Diabetes Mellitus, Type 2Phase 1NCT06141590
A Clinical Study to Evaluate the Safety and the Pharmacokinetics of UI068 in Healthy Adult Volunteers Under Fed Conditions
A Phase 1 study testing administration of UI068 and administration of UIC202205, UIC202206 in people with Diabetes Mellitus, Type 2, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- administration of UI068 and administration of UIC202205, UIC202206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2023to 29 Aug 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects over the ages of 19 at screening
- Subjects whose body weight over 60 kg and having a body mass index (BMI) of over than 18.0 and less than 30.0 kg/m2 at screening (☞ BMI(kg/m2) = Weight(kg)/{Height(m)}2)
- There are no clinically significant congenital diseases/chronic diseases/ pathological symptoms or finding at the screening
- he principal investigator determines to be suitable test subjects as a result of diagnostic tests and electrocardiogram tests etc.
- From the date of first to the last administration of the investigational drug Until 7 weeks , tester or spouse or partner must use a method of contraception recognized in clinical trials.
- The tester who is signed after being explained and understanding about purpose and content of this clinical trial, characteristics of the investigational drug.
Who cannot join
- Clinically significant diseases related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, ENT system, skin system, and ophthalmic system. Those who have or have a history of
- Those with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
- Those who took drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month of the first dose, or took drugs that may interfere with this clinical trial within 10 days of the first dose.
- A person who participated in another clinical trial or bioequivalence test and administered an investigational drug within 6 months of the first administration date
- Those who donated whole blood or component blood within 2 weeks or received a blood transfusion within 4 weeks of the first administration date
- Those who meet the following conditions within 1 month of the first medication date
Show all 24Show fewer
- Alcohol consumption exceeding 21 drinks/week on average for men
- For women, alcohol consumption exceeds an average of 14 drinks/week
- (1 glass = 50 mL of soju or 30 mL of liquor or 250 mL of beer)
- Smoking more than 20 cigarettes per day on average
- Those who fall under the following
- Patients with hypersensitivity to clinical investigational drugs or ingredients contained in clinical investigational drugs
- Persons with a history of hypersensitivity to biguanide drugs
- Patients with the following diseases
- Patients with moderate (stage3b) and severe renal impairment (eGFR<45mL/min/1.73m2), Acute conditions that can affect kidney function, such as diabetes, serious infections, cardiovascular collapse (shock), acute myocardial infarction, and sepsis
- Patients with acute and unstable heart failure
- Patients undergoing tests requiring intravenous administration of radioiodine contrast material (e.g., intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast agent, etc.)
- Patients with acute or chronic metabolic acidosis, including type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- Diabetic precoma
- Patients with severe infections or severe traumatic systemic disorders
- Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal dysfunction
- Patients with acute or chronic diseases that can cause tissue hypoxia such as liver dysfunction, respiratory failure, acute myocardial infarction, and shock, excessive alcohol intake, and gastrointestinal disorders such as dehydration, diarrhea, and vomiting
- Persons judged by the principal investigator to be unsuitable for participation in this clinical trial for reasons other than the above selection/exclusion criteria
- For female volunteers, those who are pregnant, suspected of being pregnant, or lactating
Trial locations and contacts
1 site in 1 country.
About this study
This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- administration of UI068, administration of UIC202205, UIC202206
- 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.
administration of UI068Drug
Test
administration of UIC202205, UIC202206Drug
Reference
| Study group | Role | What they receive |
|---|---|---|
| UI068 | Experimental | Not described Receives: Drug: administration of UI068 |
| UIC202205, UIC202206 | Experimental | Not described Receives: Drug: administration of UIC202205, UIC202206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Evaluation PK for Linagliptin and Metformin after single dose
Measured: 0 to 72hr
Cmax
Evaluation PK for Linagliptin and Metformin after single dose
Measured: 0 to 72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start11 Mar 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141590
- Sponsor's protocol ID
- KUP-UI068-101
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and the Pharmacokinetics of UI068 in Healthy Adult Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06141590
- Acronym / sponsor ID
- KUP-UI068-101
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 21 Nov 2023 (actual)
- 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.
This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI068 | Experimental | Drug: administration of UI068 |
| UIC202205, UIC202206 | Experimental | Drug: administration of UIC202205, UIC202206 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects over the ages of 19 at screening
- Subjects whose body weight over 60 kg and having a body mass index (BMI) of over than 18.0 and less than 30.0 kg/m2 at screening (☞ BMI(kg/m2) = Weight(kg)/{Height(m)}2)
- There are no clinically significant congenital diseases/chronic diseases/ pathological symptoms or finding at the screening
- he principal investigator determines to be suitable test subjects as a result of diagnostic tests and electrocardiogram tests etc.
- From the date of first to the last administration of the investigational drug Until 7 weeks , tester or spouse or partner must use a method of contraception recognized in clinical trials.
Key exclusion criteria (24 listed)
- Clinically significant diseases related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, ENT system, skin system, and ophthalmic system. Those who have or have a history of
- Those with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
- Those who took drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month of the first dose, or took drugs that may interfere with this clinical trial within 10 days of the first dose.
- A person who participated in another clinical trial or bioequivalence test and administered an investigational drug within 6 months of the first administration date
- Those who donated whole blood or component blood within 2 weeks or received a blood transfusion within 4 weeks of the first administration date
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 |
|---|---|---|
| administration of UI068Test | Drug | UI068 |
| administration of UIC202205, UIC202206Reference | Drug | UIC202205, UIC202206 |
Primary outcome
AUCt
Time frame: 0 to 72hr
Evaluation PK for Linagliptin and Metformin after single dose
Cmax
Time frame: 0 to 72hr
Evaluation PK for Linagliptin and Metformin after single dose
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 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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 administration of UI068 and administration of UIC202205, UIC202206 in people with Diabetes Mellitus, Type 2, run by Korea United Pharm. Inc. at 1 site in South Korea.
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 24 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 21 Nov 2023. 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 South Korea. 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?
AUCt (time frame: 0 to 72hr). The study lists 2 primary outcomes in all. 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 21 Nov 2023.