DiabetesPhase 1APELINS-2NCT02724566
Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
A Phase 1 study testing apelin in people with Diabetes, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- apelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Apr 2017
- Phase
- Phase 1
- 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
- Clinical diagnosis of type2 diabetes
- Body Mass Index between 27 and 33 kg / cm ²
- HbA1c < 8.5%
- Non-pathological Electrocardiogram
- Heart rate between 50 and 80 beats per minute at rest.
- Complete Blood Count (CBC) with no significant anomaly in terms of the investigator..
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- Serum electrolytes without clinically significant abnormalities in terms of the investigator.
- Liver function tests without clinically significant abnormalities in terms of the investigator
- Renal function tests without clinically significant abnormalities in terms of the investigator
- Good peripheral vein (forearm and back of the hand).
- Agreement to participate in the establishment of a serum bank.
- Ability to sign informed consent.
- Affiliation to a social security scheme
Who cannot join
- Secondary prevention of cardio-vascular disease
- Insulin therapy or Glucagon Like Peptid 1 (GLP-1) analogs therapy in the 6 months before inclusion.
- Risk factor, treatment or electrocardiogram as recommended by International Conference on Harmonization (ICH) E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
- Repeated a QTc interval> 450 ms measurement
- Risk factor for torsade de pointes: myocardial infarction, hypokalemia, family history of long QT syndrome
- Personal history of cancer.
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- Positive HIV serology.
- Hepatitis B serology positive.
- Positive hepatitis C serology.
- Cognitive impairment or mental illness (at the discretion of the investigator).
- Chronic excessive alcohol consumption (consumption > 30g/day or 210g/week).
- Person under judicial protection, guardianship.
- Subject with a resting systolic blood pressure greater than 140 mm Hg and diastolic blood pressure greater than 90 mmHg
- Smoking more than 10 cigaret per day and can not be interrupted for 24 hours.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospitals of Toulouse (Rangueil)
Toulouse, Midi-Pyrénées, 31059
About this study
Official title: Influence of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.
Read the detailed description
Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method. The hypothesis of the investigators is that a continuous (pyr1)-apelin-13 infusion improves insulin sensitivity of type 2 diabetic patients compared to placebo infusion.
This study could bring new elements for understanding the pathophysiology of insulin resistance and type 2 diabetes mellitus in humans and could lead to the development of innovative therapies in type 2 diabetes mellitus.
- Conditions
- Diabetes
- Being tested
- apelin, placebo
- Keywords
- Type 2 diabetic volunteers
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apelinDrug
Also called [pyr1]-apelin-13 infusion
Assessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone).
placeboDrug
2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin
| Study group | Role | What they receive |
|---|---|---|
| Apelin then Placebo | Other | First clamp during which an apelin infusion will be administered followed by a wash-out period and then, a second clamp in which a placebo infusion will be administered Receives: Drug: apelin; Drug: placebo |
| Placebo then Apelin | Other | First clamp during which a placebo infusion will be administered followed by a wash-out period and then, a second clamp in which an apelin infusion will be administered Receives: Drug: apelin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta between Glucose Infusion Rate
Difference between glucose infusion rate measured during investigational product infusion (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and basal glucose infusion rate (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes).
Measured: 240 minutes
Secondary outcomes (8)
Measure of M-value (a glucose physiological parameter)
Difference between value of product time (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and value of basal (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes).
Measured: 240 minutes
systolic blood pressure and diastolic blood pressure
Measured: 240 minutes
heart rate
Measured: 240 minutes
Measure of QTc interval with electrocardiogram examination
Measured: 240 minutes
Clinic sign of apelin intolerance
Measured: 240 minutes
Dosage of plasma proteins
A kinetic is realized with samples at 0, 15, 30, 45, 60, 75, 90, 100, 110, 120, 135, 150, 165, 180, 195, 200, 220, 230 and 240 minutes
Measured: 240 minutes
Clinic sign of apelin allergy
Modification in physiological parameters
Measured: 240 minutes
Clinic sign of apelin toxicity
Modification in physiological parameters
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
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 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Société Francophone du Diabète
- Responsible party
- Sponsor
- Investigators
- Pierre Gourdy, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724566
- Sponsor's protocol ID
- 15 7783 03
- Acronym
- APELINS-2
- Status last verified
- Aug 2017
- First submitted
- 18 Mar 2016
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.
PubMed 28681996
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
- ClinicalTrials.gov ID
- NCT02724566
- Acronym / sponsor ID
- APELINS-2 / 15 7783 03
- Conditions
- Diabetes
- Keywords
- Type 2 diabetic volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Société Francophone du Diabète
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 31 Mar 2016 (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.
Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.
Detailed description
Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method. The hypothesis of the investigators is that a continuous (pyr1)-apelin-13 infusion improves insulin sensitivity of type 2 diabetic patients compared to placebo infusion.
This study could bring new elements for understanding the pathophysiology of insulin resistance and type 2 diabetes mellitus in humans and could lead to the development of innovative therapies in type 2 diabetes mellitus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apelin then Placebo | Other | Drug: apelin, Drug: placeboFirst clamp during which an apelin infusion will be administered followed by a wash-out period and then, a second clamp in which a placebo infusion will be administered |
| Placebo then Apelin | Other | Drug: apelin, Drug: placeboFirst clamp during which a placebo infusion will be administered followed by a wash-out period and then, a second clamp in which an apelin infusion will be administered |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical diagnosis of type2 diabetes
- Body Mass Index between 27 and 33 kg / cm ²
- HbA1c < 8.5%
- Non-pathological Electrocardiogram
- Heart rate between 50 and 80 beats per minute at rest.
Key exclusion criteria (14 listed)
- Secondary prevention of cardio-vascular disease
- Insulin therapy or Glucagon Like Peptid 1 (GLP-1) analogs therapy in the 6 months before inclusion.
- Risk factor, treatment or electrocardiogram as recommended by International Conference on Harmonization (ICH) E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
- Repeated a QTc interval> 450 ms measurement
- Risk factor for torsade de pointes: myocardial infarction, hypokalemia, family history of long QT syndrome
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 |
|---|---|---|
| apelinAlso: [pyr1]-apelin-13 infusionAssessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone). | Drug | Apelin then Placebo, Placebo then Apelin |
| placebo2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin | Drug | Apelin then Placebo, Placebo then Apelin |
Primary outcome
Delta between Glucose Infusion Rate
Time frame: 240 minutes
Difference between glucose infusion rate measured during investigational product infusion (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and basal glucose infusion rate (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes).
8 secondary outcomes
Measure of M-value (a glucose physiological parameter)
Time frame: 240 minutes
systolic blood pressure and diastolic blood pressure
Time frame: 240 minutes
heart rate
Time frame: 240 minutes
Measure of QTc interval with electrocardiogram examination
Time frame: 240 minutes
Clinic sign of apelin intolerance
Time frame: 240 minutes
Dosage of plasma proteins
Time frame: 240 minutes
Clinic sign of apelin allergy
Time frame: 240 minutes
Clinic sign of apelin toxicity
Time frame: 240 minutes
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 10 Dec 2025.
- Results publication: PubMed 28681996Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.
- Individual participant dataSharing planned: No
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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.
Pierre Gourdy, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing apelin in people with Diabetes, run by University Hospital, Toulouse at 1 site in France.
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 13 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 10 Dec 2025. 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 France. 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. 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 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.
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?
Delta between Glucose Infusion Rate (time frame: 240 minutes). 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 NCT02724566, 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 10 Dec 2025.