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Dr. Tim Heise
CSO
Tim is the Co-founder and CSO of Profil. He is your contact partner, among others, for the following areas:
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Insulin analogues
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Pharmacodynamics
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Clinical development consulting services
Short Bio
Tim has more than 25 years of experience in both clinical research and clinical care in diabetes and obesity. He has published well over 250 scientific papers and reviews with a focus on the pharmacology of insulin and anti-diabetic drugs. Dr. Heise is a member of the Editorial Board for Diabetes, Obesity and Metabolism and he takes a strong interest in evidence-based medicine.
Publications
Here are Tim's recent publications:
- Bianzano S, Schepers C, Wolff M, Heise T, Plum-Moerschel L. 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. Exp Clin Endocrinol Diabetes. 2022 Dec;130(12):773-782. doi: 10.1055/a-1932-3136. Epub 2022 Nov 7. PMID: 36343645; PMCID: PMC9811530.
- Eckstein ML, Aberer F, Dobler FJR, Aziz F, Heise T, Sourij H, Moser O. Association of HbA1c with VO2max in Individuals with Type 1 Diabetes: A Systematic Review and Meta-Analysis. Metabolites. 2022 Oct 24;12(11):1017. doi: 10.3390/metabo12111017. PMID: 36355100; PMCID: PMC9697838.
- Bianzano S, Nordaby M, Plum-Mörschel L, Peil B, Heise T. 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. Diabetes Obes Metab. 2023 Mar;25(3):832-843. doi: 10.1111/dom.14932. Epub 2022 Dec 22. PMID: 36478142; PMCID: PMC10107759.
- Heise T, Chien J, Beals JM, Benson C, Klein O, Moyers JS, Haupt A, Pratt EJ. Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. Diabetes Obes Metab. 2023 Apr;25(4):1080-1090. doi: 10.1111/dom.14956. Epub 2023 Jan 9. PMID: 36541037.
- Andersen G, Eloy R, Famulla S, Heise T, Meiffren G, Seroussi C, Gaudier M, Mégret C, Chan YP, Soula O, Riddle M. A co-formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes. Diabetes Obes Metab. 2023 May;25(5):1241-1248. doi: 10.1111/dom.14972. Epub 2023 Jan 31. PMID: 36633505.
- Heise T, Plum-Mörschel L, Zijlstra E. Oral insulin: A history of ambition, failure and data torturing. Diabetes Obes Metab. 2023 Apr;25(4):940-942. doi: 10.1111/dom.14984. Epub 2023 Feb 8. PMID: 36692379.
- Heise T, DeVries JH, Urva S, Li J, Pratt EJ, Thomas MK, Mather KJ, Karanikas CA, Dunn J, Haupt A, Milicevic Z, Coskun T. Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. Diabetes Care. 2023 May 1;46(5):998-1004. doi: 10.2337/dc22-1710. PMID: 36857477; PMCID: PMC10154650.
- Chen W, Lu J, Plum-Mörschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21. PMID: 37735841.
- Hövelmann U, Engberg S, Heise T, Kristensen NR, Nørgreen L, Zijlstra E, Ribel-Madsen R. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 1 diabetes. Diabetes Obes Metab. 2024 May;26(5):1941-1949. doi: 10.1111/dom.15510. Epub 2024 Feb 20. PMID: 38379002.
- Ambery P, Zajac G, Almquist J, Prothon S, Astbury C, Brown MN, Nemes S, Nsabimana J, Edman K, Öberg L, Lepistö M, Edenro G, Dillmann I, Mitra S, Belfield G, Keen C, Heise T. The effect of AZD9567 vs. prednisolone on glycaemic control in patients with type 2 diabetes mellitus: Results from a phase 2a clinical trial. Br J Clin Pharmacol. 2024 Aug;90(8):1921-1931. doi: 10.1111/bcp.16082. Epub 2024 May 1. PMID: 38690606.
- Mather KJ, Mari A, Heise T, DeVries JH, Hua M, Urva S, Coskun T, Haupt A, Heine RJ, Pratt E, Thomas MK, Milicevic Z. Effects of Tirzepatide vs Semaglutide on β-Cell Function, Insulin Sensitivity, and Glucose Control During a Meal Test. J Clin Endocrinol Metab. 2024 Nov 18;109(12):3046-3054. doi: 10.1210/clinem/dgae319. PMID: 38795393.
- Heise T, Andersen G, Pratt EJ, Leohr J, Fukuda T, Wang Q, Kazda C, Bue-Valleskey JM, Bergenstal RM. Frequency and Severity of Hypoglycemia Under Conditions of Increased Hypoglycemic Risk with Insulin Efsitora Alfa Versus Insulin Glargine Treatment in Participants with Type 2 Diabetes. Diabetes Ther. 2024 Aug;15(8):1785-1797. doi: 10.1007/s13300-024-01605-7. Epub 2024 Jun 22. PMID: 38907935; PMCID: PMC11263308.
- Andersen G, Eloy R, Heise T, Gaudier M, Mégret C, Seroussi C, Chan YP, Soula O, Riddle M, DeVries JH. ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes. Diabetes Obes Metab. 2024 Oct;26(10):4639-4645. doi: 10.1111/dom.15827. Epub 2024 Aug 7. PMID: 39109464.
- DeVries JH, Heckermann S, Heise T. Absence of a glucose-lowering effect in glucose clamp procedures with a long-acting insulin analogue. Diabetes Obes Metab. 2024 Dec;26(12):6067-6069. doi: 10.1111/dom.15939. Epub 2024 Sep 12. PMID: 39267247.
- Mather KJ, Mari A, Weerakkody G, Heise T, DeVries JH, Urva S, Coskun T, Milicevic Z, Haupt A, Thomas MK. Greater improvement in insulin sensitivity per unit weight loss associated with tirzepatide versus semaglutide: An exploratory analysis. Diabetes Obes Metab. 2025 Mar;27(3):1507-1514. doi: 10.1111/dom.16159. Epub 2025 Jan 6. PMID: 39762971.
- DeVries JH, Heise T. Once-Weekly Insulins. Diabetes Technol Ther. 2025 Jul;27(7):503-510. doi: 10.1089/dia.2024.0653. Epub 2025 Feb 6. PMID: 39911031.
- Heise T, DeVries JH. Biosimilar insulins: Narrative review of the regulatory framework and registration studies. Diabetes Obes Metab. 2025 Jul;27 Suppl 5(Suppl 5):16-23. doi: 10.1111/dom.16320. Epub 2025 Mar 16. PMID: 40091442; PMCID: PMC12169082.
- Leohr J, Klein O, Heise T, Zijlstra E, Bue-Valleskey JM, Suriyapperuma S, Jarrett R, James D, Case M, Waters D, Pratt E, Linnebjerg H. Characterisation of steady-state pharmacokinetics and glucodynamics of once-weekly insulin efsitora alfa in individuals with type 2 diabetes. Diabetes Obes Metab. 2026 May;28(5):4010-4018. doi: 10.1111/dom.70585. Epub 2026 Feb 23. PMID: 41725424; PMCID: PMC13071231.
- Brændholt Olsen M, Griffin J, Hövelmann U, Macura S, Fredsted Hagen B, Hesse D, Heise T. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials. Diabetes Obes Metab. 2026 Jul;28(7):5915-5925. doi: 10.1111/dom.70753. Epub 2026 Apr 22. PMID: 42017294; PMCID: PMC13243934.
- Heise T, Zijlstra E, Mari A, Roell WC, Mather KJ, Haupt A, Flevaris P, Liao R, Chua L, Harris C, Pratt EJ. Insulin Sensitivity and Beta Cell Function With Macupatide Alone or With Dulaglutide in Type 2 Diabetes: A Phase 1b, Randomised Controlled Trial. Diabetes Obes Metab. 2026 Aug;28(8):7196-7206. doi: 10.1111/dom.70863. Epub 2026 Jun 2. PMID: 42229460; PMCID: PMC13341334.
- Bianzano S, Heise T, Jungnik A, Schepers C, Schölch C, Gräfe-Mody U. Safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of BI 187004, an inhibitor of 11beta-hydroxysteroid dehydrogenase-1, in healthy male volunteers with overweight or obesity. Clin Diabetes Endocrinol. 2021 Aug 15;7(1):16. doi: 10.1186/s40842-021-00130-x. PMID: 34391480; PMCID: PMC8364686.
- Grant M, Heise T, Baughman R. Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2022 Mar;61(3):413-422. doi: 10.1007/s40262-021-01084-0. Epub 2021 Nov 13. PMID: 34773608; PMCID: PMC8891188.
- Heise T. Novel Drugs for Diabetes Therapy. Handb Exp Pharmacol. 2022;274:415-438. doi: 10.1007/164_2021_574. PMID: 35112236.
- Heise T, Mari A, DeVries JH, Urva S, Li J, Pratt EJ, Coskun T, Thomas MK, Mather KJ, Haupt A, Milicevic Z. Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):418-429. doi: 10.1016/S2213-8587(22)00085-7. Epub 2022 Apr 22. PMID: 35468322.
- Heise T, Piras de Oliveira C, Juneja R, Ribeiro A, Chigutsa F, Blevins T. What is the value of faster acting prandial insulin? Focus on ultra rapid lispro. Diabetes Obes Metab. 2022 Sep;24(9):1689-1701. doi: 10.1111/dom.14773. Epub 2022 Jun 15. PMID: 35593434; PMCID: PMC9540401.
- Heise T
The future of insulin therapy.
DIABETES RES CLIN PRACT 2021 Apr 16; 175:108820. doi:10.1016/j.diabres.2021.108820. Online ahead of print - Moser O, Riddell MC, Eckstein ML, Adolfsson P, Rabasa-Lhoret R, van den Boom L, Gillard P, Norgaard K, Oliver NS, Zaharieva DP, Battelino T, de Beaufort C, Bergenstal RM, Buckingham B, Cengiz E, Deeb A, Heise T, Heller S, Kowalski AJ, Leelarathna L, Mathieu C, Stettler C, Tauschmann M, Thabit H, Wilmot EG, Sourij H, Smart CE, Jacobs PG, Bracken RM, Mader JK., Glucose monitoring for exercise using continuous glucose monitoring: should sex and prandial state be additional requirements? Reply to Yardley JE and Sigal RJ (letter)
DIABETOLOGIA 64: 935-938, 2021 - Benesch C, Kuhlenkötter M, Nosek L, Heise T.
New Clamp-PID Algorithm for automated glucose clamps improves clamp quality.
J Diabetes Sci Technol 2021 Feb 10. doi: 10.1177/1932296821991514 -
Lind M, Olafsdottir AF, Hirsch IB, Bolinder J, Dahlqvist S, Pivodic A, Hellman J, Wijkman M, Schwarcz E, Albrektsson H, Heise T, Polonsky W. Sustained intensive treatment and long-term effects on HbA1c reduction (SILVER Study) by CGM in people with type 1 diabetes treated with MDI.
DIABETES CARE 44: 141-149, 2021 -
Herbrand T, Coester HV, Sansone R, Fischer A, Heiss C, Heise T, Kelm M, DeVries HJ. Improving the assessment of flow-mediated dilation through detection of peak time in healthy subjects and subjects with type 2 diabetes.
ANGIOLOGY 2020 Dec 30. doi: 10.1177/0003319720984884. Online ahead of print -
Andersen G, Meiffren G, Famulla S, Heise T, Ranson A, Seroussi C, Eloy R, Gaudier M, Charvet R, Chan Y-P, Soula O, DeVries JH.
ADO09, a co-formulation of the amylin-analog pramlintide and the insulin analog A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes (T1D).
DIABETES OBES METAB 2020 Dec 18. doi: 10.1111/dom.14302. Online ahead of print. -
Lind M, Olafsdottir AF, Hirsch IB, Bolinder J, Dahlqvist S, Pivodic A, Hellman J, Wijkman M, Schwarcz E, Albrektsson H, Heise T, Polonsky W.
Sustained intensive treatment and long-term effects on HbA1c reduction (SILVER Study) by CGM in people with type 1 diabetes treated with MDI.
DIABETES CARE 44: 141-149, 2021 -
Andersen G, Meiffren G, Famulla S, Heise T, Ranson A, Seroussi C, Eloy R, Gaudier M, Charvet R, Chan Y-P, Soula O, DeVries JH.
ADO09, a co-formulation of the amylin-analog pramlintide and the insulin analog A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes (T1D).
DIABETES OBES METAB 2020 Dec 18. doi: 10.1111/dom.14302. Online ahead of print. -
Eckstein ML. Boufleur Farinha J, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Müller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O.
Differences in physiological responses to cardiopulmonary exercise testing in adults with and without type 1 diabetes: A pooled analysis.
DIABETES CARE 2020 Nov 12. doi: 10.2337/dc20-1496. Online ahead of print. -
Gruchala A, Cypryk K, Schliess F, Bobeff K, Heise T, Gurdala M, Szadkowsky A, Mianowska B.
Pains and needs of patients with type 2 diabetes as targets for novel technologies.
CLINICAL DIABETOLOGY 2020, 9. doi: 10.5603/DK.2020.0052 -
Stegbauer C, Falivena C, Moreno A, Hentschel A, Rosenmöller M, Heise T, Szecsenyi J, Schliess F.
Costs and its drivers for diabetes mellitus type 2 patients in France and Germany: a systematic review of economic studies.
BMC HEALTH SERVICES RESEARCH 2020 Nov 16; 20(1): 1043. -
Moser O, Riddell MC, Eckstein ML, Adolfsson P, Rabasa-Lhoret R, van den Boom L, Gillard P, Norgaard K, Oliver NS, Zaharieva DP, Battelino T, de Beaufort C, Bergenstal RM, Buckingham B, Cengiz E, Deeb A, Heise T, Heller S, Kowalski A, Leelarathna L, Mathieu C, Stettler C, Tauschmann M, Thabit H, Wilmot EG, Sourij H, Smart CE, Jacobs PG, Bracken RM, Mader JK.
Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA).
DIABETOLOGIA 2020 Oct 13. doi: 10.1007/s00125-020-05263-9. Online ahead of print - Seyed Ahmadi S, Westman K, Pivodic A, Olafsdottir AF, Dahlqvist S, Hirsch IB, Hellman J, Ekelund M, Heise T, Polonsky W, Wijkman M, Schwarcz E, Lind M.
The association between HbA1c and time in hypoglycemia during CGM and self-monitoring of blood glucose in people with type 1 diabetes and multiple daily insulin injections: A randomized clinical trial (GOLD-4).
DIABETES CARE 2020 Jul 8. doi: 10.2337/dc-19-2606. Online ahead of print - Leohr J, Dellva MA, Coutant DE, LaBell E, Heise T, Andersen G, Zijlstra E, Hermanski L, Nosek L, Linnebjerg H.
Pharmacokinetics and glucodynamics of ultra rapid lispro (URLi) versus Humalog (lispro) in patients with type 2 diabetes mellitus: A phase I randomised, crossover study.
Clin Pharmacokinet 2020 May 29. doi: 10.1007/s40262-020-00901-2. Online ahead of print - Heise T, Linnebjerg H, Coutant D, LaBell E, Zijlstra E, Kapitza C, Bue-Valleskey J, Zhang Q, Dellva MA, Leohr J.
Ultra rapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogs: A Phase 1 randomized, crossover study.
DIABETES OBES METAB 2020 May 21. doi: 10.1111/dom.14094. Online ahead of print
Browse Profil's list of publications to see our other publications.
Selected Achievements and Work Experience
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2025 - today |
CSO Profil Institute Holding |
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2016 - today |
Lead Scientist and chair of the Board of Directors of Profil. |
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1999 - 2016 |
Co-founder and CEO Science of Profil. Principal Investigator of several hundred challenging early phase studies of experimental diabetes treatments; in particular pharmacodynamic / pharmacokinetic assessments performed with the glucose clamp technique |
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2002 |
Co-founder of DIEM, Institute for Evidence-Based Medicine in Cologne, Germany |
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2000 - 2002 |
Clinical job on the side at the Department for Internal Medicine, St. Franziskus Hospital Cologne (Director: Prof. P.T. Sawicki) for the outpatient care of diabetic patients |
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1991 - 1999 |
Scientific Associate, Clinic of Metabolic Diseases and Nutrition, Heinrich-Heine-University Düsseldorf, WHO Collaborating Center for Diabetes. Occupation at the Diabetes ward and the Endocrinology/Rheumatology ward, the out-patient clinics for diabetes, diabetic foot problems, diabetic late complications, and obesity, and at the Intensive Care Unit. In charge of numerous GCP-studies concerning insulin resistance, hypertension, obesity, and pharmacokinetic and –dynamic properties of novel insulin preparations, insulin administration forms and antidiabetic drugs |






