Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes

NCT02324010 | Completed Phase 2

• 1 other identifier: 140916
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis; Diabetes Mellitus

Keywords

gastric emptying; glycemia; appetite; incretin hormones

Outcome Measures

Primary Outcomes (1)

• Gastric emptying

  Gastric retention (percent in the total stomach)

  3 hours per gastric emptying study (i.e. 6 hours)

Secondary Outcomes (9)

• Glycaemia

  4 hours during each gastric empty study (i.e. 8 hours)

• Gastrointestinal hormone release

  4 hours during each gastric empty study (i.e. 8 hours)

• Intragastric meal distribution

  3 hours during each gastric empty study (i.e. 6 hours)

• Blood pressure

  4.5 hours during each gastric empty study (i.e. 9 hours)

• Heart rate

  4.5 hours during each gastric empty study (i.e. 9 hours)

Study Arms (2)

Sitaglipltin (100mg)

EXPERIMENTAL

Active drug (sitagliptin)

Drug: Placebo

Placebo (sugar pill)

PLACEBO COMPARATOR

Inactive drug (placebo)

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

100mg mane for 2 days

Also known as: MK-0431-075, Januvia

Placebo (sugar pill)

Placebo DRUG

Inactive drug (Placebo)

Also known as: Sugar pill

Sitaglipltin (100mg)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Adelaide Hospital: lead

Study Sites (1)

University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (32)

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• 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.

  PMID: 19707284 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.

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  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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• 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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• 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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• 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.

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  PMID: 9505868 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.

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• Information JsP: Merck Sharp & Dohme (Australia) Pty Ltd. South Granville, NSW, Australia, 2008.

  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.

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MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Sugars

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Carbohydrates

Study Officials

• Karen L Jones, DAppSci, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 24, 2014
• Study Start: July 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

AU (1)