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GastroparesisPhase 2NCT02324010

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

A Phase 2 study testing Sitagliptin in people with Gastroparesis and Diabetes Mellitus, run by Royal Adelaide Hospital at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Gastroparesis, Diabetes Mellitus
What is being tested?
Sitagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteAustralia
Study dates
Jul 2015to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying

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.

Read the detailed description

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.

Being tested
Sitagliptin, Placebo
Keywords
gastric emptying, glycemia, appetite, incretin hormones
Medical subject headings
Gastroparesis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitagliptinDrug

    Also called MK-0431-075, Januvia

    100mg mane for 2 days

  • PlaceboDrug

    Also called Sugar pill

    Inactive drug (Placebo)

Study groups in NCT02324010
Study groupRoleWhat they receive
Sitaglipltin (100mg)ExperimentalActive drug (sitagliptin)
Receives: Drug: Placebo
Placebo (sugar pill)Placebo comparatorInactive drug (placebo)
Receives: Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric emptying

    Gastric retention (percent in the total stomach)

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

Secondary outcomes (9)

  1. Glycaemia

    blood glucose (mmol/L) and plasma insulin (mU/L)

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

  2. Gastrointestinal hormone release

    GLP-1, GIP, C-peptide, 3-OMG

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

  3. Intragastric meal distribution

    percent retention in the proximal and distal stomach

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

  4. Blood pressure

    systolic and diastolic blood pressure (mmHg)

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

  5. Heart rate

    Heart rate (beats per minute)

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

  6. Splanchnic blood flow

    Doppler ultrasound of superior mesenteric artery flow (ml/min)

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

  7. Cardiac output

    Finapres (L)

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

  8. Stroke volume

    Finapres (mL)

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

  9. Appetite

    visual analogue questionnaire to assess hunger, fullness, desire to eat (mm)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02324010
Sponsor's protocol ID
140916
Status last verified
Jul 2017
First submitted
16 Dec 2014
Last updated
7 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24060702

  • 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.

    PubMed 17007012

  • 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.

    PubMed 8405758

  • 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.

    PubMed 8862300

  • 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.

    PubMed 23423907

  • 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.

    PubMed 17498508

  • 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.

    PubMed 14228531

  • 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.

    PubMed 3514343

  • 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.

    PubMed 8423228

  • 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.

    PubMed 9374685

  • 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.

    PubMed 19707284

  • 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.

    PubMed 22738299

  • 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.

    PubMed 17303799

  • 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.

  • 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.

    PubMed 23359361

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitagliptin in people with Gastroparesis and Diabetes Mellitus, run by Royal Adelaide Hospital at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric emptying (time frame: 3 hours per gastric emptying study (i.e. 6 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02324010, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.

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