.

Handy, Consuelo / Chaudhry, Mohamed Sabih / Qureshi, Muhammad Rafaqat Ali / Love, Bradley / Shillingford, John / Plum-Mörschel, Leona / Zijlstra, Eric

Journal of diabetes science and technology

2023 , Page(s) 19322968231170242

Abstract: Background: A noninvasive, wearable continuous glucose monitor would be a major advancement in diabetes therapy. This trial investigated a novel noninvasive glucose monitor which analyzes spectral variations in radio frequency/microwave signals ... ...

Abstract	Background: A noninvasive, wearable continuous glucose monitor would be a major advancement in diabetes therapy. This trial investigated a novel noninvasive glucose monitor which analyzes spectral variations in radio frequency/microwave signals reflected from the wrist. Methods: A single-arm, open-label, experimental study compared glucose values from a prototype investigational device with laboratory glucose measurements from venous blood samples (Super GL Glucose Analyzer, Dr. Müller Gerätebau GmbH) at varying levels of glycemia. The study included 29 male participants with type 1 diabetes (age range = 19-56 years). The study comprised three stages with the following aims: (1) demonstrate initial proof-of-principle, (2) test an improved device design, and (3) test performance on two consecutive days without device recalibration. The co-primary endpoints in all trial stages were median and mean absolute relative difference (ARD) calculated across all data points. Results: In stage 1, the median and mean ARDs were 30% and 46%, respectively. Stage 2 produced marked performance improvements with a median and mean ARD of 22% and 28%, respectively. Stage 3 showed that, without recalibration, the device performed as well as the initial prototype (stage 1) with a median and mean ARD of 35% and 44%, respectively. Conclusion: This proof-of-concept study shows that a novel noninvasive continuous glucose monitor was capable of detecting glucose levels. Furthermore, the ARD results are comparable to first models of commercially available minimally invasive products without the need to insert a needle. The prototype has been further developed and is being tested in subsequent studies. Trial registration number: NCT05023798.
Language	English
Publishing date	2023-04-27
Publishing country	United States
Document type	Journal Article
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968231170242
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Article ; Online: Selective Inhibition of 11beta-Hydroxysteroiddehydrogenase-1 with BI 187004 in Patients with Type 2 Diabetes and Overweight or Obesity: Safety, Pharmacokinetics, and Pharmacodynamics After Multiple Dosing Over 14 Days.

Bianzano, Susanna / Schepers, Cornelia / Wolff, Michael / Heise, Tim / Plum-Moerschel, Leona

Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association

2022

Abstract: Objective: To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with the selective 11beta-hydroxysteroid dehydrogenase-1 (11beta-HSD1) inhibitor BI 187004 in male and female patients with type 2 diabetes and overweight or ... ...

Abstract	Objective: To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with the selective 11beta-hydroxysteroid dehydrogenase-1 (11beta-HSD1) inhibitor BI 187004 in male and female patients with type 2 diabetes and overweight or obesity. Methods: Randomized, double-blind, parallel-group, placebo-controlled multiple rising dose study, with 10-360 mg BI 187004 once daily over 14 days in 71 patients. Assessments included 11beta-HSD1 inhibition in the liver and subcutaneous adipose tissue ex vivo (clinical trial registry number NCT01874483). Results: BI 187004 was well tolerated and safe in all tested dose groups. The incidence of drug-related adverse events was 51.8% (n=29) for BI 187004 and 35.7% (n=5) for placebo. There were no clinically relevant deviations in laboratory or electrocardiogram parameters besides one patient on 360 mg discontinuing treatment due to moderate supraventricular tachycardia.BI 187004 was rapidly absorbed within 2 h; exposure increased non-proportionally. The oral clearance was low, apparent volume of distribution was moderate to large, and terminal half-life with 106-124 h was rather long. Urinary tetrahydrocortisol/tetrahydrocortisone ratio decreased, indicating liver 11beta-HSD1 inhibition. Median inhibition of 11beta-HSD1 in subcutaneous adipose tissue biopsies was 87.9-99.4% immediately after the second dose and 73.8-97.5% 24 h after the last dose of BI 187004. Conclusions: BI 187004 was safe and well tolerated over 14 days and could be dosed once daily. Targeted 11beta-HSD1 enzyme inhibition of≥80% could be shown for BI 187004 doses≥40 mg. This dose should be targeted in further studies to test blood glucose lowering in patients with type 2 diabetes and overweight or obesity.
Language	English
Publishing date	2022-11-07
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1225416-2
ISSN	1439-3646 ; 0947-7349
ISSN (online)	1439-3646
ISSN	0947-7349
DOI	10.1055/a-1932-3136
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Article ; Online: Safety, tolerability, pharmacodynamics and pharmacokinetics following once-daily doses of BI 187004, an inhibitor of 11 beta-hydroxysteroid dehydrogenase-1, over 28 days in patients with type 2 diabetes mellitus and overweight or obesity.

Bianzano, Susanna / Nordaby, Matias / Plum-Mörschel, Leona / Peil, Barbara / Heise, Tim

Diabetes, obesity & metabolism

2022 Volume 25, Issue 3, Page(s) 832–843

Abstract: Aims: To study the oral 11 beta-hydroxysteroid dehydrogenase-1 (11β-HSD1) inhibitor BI 187004 (NCT02150824), as monotherapy and in combination with metformin, versus placebo in patients with type 2 diabetes mellitus (T2DM) affected by overweight or ... ...

Abstract	Aims: To study the oral 11 beta-hydroxysteroid dehydrogenase-1 (11β-HSD1) inhibitor BI 187004 (NCT02150824), as monotherapy and in combination with metformin, versus placebo in patients with type 2 diabetes mellitus (T2DM) affected by overweight or obesity. Materials and methods: This Phase II, randomized controlled trial investigated multiple rising doses of BI 187004 as monotherapy (Arm 1: 20, 80 or 240 mg) and in combination with metformin (Arm 2: 240 mg), in adults with T2DM and a body mass index of 28-40 kg/m Results: In total, 103 patients (Arm 1: n = 62, Arm 2: n = 41) were included in this study. BI 187004 was rapidly absorbed and exposure increased approximately dose-dependently. Target engagement of 11β-HSD1 was observed with near-full inhibition of 11β-HSD1 in the liver [decreased (5α-tetrahydrocortisol + 5β-tetrahydrocortisol)/tetrahydrocortisone ratio]; hypothalamic-pituitary-adrenal axis activation was also seen (increased total urinary corticosteroids). No clinically relevant changes from baseline with BI 187004 treatment were observed for bodyweight or meal tolerance test parameters, or in most efficacy endpoints testing glucose and lipid metabolism; a significant increase was observed in weighted mean plasma glucose (p < .05 for 80 and 240 mg BI 187004) but not fasting plasma glucose. Drug-related adverse events were reported for 14 patients (22.6%) in Arm 1 and 10 patients (24.4%) in Arm 2, most frequently headache, diarrhoea, flushing and dizziness. A dose-dependent increase in heart rate was seen with BI 187004 treatment. Conclusions: BI 187004 was generally well tolerated in patients with T2DM. Despite complete 11β-HSD1 inhibition, no clinically relevant effects were observed with BI 187004.
MeSH term(s)	Adult ; Humans ; 11-beta-Hydroxysteroid Dehydrogenase Type 1/metabolism ; Blood Glucose ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Hypothalamo-Hypophyseal System/metabolism ; Metformin/adverse effects ; Obesity/complications ; Overweight/complications ; Pituitary-Adrenal System/metabolism ; Tetrahydrocortisol/therapeutic use
Chemical Substances	11-beta-Hydroxysteroid Dehydrogenase Type 1 (EC 1.1.1.146) ; Blood Glucose ; Metformin (9100L32L2N) ; Tetrahydrocortisol (7P2O6MFN8O)
Language	English
Publishing date	2022-12-22
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14932
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Article ; Online: Editorial: evolution of GLP-1 receptor agonists as pharmacotherapy for NASH beyond diabetes mellitus and obesity - authors' reply.

Flint, Anne / Andersen, Grit / Hockings, Paul / Plum-Mörschel, Leona / Loomba, Rohit

Alimentary pharmacology & therapeutics

2021 Volume 54, Issue 11-12, Page(s) 1498

MeSH term(s)	Diabetes Mellitus ; Glucagon-Like Peptide-1 Receptor ; Humans ; Hypoglycemic Agents/therapeutic use ; Non-alcoholic Fatty Liver Disease/drug therapy ; Obesity/complications ; Obesity/drug therapy
Chemical Substances	Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents
Language	English
Publishing date	2021-11-05
Publishing country	England
Document type	Editorial ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.16669
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Article ; Online: Effect of upper gastrointestinal disease on the pharmacokinetics of oral semaglutide in subjects with type 2 diabetes.

Meier, Juris J / Granhall, Charlotte / Hoevelmann, Ulrike / Navarria, Andrea / Plum-Moerschel, Leona / Ramesh, Chethana / Tannapfel, Andrea / Kapitza, Christoph

Diabetes, obesity & metabolism

2022 Volume 24, Issue 4, Page(s) 684–692

Abstract: Aim: To investigate whether upper gastrointestinal (GI) disease has any effect on the exposure of oral semaglutide, an important consideration given that its absorption occurs primarily in the stomach.: Materials and methods: In an open-label, ... ...

Abstract	Aim: To investigate whether upper gastrointestinal (GI) disease has any effect on the exposure of oral semaglutide, an important consideration given that its absorption occurs primarily in the stomach. Materials and methods: In an open-label, parallel-group trial (NCT02877355), subjects aged 18-80 years with type 2 diabetes with mild-to-moderate upper GI disease (N = 36; chronic gastritis [n = 5], gastroesophageal reflux disease [n = 8], and both [n = 23]) or without upper GI disease (N = 19) received oral semaglutide 3 mg once daily for 5 days, followed by 7 mg for 5 days. The primary and key supportive endpoints were the area under the semaglutide plasma concentration-time curve (AUC) from 0 to 24 hours after last trial product administration on day 10 (AUC Results: Semaglutide exposure was not statistically significantly different between subjects with and without upper GI disease. Estimated group ratios (subjects with/without upper GI disease) were 1.18 (95% confidence interval [CI], 0.80, 1.75) for AUC Conclusions: There was no significant difference in exposure to oral semaglutide in subjects with or without upper GI disease, hence no dose adjustment is required.
MeSH term(s)	Administration, Oral ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Diabetes Mellitus, Type 2/chemically induced ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Gastrointestinal Diseases/chemically induced ; Gastrointestinal Diseases/drug therapy ; Glucagon-Like Peptides ; Humans ; Hypoglycemic Agents ; Middle Aged ; Young Adult
Chemical Substances	Hypoglycemic Agents ; semaglutide (53AXN4NNHX) ; Glucagon-Like Peptides (62340-29-8)
Language	English
Publishing date	2022-01-17
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14632
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Article ; Online: Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US-licensed Humulin® R formulation in healthy subjects: Results from the RHINE-1 (Recombinant Human INsulin Equivalence-1) study.

Plum-Mörschel, Leona / Singh, Gursharan / Murugesan, Sundara Moorthi Nainar / Marwah, Ashwani / Panda, Jayanti / Loganathan, Subramanian / Athalye, Sandeep N

Diabetes, obesity & metabolism

2022 Volume 24, Issue 4, Page(s) 713–721

Abstract: Aim: To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects.: Materials and methods: ... ...

Abstract	Aim: To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects. Materials and methods: In this phase-1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin-R and Humulin-R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 12 hours (AUC Results: Equivalence was demonstrated between Biocon's Insulin-R and Humulin-R for the primary PK and PD endpoints. The 90% confidence intervals were within 80.00% to 125.00% limits. The PK and PD profiles were comparable. There were no significant differences in the safety profiles of the two treatments, and no serious adverse events were reported. Conclusion: PK and PD equivalence was demonstrated between Biocon's Insulin-R and Humulin-R in healthy subjects. Treatment with Biocon's Insulin-R and Humulin-R was well tolerated.
MeSH term(s)	Area Under Curve ; Biosimilar Pharmaceuticals/therapeutic use ; Cross-Over Studies ; Double-Blind Method ; Healthy Volunteers ; Humans ; Hypoglycemic Agents/adverse effects ; Insulin ; Insulin, Regular, Human ; Therapeutic Equivalency
Chemical Substances	Biosimilar Pharmaceuticals ; Hypoglycemic Agents ; Insulin ; Insulin, Regular, Human
Language	English
Publishing date	2022-01-28
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14635
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Article ; Online: Acute effects of linagliptin on intact and total glucagon-like peptide-1 and gastric inhibitory polypeptide levels in insulin-dependent type 2 diabetes patients with and without moderate renal impairment.

Meier, Juris J / Quast, Daniel R / Nauck, Michael A / Schenker, Nina / Deacon, Carolyn F / Holst, Jens J / Plum-Mörschel, Leona / Kapitza, Christoph

Diabetes, obesity & metabolism

2022 Volume 24, Issue 5, Page(s) 806–815

Abstract: Aims: To investigate the effect of renal impairment on incretin metabolism in patients with type 2 diabetes mellitus (T2DM) before and after treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin.: Materials and methods: Long- ... ...

Abstract	Aims: To investigate the effect of renal impairment on incretin metabolism in patients with type 2 diabetes mellitus (T2DM) before and after treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin. Materials and methods: Long-standing T2DM patients with normal (estimated glomerular filtration rate [eGFR] >90 mL/min/1.73m Results: Of 115 patients screened, 29 were analysed (15 [51.7%] with and 14 [48.3%] without renal impairment). Renal function differed significantly between the groups (101 ± 11 vs. 47 ± 13 mL/min/1.73m Conclusions: Treatment with linagliptin increases intact incretin levels in patients with T2DM. Impaired renal function does not compromise the effects of linagliptin on active or total incretin levels as well as on glucagon secretion. Thus, treatment with linagliptin is suitable for patients with T2DM, independently of renal function.
MeSH term(s)	Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/metabolism ; Gastric Inhibitory Polypeptide/metabolism ; Glucagon-Like Peptide 1/metabolism ; Humans ; Insulin/therapeutic use ; Linagliptin/therapeutic use
Chemical Substances	Blood Glucose ; Insulin ; Linagliptin (3X29ZEJ4R2) ; Gastric Inhibitory Polypeptide (59392-49-3) ; Glucagon-Like Peptide 1 (89750-14-1)
Language	English
Publishing date	2022-01-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14636
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Article ; Online: Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.

Pieber, Thomas R / Aronson, Ronnie / Hövelmann, Ulrike / Willard, Julie / Plum-Mörschel, Leona / Knudsen, Kim M / Bandak, Benedikte / Tehranchi, Ramin

Diabetes care

2022 Volume 44, Issue 6, Page(s) 1361–1367

Abstract: Objective: To evaluate the efficacy and safety of dasiglucagon, a ready-to-use, next-generation glucagon analog in aqueous formulation for subcutaneous dosing, for treatment of severe hypoglycemia in adults with type 1 diabetes.: Research design and ... ...

Abstract	Objective: To evaluate the efficacy and safety of dasiglucagon, a ready-to-use, next-generation glucagon analog in aqueous formulation for subcutaneous dosing, for treatment of severe hypoglycemia in adults with type 1 diabetes. Research design and methods: This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia. The primary end point was time to plasma glucose recovery, defined as an increase of ≥20 mg/dL from baseline without rescue intravenous glucose. The primary comparison was dasiglucagon versus placebo; reconstituted lyophilized glucagon was included as reference. Results: Median (95% CI) time to recovery was 10 (10, 10) minutes for dasiglucagon compared with 40 (30, 40) minutes for placebo (P < 0.001); the corresponding result for reconstituted glucagon was 12 (10, 12) minutes. In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%). Similar outcomes were observed for the other investigated time points at 10, 20, and 30 min after dosing. The most frequent adverse effects were nausea and vomiting, as expected with glucagon treatment. Conclusions: Dasiglucagon provided rapid and effective reversal of hypoglycemia in adults with type 1 diabetes, with safety and tolerability similar to those reported for reconstituted glucagon injection. The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia.
MeSH term(s)	Adult ; Blood Glucose ; Diabetes Mellitus, Type 2/drug therapy ; Double-Blind Method ; Glucagon/analogs & derivatives ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/drug therapy ; Hypoglycemic Agents/adverse effects ; Insulin/therapeutic use
Chemical Substances	Blood Glucose ; Hypoglycemic Agents ; Insulin ; dasiglucagon ; Glucagon (9007-92-5)
Language	English
Publishing date	2022-02-28
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc20-2995
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