- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02308254
Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People (Lixi)
Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lixisenatide is a drug that has been shown to reduce postprandial glycaemia in people with type 2 diabetes and is now approved for use in Australia. Although slowing of gastric emptying is likely to be the dominant mechanism by which lixisenatide reduces postprandial glycaemia after a meal, the effects of lixisenatide on gastric emptying have hitherto not been quantified by the 'gold standard' technique of scintigraphy. The study would determine and evaluate for the first time the magnitude of, and the relationship between lixisenatide on glycaemia with those on gastric emptying with scintigraphy. This information will be of fundamental significance to the effective use of lixisenatide in the management of people with type 2 diabetes that suffer from postprandial hypotension.
Postprandial hypotension represents an important clinical disorder that occurs frequently in the elderly and people with type 2 diabetes and for which current management is suboptimal. While the mechanisms mediating postprandial hypotension are poorly understood, impaired regulation of splanchnic blood flow, gastric distension, the rate of small intestinal delivery and neural and hormonal mechanisms have been identified as possible pathophysiological mechanisms. Meal ingestion is associated with splanchnic blood pooling and a consequent reduction in venous return of blood to the heart. In healthy young and older individuals, with intact baroreflex mechanisms, these changes induce a rise in heart rate, stoke volume and cardiac output leading to a compensatory rise in blood pressure. However, patients with postprandial hypotension, these responses are inadequate to maintain blood pressure. The magnitude of the fall in blood pressure is greater when gastric emptying is more rapid and that slowing gastric emptying can markedly attenuate the postprandial fall in blood pressure in both healthy older subjects and type 2 patients.
There is currently no information about the effect of lixisenatide on postprandial blood pressure and splanchnic blood flow in patients with type 2 diabetes.
The purpose of this study would determine whether lixisenatide reduces the postprandial fall in blood pressure and related effects of gastric emptying to those on blood pressure, heart rate and splanchnic blood flow.
The use of lixisenatide on appetite and energy intake and how these relate to effects of gastric emptying is lacking.
It is hypothesized that lixisenatide will slow gastric emptying of oral glucose; attenuate both fasting and the postprandial rise in blood glucose; attenuate the magnitude of the fall in blood pressure, rise in heart rate and increase in SMA flow and reduce hunger, increase fullness and decrease energy intake at a buffet meal with greater effects in patients with type 2 diabetes that healthy subjects.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Rachael S Tippett, BSc Honours
- Phone Number: 2915 8222 2915
- Email: rachael.tippett@adelaide.edu.au
Study Contact Backup
- Name: Laurence G Trahair, BHlthSci Hon
- Phone Number: 2915 8222 2915
- Email: laurence.trahair@adelaide.edu.au
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Recruiting
- Discipline of Medicine, Royal Adelaide Hospital
-
Contact:
- Karen L Jones, PhD
- Phone Number: 25394 +61 8 8222 5394
- Email: karen.jones@adelaide.edu.au
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Contact:
- Michael Horowitz, PhD, FRACP
- Phone Number: 24327 +61 8 8222 4327
- Email: michael.horowitz@adelaide.edu.au
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Principal Investigator:
- Karen L Jones, PhD
-
Sub-Investigator:
- Laurence G Trahair, BHlthSci Hon
-
Sub-Investigator:
- Rachael S Tippett, BSc Honours
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Sub-Investigator:
- Chris Rayner, PhD, FRACP
-
Sub-Investigator:
- Michael Horowitz, PhD, FRACP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy subjects:
- Male or female (females using appropriate contraceptive method or willing to undergo pregnancy test)
- Body Mass Index (BMI) 19 - 30 kg/m2
Type 2 Diabetic Patients:
- As per "healthy subjects"
- Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
- Glycated haemoglobin >6.0% and <8.5%
Exclusion Criteria:
Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestations of the disease, or living with the condition, impact negatively and significantly on the individuals' ability to lead a normal day to day life), chronic alcohol abuse or epilepsy (excluded by history) or if iron status, or liver function tests are outside the following ranges:
- Alanine aminotransferase (ALT) 0 - 55 U/L
- Alkaline phosphatase 30 - 110 U/L
- Aspartate transaminase 0 - 45 U/L
- Amylase and/or lipase >3 x ULN
- Bilirubin 6 - 24 mmol/L
- Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
- Haemoglobin 115 - 155 g/L (females); 135 - 172 g/L (males)
- Subjects with a creatinine clearance cut-off of <50 ml/min
- Subjects requiring medication likely to influence blood pressure or gastrointestinal function
- Subjects with a past history of gastrointestinal disease, including known gastroparesis, significant upper gastrointestinal symptoms and previous gastric surgery
- Subjects with a past history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
- Subjects with a current or prior history of c-cell carcinoma
- Smoking > 10 cigarettes/day
- Alchohol consumption > 20 g/day
- Subjects who have donated blood in the previous 12 weeks
- Women of childbearing potential with no effective contraceptive method (defined as premenopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative urine B-hCG pregnancy test at screening visit. They must also use an effective contraceptive method throughout the study, and agree to repeat urine pregnancy test at designated visits.
- Lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Lixisenatide
Lixisenatide: 10 mcg, one subcutaneous injection dose
|
Abdominal administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Matching placebo: one subcutaneous injection dose
|
Abdominal administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: 4.5 hours per study
|
Systolic and diastolic blood pressure (mmHg)
|
4.5 hours per study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 4.5 hours per study
|
Heart rate (beats per minute)
|
4.5 hours per study
|
Gastric emptying rate
Time Frame: 3 hours per study
|
Gastric retention (percent in the total stomach)
|
3 hours per study
|
Blood glucose concentration
Time Frame: 3 hours per study
|
Blood glucose (mmol/L)
|
3 hours per study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intragastric distribution
Time Frame: 3 hours per study
|
percent retention in the proximal and distal stomach
|
3 hours per study
|
Gastrointestinal hormone release (concentrations of GLP-1, GIP, C-peptide and 3-OMG)
Time Frame: 4.5 hours per study
|
concentrations of GLP-1, GIP, C-peptide and 3-OMG
|
4.5 hours per study
|
Superior mesenteric artery blood flow
Time Frame: 3.5 hours per study
|
Doppler ultrasound (ml/min)
|
3.5 hours per study
|
Appetite (visual analogue questionnaire)
Time Frame: 4.5 hours per study
|
sensations of hunger, fullness, desire to eat (mm)
|
4.5 hours per study
|
Cardiac output
Time Frame: 3.5 hours per study
|
Finapres (L)
|
3.5 hours per study
|
Stroke volume
Time Frame: 3.5 hours per study
|
Finapres (L)
|
3.5 hours per study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen L Jones, PhD, University of Adelaide, Royal Adelaide Hospital
Publications and helpful links
General Publications
- Horowitz M, Rayner CK, Jones KL. Mechanisms and clinical efficacy of lixisenatide for the management of type 2 diabetes. Adv Ther. 2013 Feb;30(2):81-101. doi: 10.1007/s12325-013-0009-4. Epub 2013 Feb 13.
- Nauck MA, Niedereichholz U, Ettler R, Holst JJ, Orskov C, Ritzel R, Schmiegel WH. Glucagon-like peptide 1 inhibition of gastric emptying outweighs its insulinotropic effects in healthy humans. Am J Physiol. 1997 Nov;273(5):E981-8. doi: 10.1152/ajpendo.1997.273.5.E981.
- Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Aug;36(4):379-90. doi: 10.1111/j.1365-2036.2012.05198.x. Epub 2012 Jun 28.
- Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. doi: 10.7326/0003-4819-122-4-199502150-00009.
- Jones KL, Tonkin A, Horowitz M, Wishart JM, Carney BI, Guha S, Green L. Rate of gastric emptying is a determinant of postprandial hypotension in non-insulin-dependent diabetes mellitus. Clin Sci (Lond). 1998 Jan;94(1):65-70. doi: 10.1042/cs0940065.
- Gentilcore D, Bryant B, Wishart JM, Morris HA, Horowitz M, Jones KL. Acarbose attenuates the hypotensive response to sucrose and slows gastric emptying in the elderly. Am J Med. 2005 Nov;118(11):1289. doi: 10.1016/j.amjmed.2005.05.019. No abstract available.
- Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
- Schirra J, Houck P, Wank U, Arnold R, Goke B, Katschinski M. Effects of glucagon-like peptide-1(7-36)amide on antro-pyloro-duodenal motility in the interdigestive state and with duodenal lipid perfusion in humans. Gut. 2000 May;46(5):622-31. doi: 10.1136/gut.46.5.622.
- Brennan IM, Feltrin KL, Horowitz M, Smout AJ, Meyer JH, Wishart J, Feinle-Bisset C. Evaluation of interactions between CCK and GLP-1 in their effects on appetite, energy intake, and antropyloroduodenal motility in healthy men. Am J Physiol Regul Integr Comp Physiol. 2005 Jun;288(6):R1477-85. doi: 10.1152/ajpregu.00732.2004. Epub 2005 Feb 3.
- Little TJ, Pilichiewicz AN, Russo A, Phillips L, Jones KL, Nauck MA, Wishart J, Horowitz M, Feinle-Bisset C. Effects of intravenous glucagon-like peptide-1 on gastric emptying and intragastric distribution in healthy subjects: relationships with postprandial glycemic and insulinemic responses. J Clin Endocrinol Metab. 2006 May;91(5):1916-23. doi: 10.1210/jc.2005-2220. Epub 2006 Feb 21.
- Delgado-Aros S, Kim DY, Burton DD, Thomforde GM, Stephens D, Brinkmann BH, Vella A, Camilleri M. Effect of GLP-1 on gastric volume, emptying, maximum volume ingested, and postprandial symptoms in humans. Am J Physiol Gastrointest Liver Physiol. 2002 Mar;282(3):G424-31. doi: 10.1152/ajpgi.2002.282.3.G424.
- Horowitz M, Nauck MA. To be or not to be--an incretin or enterogastrone? Gut. 2006 Feb;55(2):148-50. doi: 10.1136/gut.2005.071787.
- Riddle M, Home P, Marre M, Niemoeller E, Ping L, Rosenstock J. Efficacy and safety of once-daily lixisenatide in type 2 diabetes insufficiently controlled with basal insulin ± metformin: GetGoal-L Study. Diabetes 2012;61(Suppl 1):A212-A344 (Abstract 983-P).
- Rosenstock J, Forst T, Aronson R, et al. Efficacy and safety of once-daily lixisenatide added on to titrated glargine plus oral agents in type 2 diabetes: GetGoal-Duo 1 Study. Presented at the 72nd Scientific Sessions of the American Diabetes Association, Philadelphia PA, 8-12 June 2012 (Abstract 62-OR).
- Ahrén B, Dimas L, Miossec P, Saubado S, Aronson R. Efficacy and safety of lixisenatide QD morning and evening injections vs placebo in T2DM inadequately controlled on metformin (GetGoal-M). Oral presentation at the 21st World Diabetes Congress, Dubai, UAE, 8 December 2011 (Abstract 0-0591).
- Ratner R, Hanefield M, Shamanna P, et al. Efficacy and safety of lixisenatide once daily versus placebo in patients with T2DM insufficiently controlled on sulfonylurea + metformin (GetGoal-S). Poster presented at 47th Annual Meeting of the European Association for the Study of Diabetes, 12-16 September 2011, Lisbon, Portugal. Diabetologia 2011;54(Suppl 1):1-542 (Abstract 785).
- Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.
- Rosenstock J, Raccah D, Koranyi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in patients with T2DM insufficiently controlled on metformin (GetGoal-X). Poster presented at 47th Annual Meeting of the European Association for the Study of Diabetes, 12-16 September 2011, Lisbon, Portugal. Diabetologia 2011;54(Suppl 1):1-542 (Abstract 786).
- Bolli G, Munteanu M, Dotsenko S, Niemoeller E, Boka G, Hanefield M. Efficacy and safety of lixisenatide once-daily versus placebo in patients with T2DM insufficiently controlled on metformin (GetGoal-F1). Poster presented at 47th Annual Meeting of the European Association for the Study of Diabetes, 12-16 September 2011, Lisbon, Portugal. Diabetologia 2011;54(Suppl 1): 1-542 (Abstract 784).
- Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012 Jun;35(6):1225-31. doi: 10.2337/dc11-1935. Epub 2012 Mar 19.
- Meier JJ, Kemmeries G, Holst JJ, Nauck MA. Erythromycin antagonizes the deceleration of gastric emptying by glucagon-like peptide 1 and unmasks its insulinotropic effect in healthy subjects. Diabetes. 2005 Jul;54(7):2212-8. doi: 10.2337/diabetes.54.7.2212.
- Christensen M, Knop FK, Vilsboll T, Holst JJ. Lixisenatide for type 2 diabetes mellitus. Expert Opin Investig Drugs. 2011 Apr;20(4):549-57. doi: 10.1517/13543784.2011.562191. Epub 2011 Mar 11.
- Shannon JR, Diedrich A, Biaggioni I, Tank J, Robertson RM, Robertson D, Jordan J. Water drinking as a treatment for orthostatic syndromes. Am J Med. 2002 Apr 1;112(5):355-60. doi: 10.1016/s0002-9343(02)01025-2.
- Vanis L, Gentilcore D, Lange K, Gilja OH, Rigda RS, Trahair LG, Feinle-Bisset C, Rayner CK, Horowitz M, Jones KL. Effects of variations in intragastric volume on blood pressure and splanchnic blood flow during intraduodenal glucose infusion in healthy older subjects. Am J Physiol Regul Integr Comp Physiol. 2012 Feb 15;302(4):R391-9. doi: 10.1152/ajpregu.00464.2011. Epub 2011 Nov 30.
- O'Donovan D, Feinle C, Tonkin A, Horowitz M, Jones KL. Postprandial hypotension in response to duodenal glucose delivery in healthy older subjects. J Physiol. 2002 Apr 15;540(Pt 2):673-9. doi: 10.1113/jphysiol.2001.013442.
- Mathias CJ. Postprandial hypotension. Pathophysiological mechanisms and clinical implications in different disorders. Hypertension. 1991 Nov;18(5):694-704. doi: 10.1161/01.hyp.18.5.694. No abstract available.
- Edwards CM, Todd JF, Ghatei MA, Bloom SR. Subcutaneous glucagon-like peptide-1 (7-36) amide is insulinotropic and can cause hypoglycaemia in fasted healthy subjects. Clin Sci (Lond). 1998 Dec;95(6):719-24. doi: 10.1042/cs0950719.
- Barragan JM, Rodriguez RE, Eng J, Blazquez E. Interactions of exendin-(9-39) with the effects of glucagon-like peptide-1-(7-36) amide and of exendin-4 on arterial blood pressure and heart rate in rats. Regul Pept. 1996 Nov 14;67(1):63-8. doi: 10.1016/s0167-0115(96)00113-9.
- White J. Efficacy and safety of incretin based therapies: clinical trial data. J Am Pharm Assoc (2003). 2009 Sep-Oct;49 Suppl 1:S30-40. doi: 10.1331/JAPhA.2009.09079.
- Jones KL, MacIntosh C, Su YC, Wells F, Chapman IM, Tonkin A, Horowitz M. Guar gum reduces postprandial hypotension in older people. J Am Geriatr Soc. 2001 Feb;49(2):162-7. doi: 10.1046/j.1532-5415.2001.49037.x.
- Gentilcore D, Nair NS, Vanis L, Rayner CK, Meyer JH, Hausken T, Horowitz M, Jones KL. Comparative effects of oral and intraduodenal glucose on blood pressure, heart rate, and splanchnic blood flow in healthy older subjects. Am J Physiol Regul Integr Comp Physiol. 2009 Sep;297(3):R716-22. doi: 10.1152/ajpregu.00215.2009. Epub 2009 Jun 24.
- Gentilcore D, Hausken T, Meyer JH, Chapman IM, Horowitz M, Jones KL. Effects of intraduodenal glucose, fat, and protein on blood pressure, heart rate, and splanchnic blood flow in healthy older subjects. Am J Clin Nutr. 2008 Jan;87(1):156-61. doi: 10.1093/ajcn/87.1.156.
- Langewouters GJ, Settels JJ, Roelandt R, Wesseling KH. Why use Finapres or Portapres rather than intra-arterial or intermittent non-invasive techniques of blood pressure measurement? J Med Eng Technol. 1998 Jan-Feb;22(1):37-43. doi: 10.3109/03091909809009997.
- Moneta GL, Taylor DC, Helton WS, Mulholland MW, Strandness DE Jr. Duplex ultrasound measurement of postprandial intestinal blood flow: effect of meal composition. Gastroenterology. 1988 Nov;95(5):1294-301. doi: 10.1016/0016-5085(88)90364-2.
- Iwao T, Toyonaga A, Shigemori H, Oho K, Sumino M, Sato M, Tanikawa K. Echo-Doppler measurements of portal vein and superior mesenteric artery blood flow in humans: inter- and intra-observer short-term reproducibility. J Gastroenterol Hepatol. 1996 Jan;11(1):40-6. doi: 10.1111/j.1440-1746.1996.tb00008.x.
- Zwolak RM, Fillinger MF, Walsh DB, LaBombard FE, Musson A, Darling CE, Cronenwett JL. Mesenteric and celiac duplex scanning: a validation study. J Vasc Surg. 1998 Jun;27(6):1078-87; discussion 1088. doi: 10.1016/s0741-5214(98)60010-0.
- Shimamoto H, Kito H, Kawazoe K, Fujita T, Shimamoto Y. [Validation of Doppler arterial flow in humans]. Kokyu To Junkan. 1992 Jul;40(7):673-6. Japanese.
- Marathe CS, Pham H, Wu T, Trahair LG, Rigda RS, Buttfield MDM, Hatzinikolas S, Lange K, Rayner CK, Mari A, Horowitz M, Jones KL. Acute Administration of the GLP-1 Receptor Agonist Lixisenatide Diminishes Postprandial Insulin Secretion in Healthy Subjects But Not in Type 2 Diabetes, Associated with Slowing of Gastric Emptying. Diabetes Ther. 2022 Jun;13(6):1245-1249. doi: 10.1007/s13300-022-01258-4. Epub 2022 Apr 22.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130419
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