Type 2 DiabetesPhase 4NCT02049034
Lixisenatide-The Effects on Glucose and Lipid Metabolism in Type 2 Diabetes
A Phase 4 study testing Lixisenatide in people with Type 2 Diabetes, run by University of Surrey at 1 site in United Kingdom.
Trial summary
Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Type 2 Diabetes
- 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
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 4
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes inadequately controlled by metformin.
- Stable diabetes management over last 3 months: metformin dose unchanged. HbA1c not known to have changed by >0.5% over 3 months.
- Caucasian
- Male
- 40-65 years (inclusive)
- HbA1c 7.5-9.5% (inclusive)
Show all 10Show fewer
- BMI 27-40 kg/m2 (inclusive)
- Able and willing to self-administer placebo/lixisenatide injection
- Able and willing to perform self-blood glucose monitoring.
- Able and willing to wear a Continuous Glucose Monitoring System (CGMS) for 3 days
Who cannot join
- Subjects treated with insulin, any oral hypoglycaemic agents (OHA) (other than metformin), any insulin secretagogue or Thiazolidinediones (TZDs)
- A history of heavy alcohol use (>12 to 15 g of alcohol per day)
- Arteriopathy
- History of significant coronary artery disease (myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel)
- Ischemic cerebrovascular disease, including:
- History of ischemic stroke.
Show all 23Show fewer
- History of carotid arterial disease as documented by ≥ 50 % stenosis documented by carotid ultrasound, magnetic resonance imaging or angiography, with or without neurological sequelae.
- Atherosclerotic peripheral arterial disease, as documented by history of amputation due to vascular disease; history of surgical or percutaneous revascularization procedure; current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index less than 0.9
- Hepatic disease: alanine transaminase (ALT) >3 times upper limit of normal (ULN)
- Renal disease: estimated glomerular filtration rate (Cockroft-Gault equation) less than 40ml/minute.
- Subjects receiving fibrates or weight reducing drugs
- Mental incapacity
- Unwillingness or a language barrier precluding adequate understanding or co-operation
- Fasting plasma triglycerides >4.0 mmol/l
- Systolic blood pressure >160 mmHg on 2 occasions, measured at least 10-minutes apart
- Screening amylase and/or lipase > 3 times ULN or P-calcitonin ≥20 pg/ml (5.9 pmol/L).
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
- Any stomach/gastric surgery other than minor endoscopic procedures such as peptic ulcer injection
- Allergic reaction to any GLP-1 receptor agonist or to metacresol.
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
- Current smokers
- Subject enrolled in another experimental protocol which involves the use of an investigational drug or device
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Surrey FHMS Diabetes and Metabolic Medicine
Guildford, Surrey, GU2 7WG
About this study
Official title: The Effect of Lixisenatide on Postprandial Lipid and Glucose Metabolism in Patients with Type 2 Diabetes
Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an increased risk of cardiovascular disease, is a feature of type 2 diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor signalling is required for the control of postprandial lipoprotein synthesis and secretion in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor antagonist increased apoB-48 TRL production.
This study will investigate the effect of the GLP-1 analogue lixisenatide compared with placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12 patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid meal will also be investigated using stable isotope methodology. Gastric emptying and post heparin LPL activity will be measured.
The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a result of an improvement in insulin sensitivity.
Read the detailed description
GLP-1 analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an increased risk of cardiovascular disease, is a feature of type 2 diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor signalling is required for the control of postprandial lipoprotein synthesis and secretion in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor antagonist increased apoB-48 TRL production.
This study will investigate the effect of the GLP-1 analogue lixisenatide compared with placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12 patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study (Visits 4 and 8) by labelling apoB-100 and apoB-48 with 1-13C leucine (infusion for 8 hours) and by labelling triglycerides with [1,1,2,3,3-2H5 ]glycerol (as a bolus injection) and 13C triolein. Blood samples will be taken for 4 hours prior to during the 8 hr isotopic infusion to measure the enrichment of apoB-100 and apoB-48 with 1-13C leucine by gas chromatography mass spectrometry.
At Visits 3 and 7, glucose flux in response to a mixed fluid meal containing U-13C glucose will be investigated. Endogenous glucose production will also be measured by infusing [6,6-2H2] glucose for 6hours.
Gastric emptying will be measured by acetaminophen (1000 mg) absorption. Patients will also receive heparin (50U/kg) at the end of the study after 15 minutes a blood sample will be taken to determine post heparin lipoprotein lipase (LPL) activity.
During the study the patients will be asked to monitor their blood glucose for three days with continuous glucose monitoring and to fill in a 7 day food diary.
The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a result of an improvement in insulin sensitivity.
ii] lixisenatide will reduce postprandial triglycerides due to a decrease in chylomicron production as a result of a direct effect on enterocyte chylomicron assembly and will also reduce VLDL secretion from the liver as a result of an improvement in insulin sensitivity.
- Conditions
- Type 2 Diabetes
- Being tested
- Lixisenatide, Placebo
- Keywords
- GLP-1 agonist, Lixisenatide, Postprandial glucose metabolism, Postprandial lipid metabolism, Gastric emptying, Lipoprotein lipase activity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixisenatideOther
Also called GLP-1 agonist, Lyxumia
Lixisenatide and placebo are considered as investigational medicinal product (IMP). Metformin is not considered an investigational product but concomitant allowed antidiabetic medications.
Lixisenatide is supplied as disposable pre-filled pen for subcutaneous injection: 10mcg Lixisenatide green pens; 20 mcg Lixisenatide purple pens. Dose titration-10mcg Lixisenatide for 14 days, 20 mcg for 14 days.
PlaceboOther
Placebo for lixisenatide is supplied as green and purple colored disposable pen-injectors containing 3 mL of a sterile aqueous solution.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for lixisenatide is supplied as green and purple colored disposable pen-injectors containing 3 mL of a sterile aqueous solution. Receives: Other: Lixisenatide; Other: Placebo |
| Lixisenatide | Experimental | Lixisenatide and placebo are considered as investigational medicinal product (IMP). Metformin is not considered an investigational product but concomitant allowed antidiabetic medications.
Lixisenatide is supplied as disposable pre-filled pen for subcutaneous injection: 10mcg Lixisenatide green pens; 20 mcg Lixisenatide purple pens. Dose titration-10mcg Lixisenatide for 14 days, 20 mcg for 14 days. Receives: Other: Lixisenatide; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose kinetics
The study is a double blind cross over study comparing placebo injection with lixisenatide injection. The results will not be known until the investigator is unblinded. An intravenous infusion of [6,6 2H2] glucose will enable the quantification of endogenous hepatic glucose output while addition of [U13C] glucose to a mixed meal will enable the calculation of the contribution of meal derived glucose to postprandial glucose. Enrichment of plasma samples with 2H2 glucose and 13C glucose will be measured by gas chromatography mass spectroscopy (GCMS). Glucose uptake during the postprandial period will then be determined from these measures of glucose output and the glucose concentration at each time point. During this study, gastric emptying will be measured by oral administration of 1000mg acetaminophen.
Measured: Two years
Secondary outcomes (1)
Postprandial and intestinal triglyceride-rich lipoproteins (TRL) kinetics
Triglyceride kinetics in TRLs will be measured by intravenous injection of isotopically labelled glycerol which will be incorporated into nascent triglyceride molecules which is then incorporated into TRL particles (endogenous pathway) and oral administration of 13C triolein which will be incorporated as fatty acids into triglycerides and then become integrated into lipoprotein particles (exogenous pathway). The study uses a feeding protocol which maintains a steady state triglyceride concentration throughout the study. Repeated blood samples will be taken over many hours after administration of the tracers. Hepatic TRL (apoB-100) will be separated from intestinal TRL (ApoB48) using an immunoaffinity method. Measuring the glycerol and 13C oleate enrichments of the triglyceride isolated from lipoproteins, will allow the calculation of the production and clearance rates of triglycerides in both hepatic and intestinal TRLs.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo to IMP (lixisenatide) or IMP (lixisenatide) to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- David Russell-Jones, MBBS PhD, Study chair, Royal Surrey County Hospital NHS Foundation TrustMargot Umpleby, BA, PhD, Study director, University of SurreyMartin Whyte, MBBS, PhD, Principal investigator, University of SurreyFariba Shojaee-Moradie, BSc, PhD, Principal investigator, Royal Surrey County Hospital & University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049034
- Sponsor's protocol ID
- LIXISL06684
- Other IDs
- 2013-002826-22
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2013
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make the individual participant data available, however the averaged data has been published .
Publications
Whyte MB, Shojaee-Moradie F, Sharaf SE, Jackson NC, Fielding B, Hovorka R, Mendis J, Russell-Jones D, Umpleby AM. Lixisenatide Reduces Chylomicron Triacylglycerol by Increased Clearance. J Clin Endocrinol Metab. 2019 Feb 1;104(2):359-368. doi: 10.1210/jc.2018-01176.
PubMed 30215735
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lixisenatide on Postprandial Lipid and Glucose Metabolism in Patients with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02049034
- Acronym / sponsor ID
- LIXISL06684
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1 agonist, Lixisenatide, Postprandial glucose metabolism, Postprandial lipid metabolism, Gastric emptying, Lipoprotein lipase activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Jan 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.
Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an increased risk of cardiovascular disease, is a feature of type 2 diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor signalling is required for the control of postprandial lipoprotein synthesis and secretion in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor antagonist increased apoB-48 TRL production.
This study will investigate the effect of the GLP-1 analogue lixisenatide compared with placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12 patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid meal will also be investigated using stable isotope methodology. Gastric emptying and post heparin LPL activity will be measured.
The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a result of an improvement in insulin sensitivity.
Detailed description
GLP-1 analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an increased risk of cardiovascular disease, is a feature of type 2 diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor signalling is required for the control of postprandial lipoprotein synthesis and secretion in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor antagonist increased apoB-48 TRL production.
This study will investigate the effect of the GLP-1 analogue lixisenatide compared with placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12 patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study (Visits 4 and 8) by labelling apoB-100 and apoB-48 with 1-13C leucine (infusion for 8 hours) and by labelling triglycerides with [1,1,2,3,3-2H5 ]glycerol (as a bolus injection) and 13C triolein. Blood samples will be taken for 4 hours prior to during the 8 hr isotopic infusion to measure the enrichment of apoB-100 and apoB-48 with 1-13C leucine by gas chromatography mass spectrometry.
At Visits 3 and 7, glucose flux in response to a mixed fluid meal containing U-13C glucose will be investigated. Endogenous glucose production will also be measured by infusing [6,6-2H2] glucose for 6hours.
Gastric emptying will be measured by acetaminophen (1000 mg) absorption. Patients will also receive heparin (50U/kg) at the end of the study after 15 minutes a blood sample will be taken to determine post heparin lipoprotein lipase (LPL) activity.
During the study the patients will be asked to monitor their blood glucose for three days with continuous glucose monitoring and to fill in a 7 day food diary.
The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a result of an improvement in insulin sensitivity.
ii] lixisenatide will reduce postprandial triglycerides due to a decrease in chylomicron production as a result of a direct effect on enterocyte chylomicron assembly and will also reduce VLDL secretion from the liver as a result of an improvement in insulin sensitivity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo to IMP (lixisenatide) or IMP (lixisenatide) to placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Lixisenatide, Other: PlaceboPlacebo for lixisenatide is supplied as green and purple colored disposable pen-injectors containing 3 mL of a sterile aqueous solution. |
| Lixisenatide | Experimental | Other: Lixisenatide, Other: PlaceboLixisenatide and placebo are considered as investigational medicinal product (IMP). Metformin is not considered an investigational product but concomitant allowed antidiabetic medications. Lixisenatide is supplied as disposable pre-filled pen for subcutaneous injection: 10mcg Lixisenatide green pens; 20 mcg Lixisenatide purple pens. Dose titration-10mcg Lixisenatide for 14 days, 20 mcg for 14 days. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with type 2 diabetes inadequately controlled by metformin.
- Stable diabetes management over last 3 months: metformin dose unchanged. HbA1c not known to have changed by >0.5% over 3 months.
- Caucasian
- Male
- 40-65 years (inclusive)
Key exclusion criteria (23 listed)
- Subjects treated with insulin, any oral hypoglycaemic agents (OHA) (other than metformin), any insulin secretagogue or Thiazolidinediones (TZDs)
- A history of heavy alcohol use (>12 to 15 g of alcohol per day)
- Arteriopathy
- Hepatic disease: alanine transaminase (ALT) >3 times upper limit of normal (ULN)
- Renal disease: estimated glomerular filtration rate (Cockroft-Gault equation) less than 40ml/minute.
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: GLP-1 agonist, LyxumiaLixisenatide and placebo are considered as investigational medicinal product (IMP). Metformin is not considered an investigational product but concomitant allowed antidiabetic medications. Lixisenatide is supplied as disposable pre-filled pen for subcutaneous injection: 10mcg Lixisenatide green pens; 20 mcg Lixisenatide purple pens. Dose titration-10mcg Lixisenatide for 14 days, 20 mcg for 14 days. | Other | Lixisenatide, Placebo |
| PlaceboPlacebo for lixisenatide is supplied as green and purple colored disposable pen-injectors containing 3 mL of a sterile aqueous solution. | Other | Lixisenatide, Placebo |
Primary outcome
Postprandial glucose kinetics
Time frame: Two years
The study is a double blind cross over study comparing placebo injection with lixisenatide injection. The results will not be known until the investigator is unblinded. An intravenous infusion of [6,6 2H2] glucose will enable the quantification of endogenous hepatic glucose output while addition of [U13C] glucose to a mixed meal will enable the calculation of the contribution of meal derived glucose to postprandial glucose. Enrichment of plasma samples with 2H2 glucose and 13C glucose will be measured by gas chromatography mass spectroscopy (GCMS). Glucose uptake during the postprandial period will then be determined from these measures of glucose output and the glucose concentration at each time point. During this study, gastric emptying will be measured by oral administration of 1000mg acetaminophen.
1 secondary outcome
Postprandial and intestinal triglyceride-rich lipoproteins (TRL) kinetics
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 30215735Whyte MB, Shojaee-Moradie F, Sharaf SE, Jackson NC, Fielding B, Hovorka R, Mendis J, Russell-Jones D, Umpleby AM. Lixisenatide Reduces Chylomicron Triacylglycerol by Increased Clearance. J Clin Endocrinol Metab. 2019 Feb 1;104(2):359-368. doi: 10.1210/jc.2018-01176.
- Whyte MB, Shojaee-Moradie F, Sharaf SE, et al. Lixisenatide Reduces Chylomicron Triacylglycerol by Increased Clearance. J Clin Endocrinol Metab. 2019;104(2):359-368.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make the individual participant data available, however the averaged data has been published .
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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.
David Russell-Jones, MBBS PhD study chair
Royal Surrey County Hospital NHS Foundation Trust
Margot Umpleby, BA, PhD study director
University of Surrey
Martin Whyte, MBBS, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lixisenatide in people with Type 2 Diabetes, run by University of Surrey at 1 site in United Kingdom.
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 10 inclusion and 23 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 16 Dec 2024. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postprandial glucose kinetics (time frame: Two years). 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 NCT02049034, which also lists 1 linked publication.
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 16 Dec 2024.