Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes
NCT ID: NCT02324010
Last Updated: 2017-07-07
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
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
14 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-31
Study Completion Date
2017-01-31
Brief Summary
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The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying, after a mashed potato meal in patients with type 2 diabetes.
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Detailed Description
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The purpose of this study is to (i) evaluate the acute effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (100mg once daily for two days), on gastric emptying, postprandial plasma glucose, insulin, glucagon and 'incretin' hormones (ie. glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)), blood pressure and heart rate after a high carbohydrate meal, and (ii) to determine whether the magnitude of the effects of sitagliptin on postprandial glycaemia and blood pressure is related to the rate of gastric emptying, in patients with type 2 diabetes.
The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycaemic and blood pressure response to, a carbohydrate-containing meal.
Twenty healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones, blood pressure, splanchnic flow and appetite will be measured for 4 hours following ingestion of a mashed potato meal.
The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycaemic and blood pressure response to, a carbohydrate-containing meal.
Twenty healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones, blood pressure, splanchnic flow and appetite will be measured for 4 hours following ingestion of a mashed potato meal.
Conditions
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Gastroparesis
Diabetes Mellitus
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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Sitaglipltin (100mg)
Active drug (sitagliptin)
Group Type
EXPERIMENTAL
Placebo
Intervention Type
DRUG
Inactive drug (Placebo)
Placebo (sugar pill)
Inactive drug (placebo)
Group Type
PLACEBO_COMPARATOR
Sitagliptin
Intervention Type
DRUG
100mg mane for 2 days
Interventions
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Sitagliptin
100mg mane for 2 days
Intervention Type
DRUG
Placebo
Inactive drug (Placebo)
Intervention Type
DRUG
Other Intervention Names
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MK-0431-075, Januvia
Sugar pill
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet or metformin alone
* Body mass index (BMI) 20 - 40 kg/m2
* Males and females (females of reproductive potential must be using an appropriate contraceptive method)
* Glycated haemoglobin (HbA1c) ≤ 8.5%
* Haemoglobin above the lower limit of the normal range (i.e. \>135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. \>10mcg/L)
* Body mass index (BMI) 20 - 40 kg/m2
* Males and females (females of reproductive potential must be using an appropriate contraceptive method)
* Glycated haemoglobin (HbA1c) ≤ 8.5%
* Haemoglobin above the lower limit of the normal range (i.e. \>135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. \>10mcg/L)
Exclusion Criteria
* Subjects with gastrointestinal disease, significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
* Other significant illness, including epilepsy, cardiovascular or respiratory disease.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 50 mL/min using the Cockroft-Gault equation (27) or abnormal liver function tests (\> 2 times upper limit of normal range)).
* Requirement for medication known to influence blood pressure and/or heart rate and/or gastrointestinal function, drugs with anticholinergic effects
* Alcohol consumption \> 20 g per day
* Smoking \> 10 cigarettes per day
* Pregnancy or lactation.
* Vegetarian
* Allergy to sitagliptin or any other 'gliptin'.
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Exposure to ionising radiation for research purposes in the previous 12 months
* Inability to give informed consent
* Other significant illness, including epilepsy, cardiovascular or respiratory disease.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 50 mL/min using the Cockroft-Gault equation (27) or abnormal liver function tests (\> 2 times upper limit of normal range)).
* Requirement for medication known to influence blood pressure and/or heart rate and/or gastrointestinal function, drugs with anticholinergic effects
* Alcohol consumption \> 20 g per day
* Smoking \> 10 cigarettes per day
* Pregnancy or lactation.
* Vegetarian
* Allergy to sitagliptin or any other 'gliptin'.
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Exposure to ionising radiation for research purposes in the previous 12 months
* Inability to give informed consent
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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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, DAppSci, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Adelaide
Locations
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University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Site Status
Countries
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Australia
References
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Wu T, Rayner CK, Young RL, Horowitz M. Gut motility and enteroendocrine secretion. Curr Opin Pharmacol. 2013 Dec;13(6):928-34. doi: 10.1016/j.coph.2013.09.002. Epub 2013 Sep 20.
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BACKGROUND
Chaikomin R, Rayner CK, Jones KL, Horowitz M. Upper gastrointestinal function and glycemic control in diabetes mellitus. World J Gastroenterol. 2006 Sep 21;12(35):5611-21. doi: 10.3748/wjg.v12.i35.5611.
Reference Type
BACKGROUND
Horowitz M, Edelbroek MA, Wishart JM, Straathof JW. Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects. Diabetologia. 1993 Sep;36(9):857-62. doi: 10.1007/BF00400362.
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BACKGROUND
Jones KL, Horowitz M, Carney BI, Wishart JM, Guha S, Green L. Gastric emptying in early noninsulin-dependent diabetes mellitus. J Nucl Med. 1996 Oct;37(10):1643-8.
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BACKGROUND
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
Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology. 2007 May;132(6):2131-57. doi: 10.1053/j.gastro.2007.03.054.
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BACKGROUND
ELRICK H, STIMMLER L, HLAD CJ Jr, ARAI Y. PLASMA INSULIN RESPONSE TO ORAL AND INTRAVENOUS GLUCOSE ADMINISTRATION. J Clin Endocrinol Metab. 1964 Oct;24:1076-82. doi: 10.1210/jcem-24-10-1076. No abstract available.
Reference Type
BACKGROUND
Nauck M, Stockmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986 Jan;29(1):46-52. doi: 10.1007/BF02427280.
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BACKGROUND
Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Khoo J, Rayner CK, Jones KL, Horowitz M. Incretin-based therapies: new treatments for type 2 diabetes in the new millennium. Ther Clin Risk Manag. 2009 Jun;5(3):683-98. doi: 10.2147/tcrm.s4975. Epub 2009 Aug 20.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Vella A, Bock G, Giesler PD, Burton DB, Serra DB, Saylan ML, Dunning BE, Foley JE, Rizza RA, Camilleri M. Effects of dipeptidyl peptidase-4 inhibition on gastrointestinal function, meal appearance, and glucose metabolism in type 2 diabetes. Diabetes. 2007 May;56(5):1475-80. doi: 10.2337/db07-0136. Epub 2007 Feb 15.
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BACKGROUND
Woerle H, Lindenberger T, Linke R, Foley JE, Ligueros-Sayalan AA, ZhangY, He Y-L, BelingerC, Goeke B, Schirra J. A single dose of vidagliptin (VILDA) decelerates gastric emptying (GE) in patients with type 2 diabetes (T2DM). American Diabetes Association, 67th Scientific Sessions 500-p (abstract), 2007.
Reference Type
BACKGROUND
Wu T, Bound MJ, Zhao BR, Standfield SD, Bellon M, Jones KL, Horowitz M, Rayner CK. Effects of a D-xylose preload with or without sitagliptin on gastric emptying, glucagon-like peptide-1, and postprandial glycemia in type 2 diabetes. Diabetes Care. 2013 Jul;36(7):1913-8. doi: 10.2337/dc12-2294. Epub 2013 Jan 28.
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BACKGROUND
Rayner CK, Samsom M, Jones KL, Horowitz M. Relationships of upper gastrointestinal motor and sensory function with glycemic control. Diabetes Care. 2001 Feb;24(2):371-81. doi: 10.2337/diacare.24.2.371.
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BACKGROUND
Pilichiewicz AN, Chaikomin R, Brennan IM, Wishart JM, Rayner CK, Jones KL, Smout AJ, Horowitz M, Feinle-Bisset C. Load-dependent effects of duodenal glucose on glycemia, gastrointestinal hormones, antropyloroduodenal motility, and energy intake in healthy men. Am J Physiol Endocrinol Metab. 2007 Sep;293(3):E743-53. doi: 10.1152/ajpendo.00159.2007. Epub 2007 Jul 3.
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BACKGROUND
Ma J, Pilichiewicz AN, Feinle-Bisset C, Wishart JM, Jones KL, Horowitz M, Rayner CK. Effects of variations in duodenal glucose load on glycaemic, insulin, and incretin responses in type 2 diabetes. Diabet Med. 2012 May;29(5):604-8. doi: 10.1111/j.1464-5491.2011.03496.x.
Reference Type
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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BACKGROUND
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.
Reference Type
BACKGROUND
Russo A, Stevens JE, Wilson T, Wells F, Tonkin A, Horowitz M, Jones KL. Guar attenuates fall in postprandial blood pressure and slows gastric emptying of oral glucose in type 2 diabetes. Dig Dis Sci. 2003 Jul;48(7):1221-9. doi: 10.1023/a:1024182403984.
Reference Type
BACKGROUND
Vanis L, Gentilcore D, Rayner CK, Wishart JM, Horowitz M, Feinle-Bisset C, Jones KL. Effects of small intestinal glucose load on blood pressure, splanchnic blood flow, glycemia, and GLP-1 release in healthy older subjects. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1524-31. doi: 10.1152/ajpregu.00378.2010. Epub 2011 Mar 9.
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BACKGROUND
Jian ZJ, Zhou BY. Efficacy and safety of acarbose in the treatment of elderly patients with postprandial hypotension. Chin Med J (Engl). 2008 Oct 20;121(20):2054-9.
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BACKGROUND
Sasaki E, Goda K, Nagata K, Kitaoka H, Ohsawa N, Hanafusa T. Acarbose improved severe postprandial hypotension in a patient with diabetes mellitus. J Diabetes Complications. 2001 May-Jun;15(3):158-61. doi: 10.1016/s1056-8727(01)00138-6.
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BACKGROUND
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.
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BACKGROUND
Yonenaga A, Ota H, Honda M, Koshiyama D, Yagi T, Hanaoka Y, Yamamoto H, Yamaguchi Y, Iijima K, Akishita M, Ouchi Y. Marked improvement of elderly postprandial hypotension by dipeptidyl peptidase IV inhibitor. Geriatr Gerontol Int. 2013 Jan;13(1):227-9. doi: 10.1111/j.1447-0594.2012.00903.x. No abstract available.
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BACKGROUND
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
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Trahair LG, Vanis L, Gentilcore D, Lange K, Rayner CK, Horowitz M, Jones KL. Effects of variations in duodenal glucose load on blood pressure, heart rate, superior mesenteric artery blood flow and plasma noradrenaline in healthy young and older subjects. Clin Sci (Lond). 2012 Mar;122(6):271-9. doi: 10.1042/CS20110270.
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BACKGROUND
Parker BA, Sturm K, MacIntosh CG, Feinle C, Horowitz M, Chapman IM. Relation between food intake and visual analogue scale ratings of appetite and other sensations in healthy older and young subjects. Eur J Clin Nutr. 2004 Feb;58(2):212-8. doi: 10.1038/sj.ejcn.1601768.
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Ahren B. DPP-4 inhibitors. Best Pract Res Clin Endocrinol Metab. 2007 Dec;21(4):517-33. doi: 10.1016/j.beem.2007.07.005.
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Information JsP: Merck Sharp & Dohme (Australia) Pty Ltd. South Granville, NSW, Australia, 2008.
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BACKGROUND
Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab. 2011 Jan;13(1):7-18. doi: 10.1111/j.1463-1326.2010.01306.x.
Reference Type
BACKGROUND
Other Identifiers
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140916
Identifier Type: -
Identifier Source: org_study_id
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