Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People
NCT ID: NCT02308254
Last Updated: 2015-10-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-11-30
Study Completion Date
2016-04-30
Brief Summary
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The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood flow in the gut after a glucose drink in both healthy subjects and people with type 2 diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of its potential use in the management of the falls in blood pressure following a meal in diabetic patients.
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Detailed Description
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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.
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.
Conditions
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Diabetes Mellitus
Gastroparesis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Lixisenatide
Lixisenatide: 10 mcg, one subcutaneous injection dose
Group Type
ACTIVE_COMPARATOR
Lixisenatide
Intervention Type
DRUG
Abdominal administration
Placebo
Matching placebo: one subcutaneous injection dose
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Abdominal administration
Interventions
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Lixisenatide
Abdominal administration
Intervention Type
DRUG
Placebo
Abdominal administration
Intervention Type
DRUG
Other Intervention Names
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Lyxumia
Dummy
Eligibility Criteria
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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%
* 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:
1. Alanine aminotransferase (ALT) 0 - 55 U/L
2. Alkaline phosphatase 30 - 110 U/L
3. Aspartate transaminase 0 - 45 U/L
4. Amylase and/or lipase \>3 x ULN
5. Bilirubin 6 - 24 mmol/L
6. Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
7. 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
1. Alanine aminotransferase (ALT) 0 - 55 U/L
2. Alkaline phosphatase 30 - 110 U/L
3. Aspartate transaminase 0 - 45 U/L
4. Amylase and/or lipase \>3 x ULN
5. Bilirubin 6 - 24 mmol/L
6. Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
7. 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Sanofi
INDUSTRY
Sponsor Role
collaborator
National Health and Medical Research Council, Australia
OTHER
Sponsor Role
collaborator
Royal Adelaide Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Karen Jones
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Karen L Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Adelaide, Royal Adelaide Hospital
Locations
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Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Site Status
RECRUITING
Countries
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Australia
Central Contacts
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Facility Contacts
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References
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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.
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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.
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BACKGROUND
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).
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BACKGROUND
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).
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BACKGROUND
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BACKGROUND
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).
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BACKGROUND
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.
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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).
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BACKGROUND
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.
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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.
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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.
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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.
Reference Type
DERIVED
Other Identifiers
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130419
Identifier Type: -
Identifier Source: org_study_id
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