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Trial · Interventional

Status unknownPhase 1/2Registry data

Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

Short name Lixi

NCTNCT02308254 (opens ClinicalTrials.gov in a new tab)Other id130419
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 1/2
Enrollment
30 participants (estimated)
Sponsor
Royal Adelaide Hospital · Other
Design
Randomized · Double masking
Countries
1 country

Australia

Start
Nov 2013
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
First posted
4 Dec 2014 (estimated)
Last update posted
29 Oct 2015 (estimated)
Conditions
Diabetes Mellitus · Gastroparesis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 1/2

    Lixi

    NCT02308254

    Nov 2013 to est. Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LixisenatideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Lixisenatide

    Lixisenatide: 10 mcg, one subcutaneous injection dose

  • Placebo comparator

    Placebo

    Matching placebo: one subcutaneous injection dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Blood Pressure

    Time frame · 4.5 hours per study

    Registry description

    Systolic and diastolic blood pressure (mmHg)

Secondary outcomes(3)

  1. Heart rate

    Time frame · 4.5 hours per study

    Registry description

    Heart rate (beats per minute)

  2. Gastric emptying rate

    Time frame · 3 hours per study

    Registry description

    Gastric retention (percent in the total stomach)

  3. Blood glucose concentration

    Time frame · 3 hours per study

    Registry description

    Blood glucose (mmol/L)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2022

5 results

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.

Marathe et al. 2022Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 7

PMID 35460043PMC9174387DOI 10.1007/s13300-022-01258-4PUB-35460043

Free to read · publisher termsCC BY-NC5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2013

8 results

Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).

Pinget et al. 2013Diabetes, obesity & metabolismcited by 119

PMID 23627775DOI 10.1111/dom.12121PUB-23627775

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2012

14 results

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).

Fonseca et al. 2012Diabetes carecited by 167

PMID 22432104PMC3357248DOI 10.2337/dc11-1935PUB-22432104

Free to read · publisher termsCC BY-NC-ND14 results
Read at sourceSee results (14)

Indexing hint: Animal study · 1996

7 results

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.

Barragán et al. 1996Regulatory peptidescited by 89

PMID 8952007DOI 10.1016/s0167-0115(96)00113-9PUB-08952007

Full text at the publisher7 results
Publisher pageSee results (7)

More studies

1 study on this page

Indexing hint: Review · 2009

Efficacy and safety of incretin based therapies: clinical trial data.

White et al. 2009Journal of the American Pharmacists Association : JAPhAcited by 48

PMID 19801363DOI 10.1331/japha.2009.09079PUB-19801363

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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: 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

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