Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT02113163
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
A Phase 1 study testing Metformin Eicosapentaenoate and Metformin HCl and Vascepa in people with Diabetes Mellitus, Non-Insulin-Dependent and Hypertriglyceridemia, run by Thetis Pharmaceuticals LLC at 1 site in United States.
Trial summary
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent, Hypertriglyceridemia
- What is being tested?
- Metformin Eicosapentaenoate and Metformin HCl and Vascepa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent executed prior to protocol screening assessments;
- Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for >1 year. Women who are of childbearing potential must agree to practice adequate contraception one month before the first dose of study medication and up to Day 16 of the study. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods.);
- No history of chronic diseases, except for subjects with well-controlled hypertension or well-controlled hyperlipidemia;
- BMI ≤30kg/m2;
- No significant medical history including diabetes or hypertension complicated by hyperlipidemia (metabolic syndrome);
- Negative urine drug and alcohol tests at Screening; and,
- No metformin or omega-3 products within 2 months.
Who cannot join
- Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator;
- Allergies to fish or shellfish;
- Impaired renal function (calculated eGFR <60 mL/min);
- Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2x upper limits of normal (ULN) or serum bilirubin >1.5 mg/dL;
- Requirement of prescription medication within 14 days of the Screening Visit, with the exception of prescription medications for the prevention of pregnancy, anti hypertensives for hypertension, or statins for hyperlipidemia. Doses of one or two anti-hypertensives and/or a statin must be stable for >1 month;
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- Normal doses of over-the-counter medications, including vitamins are allowed but not within 3 days of Visit 2 (first day of dosing);
- Current or history of abuse of alcohol or illicit drugs within the preceding year to the Screening Visit;
- Participation in a dietary modification or an intensive weight loss program;
- Participation in another clinical trial of an investigational product within 3 months prior to the Screening Visit;
- Smokers (use of tobacco in the past 3 months); or,
- Donation or loss of 400 mL blood or more in the last 8 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: An Open-label, Single and Repeat Single Ascending Dose Escalation Study to Compare the Pharmacokinetics of Metformin Eicosapentaenoate With Metformin Hydrochloride and Icosapent Ethyl Following Oral Administration to Healthy Volunteers
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
- Being tested
- Metformin Eicosapentaenoate, Metformin HCl and Vascepa
- Keywords
- Type 2 diabetes, T2DM, hypertriglyceridemia, severe hypertriglyceridemia, dyslipidemia, triglycerides, lipids, omega-3 fatty acids, EPA, ethyl-EPA, Metformin, Glucophage, Lovaza, Vascepa, Epanova, Astra Zeneca, Amarin, GSK
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin EicosapentaenoateDrug
Metformin HCl and VascepaDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Low Dose | Active comparator | Metformin Eicosapentaenoate 1500 mg or Metformin HCl 500 mg and Vascepa 1000 mg Receives: Drug: Metformin Eicosapentaenoate; Drug: Metformin HCl and Vascepa |
| Cohort B - High Dose | Active comparator | Metformin Eicosapentaenoate 3000 mg or Metformin HCl 1000 mg and Vascepa 2000 mg Receives: Drug: Metformin Eicosapentaenoate; Drug: Metformin HCl and Vascepa |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa
Measured: PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thetis Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113163
- Sponsor's protocol ID
- TP-101-CS01
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2014
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single and Repeat Single Ascending Dose Escalation Study to Compare the Pharmacokinetics of Metformin Eicosapentaenoate With Metformin Hydrochloride and Icosapent Ethyl Following Oral Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02113163
- Acronym / sponsor ID
- TP-101-CS01
- Keywords
- Type 2 diabetes, T2DM, hypertriglyceridemia, severe hypertriglyceridemia, dyslipidemia, triglycerides, lipids, omega-3 fatty acids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Thetis Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Apr 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 primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Low Dose | Active comparator | Drug: Metformin Eicosapentaenoate, Drug: Metformin HCl and VascepaMetformin Eicosapentaenoate 1500 mg or Metformin HCl 500 mg and Vascepa 1000 mg |
| Cohort B - High Dose | Active comparator | Drug: Metformin Eicosapentaenoate, Drug: Metformin HCl and VascepaMetformin Eicosapentaenoate 3000 mg or Metformin HCl 1000 mg and Vascepa 2000 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent executed prior to protocol screening assessments;
- Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for >1 year. Women who are of childbearing potential must agree to practice adequate contraception one month before the first dose of study medication and up to Day 16 of the study. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods.);
- No history of chronic diseases, except for subjects with well-controlled hypertension or well-controlled hyperlipidemia;
- BMI ≤30kg/m2;
- No significant medical history including diabetes or hypertension complicated by hyperlipidemia (metabolic syndrome);
Key exclusion criteria (12 listed)
- Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator;
- Allergies to fish or shellfish;
- Impaired renal function (calculated eGFR <60 mL/min);
- Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2x upper limits of normal (ULN) or serum bilirubin >1.5 mg/dL;
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 |
|---|---|---|
| Metformin Eicosapentaenoate | Drug | Cohort A - Low Dose, Cohort B - High Dose |
| Metformin HCl and Vascepa | Drug | Cohort A - Low Dose, Cohort B - High Dose |
Primary outcome
AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa
Time frame: PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration
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 2 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metformin Eicosapentaenoate and Metformin HCl and Vascepa in people with Diabetes Mellitus, Non-Insulin-Dependent and Hypertriglyceridemia, run by Thetis Pharmaceuticals LLC at 1 site in United States.
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 12 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 2 May 2022. 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 States. 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?
AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa (time frame: PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration). 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 2 May 2022.