Type 2 DiabetesPhase 2NCT01551381
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EV-077 in Type 2 Diabetic Subjects
A Phase 2 study testing EV-077 in people with Type 2 Diabetes, run by Evolva SA at 1 site in Germany.
Trial summary
The principal objective of this study is to evaluate the safety and tolerability of repeated doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral doses of EV-077-3201-2TBS on platelet function… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- EV-077
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to May 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 70 years inclusive. (NB. All females must be of non-reproductive potential, i.e. post-menopausal, post-hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- Body mass index (BMI) between 25.0 and 40.0 kg/m2 (both inclusive).
- Subjects with type 2 diabetes mellitus according to American Diabetes Association (ADA) definition for a duration of at least 3 years, on a stable therapy with oral anti-diabetic drugs (OAD) or with insulin, with or without one or two OADs or a glucagon like peptide-1 (GLP-1) agonist, or glitazones. Stable baseline therapy is defined as unchanged dose regimen for at least 3 months before administration of the study drug.
- HbA1c ≥ 6.0 and ≤ 9.0 %.
- History of hyperlipidaemia, with either elevated LDL cholesterol (>140 mg/dL) without therapy, or treatment with statins (NB. Patients on statin therapy must have a 2 week wash-out before they can enter the study).
- History of hypertension, either with systolic blood pressure levels between 140 to 160 mmHg without treatment, or treatment with ACE inhibitors or ARB, which should be stable over the previous 3 months.
Who cannot join
- Abnormal and clinically significant ECG at screening.
- Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening.
- Intake of paracetamol within 7 days before start of treatment.
- Surgery or trauma with significant blood loss within the last 3 months before administration of study drug.
- Smokers (negative cotinine test required).
- Clinically significant abnormal laboratory test results during the screening as judged by the Investigator (one retest within a week is permitted, the last result being conclusive).
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- Increased risk of bleeding, e.g. subjects with a history of deep cerebral bleeding or known defects of haemostasis with increased risk of bleeding, as judged by the Investigator.
- History of or presence of clinically significant diseases such as cancer, clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases, other major disorders as judged by the Investigator, or significant secondary diabetic complications, such as but not limited to clinically relevant peripheral neuropathy, retinopathy, diabetic foot ulcers, as judged by the Investigator.
- Supine blood pressure at screening, after resting for 5 min, of > 160 mmHg systolic or > 95 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeat measurement on a second screening visit shows values within the range, the subject can be included in the trial).
- Type 1 diabetes mellitus.
- Intake of anti-inflammatory drugs except ASA (dose 75-125mg/day stable for the previous 3 months) within 14 days before start of treatment. Steroid therapy other than topical application is not allowed.
- Any treatment with diuretics (hydrochlorothiazide is allowed)
- Liver enzymes (ALT and AST) more than 1.5 times the upper limit of normal.
- Any contraindication for a therapy with ASA such as allergy to ASA, including asthma, acute gastric ulcers, haemorrhagic diathesis, renal or liver insufficiency, or heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Controlled Study in Healthy and Type 2 Diabetic Subjects to Assess Safety, Tolerability and Pharmacokinetics of 28 Days EV-077 Treatment, and the Effects on Platelet Function, Vascular Inflammation and Oxidative Stress.
The principal objective of this study is to evaluate the safety and tolerability of repeated doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral doses of EV-077-3201-2TBS on platelet function, vascular function, vascular inflammation, vascular oxidative stress, renal function and a selection of exploratory parameters and biomarkers in type 2 diabetic subjects, as well as multiple dose pharmacokinetics in diabetic subjects.
In order to ensure the safety of the diabetic subjects, initial parts of the study will evaluate the safety and tolerability of EV-077-3201-2TBS. In Part A, the safety of different doses EV-077-3201-2TBS will be investigated in healthy subjects treated for 4 weeks. In parallel, Part B will investigate potential interactions between EV-077-3201-2TBS and ASA in healthy subjects. Part C will then investigate the safety, pharmacokinetics and pharmacodynamics of EV-077-3201-2TBS in type 2 diabetic subjects with and without concomitant ASA therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- EV-077, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- 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.
EV-077Drug
Also called EV-077-3201-2TBS
twice daily oral administration
PlaceboDrug
twice daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| EV-077 | Experimental | Oral administration Receives: Drug: EV-077 |
| Placebo | Placebo comparator | Oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Measured at Day 8 by Multiplate® with arachidonic acid as the agonist
Measured: 8 days
Secondary outcomes (4)
Platelet aggregation
Measured at multiple time points by Multiplate (using arachidonic acid, collagen, U-46619 and ADP as agonists) and the Born method (using arachidonic acid, collagen and ADP as agonists)
Measured: Days 1, 2, 8, 15, 22 and 29
Vascular inflammatory state
Changes from baseline in markers of platelet function, vascular function, vascular inflammation and vascular oxidative stress
Measured: Baseline, 2 weeks and 4 weeks
Diabetic state
Change from baseline in fasting plasma glucose and HbA1c
Measured: Baseline, 2 weeks and 4 weeks
Renal function
Change from baseline in urinary albumin excretion, creatinine clearance and exercise-induced microalbuminuria
Measured: Baseline, 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Interim review indicated that the dose selected was too high for diabetics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Jax, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551381
- Sponsor's protocol ID
- EV077/C005
- Other IDs
- 2011-003808-20
- Status last verified
- Jun 2013
- First submitted
- 8 Mar 2012
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Controlled Study in Healthy and Type 2 Diabetic Subjects to Assess Safety, Tolerability and Pharmacokinetics of 28 Days EV-077 Treatment, and the Effects on Platelet Function, Vascular Inflammation and Oxidative Stress.
- ClinicalTrials.gov ID
- NCT01551381
- Acronym / sponsor ID
- EV077/C005
- Conditions
- Type 2 Diabetes
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim review indicated that the dose selected was too high for diabetics
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Evolva SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Mar 2012 (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 principal objective of this study is to evaluate the safety and tolerability of repeated doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral doses of EV-077-3201-2TBS on platelet function, vascular function, vascular inflammation, vascular oxidative stress, renal function and a selection of exploratory parameters and biomarkers in type 2 diabetic subjects, as well as multiple dose pharmacokinetics in diabetic subjects.
In order to ensure the safety of the diabetic subjects, initial parts of the study will evaluate the safety and tolerability of EV-077-3201-2TBS. In Part A, the safety of different doses EV-077-3201-2TBS will be investigated in healthy subjects treated for 4 weeks. In parallel, Part B will investigate potential interactions between EV-077-3201-2TBS and ASA in healthy subjects. Part C will then investigate the safety, pharmacokinetics and pharmacodynamics of EV-077-3201-2TBS in type 2 diabetic subjects with and without concomitant ASA therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV-077 | Experimental | Drug: EV-077Oral administration |
| Placebo | Placebo comparator | Drug: PlaceboOral administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 18 to 70 years inclusive. (NB. All females must be of non-reproductive potential, i.e. post-menopausal, post-hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- Body mass index (BMI) between 25.0 and 40.0 kg/m2 (both inclusive).
- Subjects with type 2 diabetes mellitus according to American Diabetes Association (ADA) definition for a duration of at least 3 years, on a stable therapy with oral anti-diabetic drugs (OAD) or with insulin, with or without one or two OADs or a glucagon like peptide-1 (GLP-1) agonist, or glitazones. Stable baseline therapy is defined as unchanged dose regimen for at least 3 months before administration of the study drug.
- HbA1c ≥ 6.0 and ≤ 9.0 %.
- History of hyperlipidaemia, with either elevated LDL cholesterol (>140 mg/dL) without therapy, or treatment with statins (NB. Patients on statin therapy must have a 2 week wash-out before they can enter the study).
Key exclusion criteria (14 listed)
- Abnormal and clinically significant ECG at screening.
- Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening.
- Intake of paracetamol within 7 days before start of treatment.
- Surgery or trauma with significant blood loss within the last 3 months before administration of study drug.
- Smokers (negative cotinine test required).
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 |
|---|---|---|
| EV-077Also: EV-077-3201-2TBStwice daily oral administration | Drug | EV-077 |
| Placebotwice daily oral administration | Drug | Placebo |
Primary outcome
Platelet aggregation
Time frame: 8 days
Measured at Day 8 by Multiplate® with arachidonic acid as the agonist
4 secondary outcomes
Platelet aggregation
Time frame: Days 1, 2, 8, 15, 22 and 29
Vascular inflammatory state
Time frame: Baseline, 2 weeks and 4 weeks
Diabetic state
Time frame: Baseline, 2 weeks and 4 weeks
Renal function
Time frame: Baseline, 2 weeks and 4 weeks
Results and safety
The study was stopped early (reason given: Interim review indicated that the dose selected was too high for diabetics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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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.
Thomas Jax, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EV-077 in people with Type 2 Diabetes, run by Evolva SA at 1 site in Germany.
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 6 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: stopped early, as of the sponsor's last update on 17 Jun 2013. 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 Germany. 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 was stopped early (reason given: Interim review indicated that the dose selected was too high for diabetics). Results are not available in the source record.
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?
Platelet aggregation (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2013.