Michael E. Trautmann, M.D.

Michael E. Trautmann, M.D.

Internist/Diabetologe DDG/Diabetology

Consulting for Pharmaceutical Industry,
CRO, Physicians, Clinic Trials

Fueerbarg 16a
D-22393 Hamburg
Germany

Phone: +49 40 60097132
Fax: +49 40 60097135
michael@trautmann-diabetes.de
www.trautmann-diabetes.de

Research in diabetes, obesity, metabolism

About

Michael E. Trautmann M.D. trained in Internal Medicine and Diabetology at the Universities Goettingen and Marburg, Germany, and Geneva, Switzerland.

His clinical research focused on diabetes treatment and endocrine tumors of the gut. In his laboratory intracellular mechanisms involved in controlling insulin release and cell differentiation of pancreatic beta cells were investigated. Already since 1987 he has been involved in research around Glucagon-like peptide-1 and its effects on insulin secretion.

In 1993, he joined Lilly Germany as Clinical Research Physician for Diabetes where he was responsible for the clinical development of insulin lispro (Humalog). From 1996 to 1998 he was Global Physician in the Endocrine Therapeutic Area in Indianapolis with responsibilities for early phase development of novel therapeutic approaches in the area of obesity and Type 2 diabetes treatment. Thereafter he moved to the new Lilly Research Laboratories in Hamburg and coordinated early phase clinical programs. He worked on several programs in the area of GLP-1. Under his leadership exenatide (Byetta and Bydureon) were approved as treatment for Diabetes in Europe, USA, and Japan. He retired from Lilly in 2011 as Senior Medical Fellow in the Lilly Diabetes Global Medical Team.

Michael Trautmann is member of several national and international associations for Diabetes and Endocrine Research and has authored numerous publications in this field.

Expertise

  • Drug development support for all phases of development:
  • Preclinical evaluation of molecules and mechanisms
    • Cell culture models for diabetes
    • Animal models
    • Selection of testing strategies
  • Drug Targets
    • Identifikation of suitable targets like enzymes, receptors and post-receptor signalling pathways
  • Proteins and Antibodies
    • Use of GPCRs as targets for peptide analogs
    • Blocking of receptors by antibodies
    • Evaluation of anti-drug antibodies
      • Preclinical assessment (In vitro binding, activation and neutralization assays)
      • Clinical evaluation
        • Effect of antibody formation of efficacy
        • Potential safety concerns
  • Drug Development Strategy
    • Clinical Trial strategies for Proof-of-Concept studies
    • Selection of appropriate populations
    • Phase I-IV clinical studies
  • Clinical Development Plan
    • Suitable plans for different geographies (EU, US, Japan, China)
    • Tailoring of plans with regards to regulatory and marketing requirements
  • Clinical Trials (Phase 1-4)
    • Design
      • Choice of endpoints
      • Primary and secondary hypotheses
      • Selections of population
      • Inclusion/exclusion criteria
      • Study duration and design
    • Execution
      • Safety monitoring
      • Interim analyses
      • DSMB
    • Data Analysis
      • Data cleaning and analysis
      • TFL/report preparation
    • Clinical Study Reports
      • Data interpretation
      • Report writing
    • Publication of Study results
      • Manuscript preparation
      • Selection of Jounals and Venues
      • Abstract submissions
      • Powerpoint data presentation development and optimization
  • Registration Europe/USA/Japan
    • Submission of regulatory documents
    • Scientific Advice CHMP/FDA Hearings
    • PIP/PDCO Hearings
    • Label/SPC preparation and negociation
  • Medical Affairs Support
    • Medical input into marketing strategy
    • Design of Phase IIIb and IV studies
    • Publications
    • Medical Marketing Strategy
  • Injection Devices
    • Design and Testing of new devices
    • Insulin Pens and Pumps
  • International Symposia
    • Symposia concepts
    • Organization of conferences
    • Chairing and presentations of scientific meetings

Curriculum Vitae

Michael E. Trautmann, M.D. Hamburg, Germany
Internist - Diabetology

studied medicine at the Universities of Goettingen, Marburg and Geneva in Germany and Switzerland. He was awarded a postdoctoral research fellowship from the German National Research Foundation at the Institute of Experimental Diabetology and Clinical Biochemistry (Head: A.E. Renold), University of Geneva 1985-1987. In collaboration with C.B. Wollheim he investigated the control of insulin secretion in islets of Langerhans and insulin-secreting tumors and cell lines.

His clinical training 1987-1992 was completed with the specialization in Internal Medicine and Diabetology at the University Hospital in Marburg, Department of Internal Medicine, Division of Gastroenterology and Metabolism. In his laboratory studies continued on secretory mechanisms and cellular differentiation of beta cells and the signaling of Glucagon-like peptide 1. He was responsible for the Diabetes Training Program and Outpatient care for patients with diabetes. As an investigator he participated in numerous clinical trials in the area diabetes and gastroenterology. He organized a multicenter trial on the treatment of patients with endocrine gastrointestinal tumors. In 1993, he joined Lilly Germany as Clinical Research Physician for Diabetes where he was responsible for the clinical development of insulin lispro (Humalog). 1994 - 1995 he was responsible for Diabetes research in Europe in the Lilly Research Laboratories Regional Medical Center in Bad Homburg, Germany.

From 1996 to 1998 he was Global Physician in the Endocrine Therapeutic Area in Indianapolis with responsibilities for early phase development of novel therapeutic approaches in the area of obesity and Type 2 diabetes treatment. 1998-2000 he was Head of Endocrine Clinical Investigation Europe at Lilly Research Laboratories in Hamburg (formerly Beiersdorf-Lilly) and coordinated early phase clinical programs in Europe as well as acting Head of Endocrine Discovery LRL Hamburg in 1998.

In 2001 he worked for Clinical Pharmacology and Program Phase Clinical Development in London as Global Physician for drug development for the treatment of Type 2 diabetes. From 2002 on he led the clinical team in a Phase 2 development program for the diabetes drug LY307161 (GLP-1 analog). He was working as Medical Advisor since fall 2002 and as Medical Fellow since May 2004 in the Exenatide Global Brand Development Team. His responsibilities included the scientific support for Exenatide (Byetta) and the registration of Byetta in Europe. He was integrally involved in the development of a long-acting formulation Exenatide (Bydureon) once weekly. In October 2009 he was promoted to Senior Medical Fellow in the Lilly Diabetes Development Medical group. He retired in January 2012 from Eli Lilly and now works as independent consultant for Diabetes drug development and Diabetes research for several companies on projects related to Diabetes, particularly insulin development, GLP-1 agonists, gastrointestinal hormones, new drugs for the treatment of Diabetes and Obesity, and devices. Among the clients are Bristol-Meyers-Squibb/Astra-Zeneca, Merck MSD, CeQur, Profil Institute San Diego, and Hanmi Pharmaceuticals.

Scientific Curriculum Vitae

10.06.1956 Born in Peine, Germany
1962-1975 School education, Abitur Gymnasium Walsrode, Germany
1975-1977 Military Service (Lieutenant)
1977-1985 Study of Law and Medicine at the Georg-August University Göttingen and at the Philipps-University Marburg, Germany

MD thesis: Effects of vagotomy on the endocrine pancreas (an immunohistological study in the laboratories of Professor W. Creutzfeldt, University of Göttingen, Dept. of Medicine, and Professor R. Arnold, University of Marburg, Dept. of Medicine)
16.11.84-15.02.85 Internship at the University Hospital of the Philipps-University Marburg, Department of Internal Medicine, Division of Gastroenterology and Metabolism (head: Prof. Dr. R. Arnold)
16.02.85-15.02.87 Research fellowship by the German National Research Foundation (Deutsche Forschungsgemeinschaft, Bonn-Bad Godesberg) at the Institute of Experimental Diabetology and Clinical Biochemistry, University of Geneva, Switzerland (head: Prof. Dr. A. E. Renold)

Scientific projects in collaboration with Prof. C. B. Wollheim:
  • Insulin release from insulin-producing tumors
  • Establishment of insulin-secreting cell lines from rat insulinomas
  • Characterization of glucose transport into insulin-secreting cells
  • Characterization of glucose phosphorylation and glucose metabolism in beta-cells
  • Mechanisms of intracellular signal transduction controlling insulin release
  • Cytosol calcium level measurements in living cells using fluorescent dye techniques
16.02.87-28.02.93 Specialization in Internal Medicine and Diabetology/Endocrinology/ Gastroenterology at the University Hospital of the Philipps-University Marburg, Department of Internal Medicine, Division of Gastroenterology and Metabolism (head: Prof. Dr. R. Arnold)

Clinical focus:
  • Establishment of a diabetes teaching unit with a structured training program
  • Organization of outpatient care for patients with diabetes
  • Supervision of the diabetes team: Nurse educator and dietitian
  • Training of students, nurses, and physicians in diabetes care
Clinical research:
  • Use of computers for diabetes assessment
  • Treatment of metastatic endocrine tumors in the gastrointestinal tract with somatostatin analogues and interferon: Coordination of studies including a multicenter trial involving 120 patients in 43 centers in Germany
  • Characterization of somatostatin receptors on endocrine tumors using in vitro and in vivo methods: Clinical evaluation of somatostatin analogue scintigraphy
  • Clinical investigator in several clinical trials in various development phases
Basic Research:
  • Differentiation of insulin-producing cells in cell culture systems (supported by the German National Research Foundation (DFG)
  • Intracellular signaling of GLP-I induced insulin secretion
  • Regulation of membrane potential and cytosol calcium
  • Cell culture of human endocrine gastrointestinal tumor cells
01.03.93-30.11.94 Clinical Research Physician responsible for Diabetes Care in the Medical Department of Lilly Germany:
  • Organization of clinical research: Single- and multi-center trials (Phase I- IV: Protocol development, start-up, monitoring, final report, publication) with a team of Research Associates and Clinical Investigation Assistants
  • Regulatory issues
  • Marketing support
  • Advice for requests from physicians, pharmacists, patients, organizations and journalists
  • Opinion leader contacts
  • Scientific presentations at national and international meetings and symposia
  • Coordination of collaborations in basic research
01.10.94-31.12.95 Clinical Research Physician responsible for Diabetes Care in the Regional Medical Center Diabetes Care and Endocrinology (Europe, Middle East, Africa) Lilly Research Laboratories, Indianapolis, in Bad Homburg, Germany:
  • Coordination of basic and clinical research in Europe
  • Opinion leader contacts (Advisory boards)
  • Regulatory planning: Clinical plan development
  • Scientific advice and presentations
  • Press contacts
  • Chairman of Global Scientific Advisory Group
01.01.96-01.08.98 Senior Clinical Research Physician Therapeutic Area Diabetes and Endocrinology, Lilly Research Laboratories, Indianapolis, USA:
  • Global coordination of basic and clinical research for new proteins in the area of Obesity and Type II Diabetes treatment (Global physician)
  • Regulatory planning: Clinical plan development
  • Scientific advice and presentations
01.08.98-01.02.01 Head of Endocrine Clinical Investigation Europe at Lilly Research Laboratories in Hamburg, Germany (formerly Beiersdorf-Lilly):
  • Global coordination of basic and clinical research for new treatments in the area of Type II Diabetes treatment (Global physician)
  • 1998 acting Director of Endocrine Research
  • Medical leader of GLP-1 receptor agonist programs
01.02.01-31.12.01 Senior Clinical Research Physician German Affiliate and Clinical Pharmacology and Program Phase Clinical Development in London:
  • Global coordination of basic and clinical research for new treatments in the area of Obesity and Type II Diabetes treatment (Global physician and Clinical Action Team leader)
01.01.02-31.12.02 Senior Clinical Research Physician and clinical team leader in a Phase 2 development program for a diabetes drug at LRL Indianapolis (based in Lilly Research Hamburg, Germany)
  • Medical leader of GLP-1 receptor agonist programs
01.01.03-01.05.04 Medical Advisor in the Exenatide Product Team, LRL Indianapolis (based in Hamburg, Germany) and Amylin, San Diego
01.05.04-30.09.05 Medical Fellow I, Exenatide Global Brand Development Team, LRL Indianapolis (based in Hamburg, Germany):
  • Medical Lead for the registration of Byetta in Europe
01.10.05-30.09.09 Medical Fellow II, Exenatide Global Brand Development Team, LRL Indianapolis (based in Hamburg, Germany):
  • Development of the long-acting preparation of Exenatide (LAR/QW)
01.10.09-31.12.10 Senior Medical Fellow, Exenatide Global Brand Development Team, LRL Indianapolis
  • Medical Lead for the registration of Bydureon in Europe
01.01.11-31.01.12 Senior Medical Fellow, Lilly Diabetes Global Medical Team, LRL Indianapolis
  • Development of new insulins
  • Evaluation of new targets for Diabetes drugs
  • Use of gastrointestinal hormone pathways for Diabetes therapy
01.03.13-ongoing Independent consultant for Diabetes drug development and Diabetes research

Membership in Societies:
American Diabetes Association (ADA)
European Association for the Study of Diabetes (EASD)
Endocrine Society (USA)
International Diabetes Federation (IDF)
German Diabetes Association (DDG)
Association for Pharmaceutical Medicine

Reviewer for many international scientific journals

List of publications (Full papers and reviews):

H. Koop, H. Schwarting, M. Trautmann, H.W. Börger, P.G. Lankisch, R. Arnold, W. Creutzfeldt: Trophic effect of truncal vagotomy on the rat pancreas. Digestion (1986) 33, 198-205

M.E. Trautmann, C.B. Wollheim: Characterization of glucose transport in an insulin-secreting cell line. Biochem. J. (1987) 242, 625-630

R. Göke, M.E. Trautmann, E. Haus, G. Richter, H.C. Fehmann, R. Arnold, B. Göke: Signal transmission after GLP-1(7-36)amide binding in RINm5F cells. Am J Physiol (1989) 257, G397-G401

R. Göke, G. Richter, M. Trautmann, R. Arnold: Internalization of glucagon-like peptide-1(7-36)amide in rat insulinoma cells. Res. Exp. Med. (1989) 189, 257-264

H.C. Fehmann, B. Göke, R. Göke, M.E. Trautmann, R. Arnold: Synergistic stimulatory effect of glucagon-like peptide-1 (7- 36)amide and glucose-dependent insulin-releasing polypeptide on the endocrine rat pancreas. FEBS-letter (1989) 252, 109-112

R. Göke, H.C. Fehmann, G. Richter, M. Trautmann, B. Göke: Interaction of glucagon-like peptide-1(7-36)amide and Somatostatin- 14 in RINm5F cells and in the perfused rat pancreas. Pancreas (1989) 4, 668-673

M.E. Trautmann, B. Blondel, A. Gjinovci, C. B. Wollheim: Inverse Relationship between glucose metabolism and glucose-induced insulin secretion in rat insulinoma cells. Hormone Research (1990) 34, 75-82

R. Arnold, C. Neuhaus, M. Trautmann: Klinische Anwendung von Octreotide bei Gastroenteropankreatischen (GEP) Tumoren. Z. Gastroenterol. (1990) 28, Suppl. 2, 22-28

H.C. Fehmann, B. Göke, V. Weber, R. Göke, M.E. Trautmann, G. Richter, R. Arnold: Interaction of glucagon-like peptide-1 (7- 36)amide and cholecystokinin-8 in the endocrine and exocrine rat pancreas. Pancreas (1990) 5, 361-365

H.C. Fehmann, B. Noll, R. Göke, B. Göke, M.E. Trautmann, R. Arnold: Atrial natriuretic factor has a weak insulinotropic action in the perfused rat pancreas. Res. Exp. Med. (1990) 190, 253-258

C. Neuhaus, M.E. Trautmann, R. Arnold: Sandostatin-Studie zur Therapie metastasierter endokriner Tumore des Gastrointestinal- Trakts. Sandorama (1990)

I. Koop, M. Lindenthal, M. Schade, M. Trautmann, G. Adler, R. Arnold: Role of Cholecystokinin in Cholestyramine-induced Changes of the Exocrine Pancreas. Pancreas (1991) 6, 564-570

M.E. Trautmann, C. Neuhaus, R. Arnold: Endokrine aktive Pankreastumoren aus internistischer Sicht. In: Pankreas - Diagnostik, Therapie, hsrg. v. W. Kozuschek, K.J. Paquet 1992

K. Joseph, J. Stapp, J. Reinecke, H. Höffken, R. Benning, C. Neuhaus, M.E. Trautmann, W.B. Schwerk, R. Arnold: Rezeptorszintigraphie bei endokrinen gastroenteropankreatischen Tumoren. Dtsch. med. Wschr. (1992) 117, 1025-1028

R. Arnold, C. Neuhaus, M.E. Trautmann: Therapie endokriner gastroenteropankreatischer Tumoren mit dem Somatostatin-Analogon Octerotid. Dtsch. med. Wschr. (1992) 117, 1067-1071

M.E. Trautmann, C. Neuhaus, R. Arnold: Endokrin aktive Pankreastumoren. Z. ärztl. Fortbild. (1992) 86, 649-657

B. Swarovsky. M. Eisenacher, M.E. Trautmann, R. Göke, R. Arnold: Stimulation of insulin release is uncoupled from insulin biosynthesis in tumoral RINm5F cells. Pancreas (1992) 7, 245-250

M.E. Trautmann, C. Neuhaus, H. Lenze, R. Benning, M. benning, H.J. Dennler, C. Bruns, K. Joseph, R. Arnold: The role of somatostatin analogs in the treatment of endocrine gastrointestinal tumors. Horm Metab Res (1993) 27 Suppl., 24-27

M.E. Trautmann, H. Koop, R. Arnold: Was ist gesichert in der Behandlung von endokrinen Tumoren des Gastrointestinaltrakts? Internist (1993) 34, 43-50

J. Rüschoff, S. Willemer, M. Brunzel, M.E. Trautmann, M. Frank, R. Arnold, G. Klöppel: Nucleolar organizer regions and glycoprotein-hormone alpha-chain reaction as markers of malignancy in endocrine tumours of the pancreas. Histopathology (1993) 22, 51-57

R. Arnold, R. Benning, C. Neuhaus, M. Rolwage, M.E. Trautmann: Gastroenteropancreatic endocrine tumours: effect of Sandostatin on tumor growth. Digestion (1993) 54 Suppl., 72-75

K. Joseph, J. Stapp, J. Reinecke, H.J. Skamel, H. Höffken, R. Benning, C. Neuhaus, H. Lenze, M.E. Trautmann, R. Arnold: Rezeptorszintigraphie mit 111In-Pentetreotid bei endokrinen gastroenteropankreatischen Tumoren. Nuklearmedizin (1993) 32, 299- 305

R.J. Weinel, C. Neuhaus, J. Stapp, H.J. Klotter, M.E. Trautmann, K. Joseph, R. Arnold, M. Rothmund: Preoperative localization of gastrointestinal tumors using somatostatin-receptor scintigraphy. Ann Surg (1993) 218, 640-645

R. Arnold, C. Neuhaus, R. Benning, W.B. Schwerk, M.E. Trautmann, K. Joseph, C. Bruns: Somatostatin analog sandostatin and inhibition of tumor growth in patients with metastatic endocrine gastroenteropancreatic tumors. World J Surg (1993) 17, 511-519

R. Eissele, C. Neuhaus, M.E. Trautmann, A. Funk, R. Arnold, H. Höfler: Immunoreactivity and expression of amylin in gastroenteropancreatic endocrine tumors. Am J Pathol (1993) 143, 283-291

R. J. Weinel, C. Neuhaus, H.J. Klotter, M.E. Trautmann, R. Arnold, M. Rothmund: Standardisiertes chirurgisches Konzept zur Diagnostik und Therapie des Zollinger-Ellison-Syndroms. Dtsch Med Wochenschr (1993) 118, 485-492

K. Joseph, J. Stapp, J. Reinecke, H.J. Skamel, H. Höffken, C. Neuhaus, H. Lenze, M.E. Trautmann, R. Arnold: Rezeptor scintigraphy with 111In-Pentetreotid for endocrine gastroenteropancreatic tumors. Horm Metab Res (1993) 27 Suppl., 28-35

H.P. Bode, B. Eder, M. Trautmann: An investigation on the role of vacuolar-type proton pumps and luminal acidity in calcium sequestration by nonmitochondrial and inositol-1,4,5-trisphosphate-sensitive intracellular calcium stores in clonal insulin-secreting cells. Eur. J. Biochem. (1994) 222, 869-877

B. Swarovsky, R. Eissele, M. Eisenacher, M.E. Trautmann, R. Arnold: Sodium butyrate induces neuroendocrine cytodifferentiation in the insulinoma cell line RINm5F. Pancreas (1994) 4, 460-468

M.E. Trautmann: Effect of the insulin analogue [Lys(B28),Pro(B29)] on blood glucose control. Horm Metab Res (1994) 26, 588-590

M. Grossmann, M.E. Trautmann, S. Poertl, R. Hoermann, P. Berger, R. Arnold, K. Mann: Alpha-subunit and human chorionic gonadotropin-beta immunoreactivity in patients with malignant endocrine gastroenteropancreatic tumours. Eur J Clin Invest (1994) 24, 131-136

A. Arnold, M.E. Trautmann, W. Creutzfeldt, et al.: Somatostatin Analogue Octreotide and Inhibition of Tumour Growth in Metastatic Endocrine Gastroenteropancreatic Tumours. GUT 1996, 38, 430-438

Heinemann L, Heise T, Wahl, LC, Trautmann ME, Ampudia J, Starke AAR, Berger M: Prandial Glycemia after a Carbohydrate-rich Meal in Type I Diabetic Patients: Using the Rapid Acting Insulin Analogue [Lys(B28), Pro(B29)] Human Insulin. Diabetic Medicine 1996, 13, 625-629

Pfuetzner A, Kuestner E, Forst T, Schulze-Schleppinghoff B, Trautmann ME, Haslbeck M, Schatz H, Beyer J: Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycemic episodes. Endocrinology and Diabetes 1996, 104, 25-30

DiMarchi R, Trautmann ME: Insulin lispro: Molekularstruktur und biologische Wirkungen (Insulin lispro: Molecular structure and biological activity). Diabetes und Stoffwechsel 1996, 3, 113-116

Trautmann ME, Pfuetzner A: Einsatz von Insulin lispro bei der intensivierten Insulintherapie (Use of insulin lispro during intensive insulin therapy). Diabetes und Stoffwechsel 1996, 3, 122-125

Henrichs HR, Unger H, Trautmann ME, Pfuetzner A: Long-term Treatment of a Case of Severe Insulin Resistance Using Insulin Lispro, a Short and Rapid-Acting Insulin Analogue. Lancet 1996, 348, 1248-1249

M.E. Trautmann: Insulin Secretion Targets/Targets for the Treatment of Diabetic Complications (Chairman). IBC UK Conference: Non-Insulin Dependent Diabetes, Amsterdam Dec. 4-5, 1996

M.E. Trautmann: Leptin in Human Obesity. IBC UK Conference: Obesity Treatments, Amsterdam Dec. 5-6, 1996

Anderson JH, Brunelle RL, Koivisto VA, Pfuetzner A, Trautmann ME, Vignati L, DiMarchi R: Reduction of Postprandial Hyperglycemia and Frequency of Hypoglycemia in IDDM Patients on Insulin-Analog Treatment. Diabetes 1997, 46, 265-270

Anderson JH, Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R, et al.: Insulin Analogue improves Mealtime Treatment of NIDDM Patients. Archives of Internal Medicine 1997, 157, 1249-1255

Anderson JH, Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R, et al.: Improved Mealtime Treatment of Diabetes Mellitus Using an Insulin Analogue. Clinical Therapeutics 1997, 19, 62-72

Stiller R, Gudat U, Pfuetzner A, Trautmann ME, Haslbeck M: Postprandial Treatment with Lispro Insulin. Diabetes and Metabolism 1997, 23, 232-233

Herschbach P, Duran G, Waadt S, Marten-Mittag B, von Rad M, Attanasio A, Trautmann ME, Schulze J, Ratzmann KP: Psychosoziale Belastungen von Patienten mit Diabetes mellitus (Psychological Well-being of Diabetic Patients in Eastern and Western Germany). Diabetes und Stoffwechsel 1997, 6, 3-7

Goldstein DJ, Trautmann ME: Treatments for Obesity. IN: Emerging Drugs: The prospect for Improved Medicines, Ashley Publications, 1997

Roach P., Trautmann M., Arora V,. Sun B., Anderson JH Jr.: Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Clinical Therapeutics. 21, 523-34, 1999

Renner R., Pfutzner A., Trautmann M., Harzer O., Sauter K., Landgraf R.: Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Diabetes Care. 22, 784-8, 1999

Bastyr EJ 3rd. Johnson ME. Trautmann ME. Anderson JH Jr. Vignati L.: Insulin lispro in the treatment of patients with type 2 diabetes mellitus after oral agent failure. Clinical Therapeutics. 21(10):1703-14, 1999

Herschbach P, Duran G, Attanasio A, Trautmann ME, Lindner U, Schulze J, Pfützner A: Psychological well-being in patients with diabetes mellitus in eastern and western Germany – A comparison between 1992 and 1997. Diabetes und Stoffwechsel 2000, 9, 207 - 211

Fehse F., Trautmann M., Holst J.J., Halseth A. E., Nanayakkara N., Nielsen L., Fineman M.S., Kim D.D., Nauck M.A.: Exenatide Augments First and Second Phase Insulin Secretion in Response to Intravenous Glucose in Subjects with Type 2 Diabetes. J Clin Endocrinol Metab 2005, 90, 5991 – 5997

Carpenter T, Trautmann ME, Baron AD: Hyperinsulinemic hypoglycemia with nesidioblastosis after gastric-bypass surgery (letter to the editor). New England Journal of Medicine 2005, 353, 2192

Linnebjerg H., Kothare PA., Skrivanek Z., de la Pena A., Atkins M., Ernest CS., Trautmann ME.: Exenatide: effect of injection time on postprandial glucose in patients with Type 2 diabetes. Diabetic Medicine. 23(3):240-5, 2006 Mar.

Blonde L., Klein EJ., Han J., Zhang B., Mac SM., Poon TH., Taylor KL., Trautmann ME., Kim DD., Kendall DM.: Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes, Obesity & Metabolism. 8(4):436-47, 2006 Jul.

Nauck MA., Duran S., Kim D., Johns D., Northrup J., Festa A., Brodows R., Trautmann M.: A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a noninferiority study. Diabetologia. 50(2):259-67, 2007 Feb.

Zinman B., Hoogwerf BJ., Duran Garcia S., Milton DR., Giaconia JM., Kim DD., Trautmann ME., Brodows RG.: The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Annals of Internal Medicine. 146(7):477-85, 2007 Apr 3.

Kim D., MacConell L., Zhuang D., Kothare PA., Trautmann M., Fineman M., Taylor K.: Effects of once-weekly dosing of a longacting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care. 30(6):1487-93, 2007 Jun.

Barnett AH., Burger J., Johns D., Brodows R., Kendall DM., Roberts A., Trautmann ME.: Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clinical Therapeutics. 29(11):2333-48, 2007 Nov.

Glass LC., Qu Y., Lenox S., Kim D., Gates JR., Brodows R., Trautmann M., Bergenstal RM.: Effects of exenatide versus insulin analogues on weight change in subjects with type 2 diabetes: a pooled post-hoc analysis. Current Medical Research & Opinion. 24(3):639-44, 2008 Mar.

Linnebjerg H., Park S., Kothare P. A., Trautmann M.E., Mace K., Fineman M., Wilding I., Nauck M., Horowitz M.: Effect of Exenatide on Gastric Emptying and Relationship to Postprandial Glycemia in Type 2 Diabetes. Regulatory Peptides 2008 :151(1- 3):123-9

Drucker DJ, Buse JB, Taylor K, Kendall D, Trautmann M, Zhuang D, Porter L for the LARGO Study Group: Exenatide Once Weekly versus Twice Daily for the Treatment of Type 2 Diabetes. Lancet 2008: 372, 1240-50, 2008

Malone J, Trautmann M, Wilhelm K, Taylor K, Kendall DM: Exenatide once weekly for the treatment of type 2 diabetes. Expert Opin. Investig. Drugs (2009) 18 (3):359-367

Diamant M, van Gaal L, Stranks S, Northrup J, Dachuang C, Taylor K, Trautmann M: Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open label randomised trial. The Lancet, 2010: 375, 9733: 2234-2243

Liutkus J, Guzman RJ, Norwood P, Pop L, Northrup J, Cao D, Trautmann M: A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes, Obesity and Metabolism 2010, 12, 1058-1065

Deyoung MB, MacConell L, Sarin V, Trautmann M, Herbert P: Encapsulation of exenatide in poly-(d,l-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technology and Therapeutics. 2011: 13 (11): 1145-1154.

Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M: Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocrine Disorders. 2011: 11 Article Number: 9.

Blevins T, Pullman J, Malloy J, Yan P, Taylor K, Schulteis C, Trautmann M, Porter L: DURATION-5: Exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. Journal of Clinical Endocrinology and Metabolism. 2011: 96 (5) 1301-1310.

Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M: Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocrine Disorders. 2011: (11) 9.

Keller J, Trautmann ME, Haber H, Tham LS, Hunt T, Mace KF, Linnebjerg H: Effect of exenatide on cholecystokinin-induced gallbladder emptying in fasting healthy subjects. Regulatory Peptides 2012: 179, 77–83

Russel-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzales JG, Chan M, Wolka AM, Boardman MK (on behalf of the DURATION-4 study group): Efficacy and safety of exenatide once weekly versus Metformin, Pioglitazone, and Sitagliptin used as monotherapy in drug-naïve patients with type 2 diabetes (DURATION-4). Diabetes Care 2012, 35: 252-258 (contribution)

Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME: Clinical Relevance of Anti-exenatide Antibodies: Safety, Efficacy, and Cross-reactivity with Long-term Treatment. Diabetes, Obesity and Metabolism 2012

Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M: Safety and Efficacy of Once- Weekly Exenatide Comapred With Insulin Glargine Titrated to Target in Patients With Type 2 Diabetes Over 84 Weeks. Diabetes Care 2012, 35:683–689

Gallwitz B, Guzmàn J, Dotta F, Guerci B, Simó R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G: Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure: results of the EUREXA randomised trial. Lancet 2012: 379, 2270-2278

Norwood, P, Liutkus JF, Haber H, Pintilei E, Boardman MK, Trautmann ME: Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With a Thiazolidinedione Alone or in Combination With Metformin for 2 Years: Clinical Therapeutics 2012, 34, 2082-2090

DG Parkes, KF Mace, ME Trautmann: Discovery and development of exenatide: the first antidiabetic agent to leverage the multiple benefits of the incretin hormone, GLP-1: Expert Opinion on Drug Discovery, 2013, 8(2): 219-244

Impressum

Verantwortlich für den Inhalt:

Michael E. Trautmann
Fueerbarg 16a
22393 Hamburg
E-Mail: michael@trautmann-diabetes.de

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