Diabetes MellitusPhase 1/2LixiNCT02308254
Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People
A Phase 1/2 study testing Lixisenatide in people with Diabetes Mellitus and Gastroparesis, run by Royal Adelaide Hospital at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Gastroparesis
- What is being tested?
- Lixisenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2013to Apr 2016
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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:
- Alanine aminotransferase (ALT) 0 - 55 U/L
- Alkaline phosphatase 30 - 110 U/L
- Aspartate transaminase 0 - 45 U/L
- Amylase and/or lipase >3 x ULN
- Bilirubin 6 - 24 mmol/L
Show all 18Show fewer
- Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, 5000
Karen L Jones, PhD, +61 8 8222 5394 ext. 25394, karen.jones@adelaide.edu.au
Michael Horowitz, PhD, FRACP, +61 8 8222 4327 ext. 24327, michael.horowitz@adelaide.edu.au
About this study
Official title: Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Gastroparesis
- Being tested
- Lixisenatide, Placebo
- Keywords
- Blood pressure, Gastric emptying, Glycemia, Appetite, Incretin Hormones, Superior mesenteric artery blood low
- Medical subject headings
- Diabetes Mellitus, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixisenatideDrug
Also called Lyxumia
Abdominal administration
PlaceboDrug
Also called Dummy
Abdominal administration
| Study group | Role | What they receive |
|---|---|---|
| Lixisenatide | Active comparator | Lixisenatide: 10 mcg, one subcutaneous injection dose Receives: Drug: Lixisenatide |
| Placebo | Placebo comparator | Matching placebo: one subcutaneous injection dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Measured: 4.5 hours per study
Secondary outcomes (3)
Heart rate
Heart rate (beats per minute)
Measured: 4.5 hours per study
Gastric emptying rate
Gastric retention (percent in the total stomach)
Measured: 3 hours per study
Blood glucose concentration
Blood glucose (mmol/L)
Measured: 3 hours per study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Adelaide Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Karen Jones, Royal Adelaide Hospital
- Investigators
- Karen L Jones, PhD, Principal investigator, University of Adelaide, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308254
- Sponsor's protocol ID
- 130419
- Acronym
- Lixi
- Status last verified
- Oct 2015
- First submitted
- 3 Nov 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10764704Brennan IM, Feltrin KL, Horowitz M, Smout AJ, Meyer JH, Wishart J, Feinle-Bisset C. Evaluation of interactions between CCK and GLP-1 in their effects on appetite, energy intake, and antropyloroduodenal motility in healthy men. Am J Physiol Regul Integr Comp Physiol. 2005 Jun;288(6):R1477-85. doi: 10.1152/ajpregu.00732.2004. Epub 2005 Feb 3.
PubMed 15695321Nauck 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 9374685Little TJ, Pilichiewicz AN, Russo A, Phillips L, Jones KL, Nauck MA, Wishart J, Horowitz M, Feinle-Bisset C. Effects of intravenous glucagon-like peptide-1 on gastric emptying and intragastric distribution in healthy subjects: relationships with postprandial glycemic and insulinemic responses. J Clin Endocrinol Metab. 2006 May;91(5):1916-23. doi: 10.1210/jc.2005-2220. Epub 2006 Feb 21.
PubMed 16492694Delgado-Aros S, Kim DY, Burton DD, Thomforde GM, Stephens D, Brinkmann BH, Vella A, Camilleri M. Effect of GLP-1 on gastric volume, emptying, maximum volume ingested, and postprandial symptoms in humans. Am J Physiol Gastrointest Liver Physiol. 2002 Mar;282(3):G424-31. doi: 10.1152/ajpgi.2002.282.3.G424.
PubMed 11841992Horowitz M, Nauck MA. To be or not to be--an incretin or enterogastrone? Gut. 2006 Feb;55(2):148-50. doi: 10.1136/gut.2005.071787.
PubMed 16407380Horowitz 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 23423907Riddle 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).
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).
Ahrén B, Dimas L, Miossec P, Saubado S, Aronson R. Efficacy and safety of lixisenatide QD morning and evening injections vs placebo in T2DM inadequately controlled on metformin (GetGoal-M). Oral presentation at the 21st World Diabetes Congress, Dubai, UAE, 8 December 2011 (Abstract 0-0591).
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).
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.
PubMed 23627775Rosenstock 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).
Bolli G, Munteanu M, Dotsenko S, Niemoeller E, Boka G, Hanefield M. Efficacy and safety of lixisenatide once-daily versus placebo in patients with T2DM insufficiently controlled on metformin (GetGoal-F1). 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 784).
Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. 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). Diabetes Care. 2012 Jun;35(6):1225-31. doi: 10.2337/dc11-1935. Epub 2012 Mar 19.
PubMed 22432104
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02308254
- Acronym / sponsor ID
- Lixi / 130419
- Conditions
- Diabetes Mellitus, Gastroparesis
- Keywords
- Blood pressure, Gastric emptying, Glycemia, Appetite, Incretin Hormones, Superior mesenteric artery blood low
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Adelaide HospitalUniversity, hospital or other
- Collaborators
- Sanofi, National Health and Medical Research Council, Australia
- Study start
- Nov 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixisenatide | Active comparator | Drug: LixisenatideLixisenatide: 10 mcg, one subcutaneous injection dose |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo: one subcutaneous injection dose |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects:
- Type 2 Diabetic Patients:
Key exclusion criteria (18 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LixisenatideAlso: LyxumiaAbdominal administration | Drug | Lixisenatide |
| PlaceboAlso: DummyAbdominal administration | Drug | Placebo |
Primary outcome
Blood Pressure
Time frame: 4.5 hours per study
Systolic and diastolic blood pressure (mmHg)
3 secondary outcomes
Heart rate
Time frame: 4.5 hours per study
Gastric emptying rate
Time frame: 3 hours per study
Blood glucose concentration
Time frame: 3 hours per study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Background: PubMed 10764704Schirra 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.
- Background: PubMed 15695321Brennan IM, Feltrin KL, Horowitz M, Smout AJ, Meyer JH, Wishart J, Feinle-Bisset C. Evaluation of interactions between CCK and GLP-1 in their effects on appetite, energy intake, and antropyloroduodenal motility in healthy men. Am J Physiol Regul Integr Comp Physiol. 2005 Jun;288(6):R1477-85. doi: 10.1152/ajpregu.00732.2004. Epub 2005 Feb 3.
- Background: PubMed 9374685Nauck 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.
- Background: PubMed 16492694Little TJ, Pilichiewicz AN, Russo A, Phillips L, Jones KL, Nauck MA, Wishart J, Horowitz M, Feinle-Bisset C. Effects of intravenous glucagon-like peptide-1 on gastric emptying and intragastric distribution in healthy subjects: relationships with postprandial glycemic and insulinemic responses. J Clin Endocrinol Metab. 2006 May;91(5):1916-23. doi: 10.1210/jc.2005-2220. Epub 2006 Feb 21.
- Background: PubMed 11841992Delgado-Aros S, Kim DY, Burton DD, Thomforde GM, Stephens D, Brinkmann BH, Vella A, Camilleri M. Effect of GLP-1 on gastric volume, emptying, maximum volume ingested, and postprandial symptoms in humans. Am J Physiol Gastrointest Liver Physiol. 2002 Mar;282(3):G424-31. doi: 10.1152/ajpgi.2002.282.3.G424.
- Background: PubMed 16407380Horowitz M, Nauck MA. To be or not to be--an incretin or enterogastrone? Gut. 2006 Feb;55(2):148-50. doi: 10.1136/gut.2005.071787.
- Background: PubMed 23423907Horowitz 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.
- BackgroundRiddle 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).
- BackgroundRosenstock 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).
- BackgroundAhrén B, Dimas L, Miossec P, Saubado S, Aronson R. Efficacy and safety of lixisenatide QD morning and evening injections vs placebo in T2DM inadequately controlled on metformin (GetGoal-M). Oral presentation at the 21st World Diabetes Congress, Dubai, UAE, 8 December 2011 (Abstract 0-0591).
- BackgroundRatner 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).
- Background: PubMed 23627775Pinget 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Jones, PhD principal investigator
University of Adelaide, Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lixisenatide in people with Diabetes Mellitus and Gastroparesis, 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Oct 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachael S Tippett, BSc Honours (8222 2915 ext. 2915, rachael.tippett@adelaide.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 4.5 hours per study). 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 NCT02308254, which also lists 38 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 29 Oct 2015.