Diabetes Mellitus, Type 2Phase 1NCT01780051
A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components
A Phase 1 study testing Repaglinide/Metformin combination, Repaglinide, Metformin in people with Diabetes Mellitus, Type 2, run by Dalim BioTech Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and… Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Repaglinide/Metformin combination, Repaglinide, Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Apr 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers ages between 20 and 55 years at screening
- Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight over 45kg
- Signed informed consent with the date of signature
- With ability to comply with all the scheduled visits, treatment plans; laboratory tests and other processes.
Who cannot join
- Positive of blood, kidney, endocrine, lung, gastro-intestinal, cardiovascular, hepatic, psychiatric, nervous, allergy; or with past and present disease history or symptoms that are clinically significant.
- Any conditions that are likely to affect drug absorption. ex) gastrectomy
- Positive on urine drug tests
- History of drinking alcohol more than 12 ounces(360mL) of beer, 1.5 ounces(45mL) of liquor; or 21 drinks/week(1drink = 5 ounces(150mL) of wine ) 6months prior to screening
- Participation in any other clinical studies within 2months prior to scheduled study drug administration
- With Blood pressure of ≥ 160 mmHg(Systolic blood pressure) or ≥ 90 mmHg(Diastolic blood pressure) in sitting position at screening time.
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- History of any serious substance or alcohol abuse within one year prior to screening
- Use of any drugs known to significantly induce or inhibit drug metabolizing enzyme within 30days prior to scheduled study drug administration
- Cigarette smoking of over 20 sticks per day.
- Use of any prescription drugs or any over the counter drugs within 10days or quintuple half life(whichever is longer) prior to scheduled study drug administration
- Donation of whole blood within 2months or any blood products within 1month, prior to scheduled study drug administration
- Disability to comply with the guidelines written on the protocol
- Severe acute/chronic medical, physical disorder or laboratory test abnormality that are likely to alter the study result and increase the risk by participating in the study and study drug administration
- Hypersensitivity to chief component or excipient of Repaglinide
- History of hypersensitivity to Metformin or Biguanide class of drugs
- With renal failure or renal inadequacy caused by cardiovascular shock, acute myocardial infarction and sepsis
- With Congestive heart failure and undergoing drug treatment.
- Patients undergoing radioactive iodine uptake tests, such as intravenous urography, intravenous cholangiography, angiography, computed tomography using radioactive iodine
- Patients with type 1 diabetes, acute or chronic metabolic acidosis including diabetic ketoacidosis associated with or without coma
- With serious infection or trauma
- Malnutrition, starvation; weakness; pituitary insufficiency or adrenal insufficiency
- Patients with hepatic failure, pulmonary infarction, serious pulmonary dysfunction, or other conditions associated with hypoxemia, alcohol abuser, or dehydration, diarrhea; vomiting and gastro-intestinal disease
- Proven to be unsuitable to participate in this clinical study by an investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chounbuk National University Hospital
Jeonju, Jeollabuk-do
About this study
Official title: An Open-label, Randomized, Single-dose, 2-way Crossover Trial to Compare the Pharmacokinetics of Repaglinide2mg and MetforminHCl 500mg Complex to Combination Preparation of Repaglinide 2mg and MetforminHCl 500mg in Healthy Male Volunteers.
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.
Read the detailed description
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.
- All the subjects should be admitted one day prior to scheduled study date until 4pm to Chonbuk National University Hospital Clinical Trial Center and they will be served with the same dinner. After dinner, they should keep fast, they are just allowed to drink water until 8am of the study date.
- According to the randomly designated order, all subjects will be administrated with the study or reference products with 240mL of water at 9am(±2hours) on the first date of the study. The study or the reference products should be swallowed completely, and not to be chewed before swallowing.
- Study product : Repanorm M 2/500mg (Dalim BioTech Co., Ltd.)
- Reference products : Metformin HCl 500mg tablet, Repaglinide 2mg tablet
- Subjects have to fast for 4 hours post administration of the study or reference drugs(water intake is not allowed for 1 hour before and after the administration), and should follow standardized lunch after four hours and dinner 9 hours later from the time of administration
- Assessment and laboratory test will be performed in accordance with schedule written on the protocol
- After having 7 days of withdrawal period, the 2nd study period will be done at 9am(±2hours). In contrast of the 1st period, Sequence B which received the study product in 1st period will take the reference drugs for the 2nd period, while the group Sequence A which received reference drugs will take the study drug. The steps of administration of drugs and process of tests are the same with the 1st period
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Repaglinide/Metformin combination, Repaglinide, Metformin
- Keywords
- Diabetes Mellitus, Type 2, Pharmacokinetics
- 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.
Repaglinide/Metformin combination, Repaglinide, MetforminDrug
Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1.
Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2.
Repaglinide/Metformin combination, Repaglinide, MetforminDrug
Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1.
Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: Repaglinide/Metformin combination, Repaglinide, Metformin |
| Sequence B | Experimental | Not described Receives: Drug: Repaglinide/Metformin combination, Repaglinide, Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt and Cmax of repaglinide and metformin
Measured: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.
Secondary outcomes (1)
AUC∞, Tmax, t1/2, CL/F and Vd/F of repaglinide and metformin
Measured: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionApr 2013
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalim BioTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, doctor, Principal investigator, Chounbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780051
- Sponsor's protocol ID
- RM0818-01
- Status last verified
- May 2013
- First submitted
- 29 Jan 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-way Crossover Trial to Compare the Pharmacokinetics of Repaglinide2mg and MetforminHCl 500mg Complex to Combination Preparation of Repaglinide 2mg and MetforminHCl 500mg in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01780051
- Acronym / sponsor ID
- RM0818-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dalim BioTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Jan 2013 (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.
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.
Detailed description
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.
- All the subjects should be admitted one day prior to scheduled study date until 4pm to Chonbuk National University Hospital Clinical Trial Center and they will be served with the same dinner. After dinner, they should keep fast, they are just allowed to drink water until 8am of the study date.
- According to the randomly designated order, all subjects will be administrated with the study or reference products with 240mL of water at 9am(±2hours) on the first date of the study. The study or the reference products should be swallowed completely, and not to be chewed before swallowing.
- Study product : Repanorm M 2/500mg (Dalim BioTech Co., Ltd.)
- Reference products : Metformin HCl 500mg tablet, Repaglinide 2mg tablet
- Subjects have to fast for 4 hours post administration of the study or reference drugs(water intake is not allowed for 1 hour before and after the administration), and should follow standardized lunch after four hours and dinner 9 hours later from the time of administration
- Assessment and laboratory test will be performed in accordance with schedule written on the protocol
- After having 7 days of withdrawal period, the 2nd study period will be done at 9am(±2hours). In contrast of the 1st period, Sequence B which received the study product in 1st period will take the reference drugs for the 2nd period, while the group Sequence A which received reference drugs will take the study drug. The steps of administration of drugs and process of tests are the same with the 1st period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Repaglinide/Metformin combination, Repaglinide, Metformin |
| Sequence B | Experimental | Drug: Repaglinide/Metformin combination, Repaglinide, Metformin |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers ages between 20 and 55 years at screening
- Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight over 45kg
- Signed informed consent with the date of signature
- With ability to comply with all the scheduled visits, treatment plans; laboratory tests and other processes.
Key exclusion criteria (23 listed)
- Positive of blood, kidney, endocrine, lung, gastro-intestinal, cardiovascular, hepatic, psychiatric, nervous, allergy; or with past and present disease history or symptoms that are clinically significant.
- Any conditions that are likely to affect drug absorption. ex) gastrectomy
- Positive on urine drug tests
- History of drinking alcohol more than 12 ounces(360mL) of beer, 1.5 ounces(45mL) of liquor; or 21 drinks/week(1drink = 5 ounces(150mL) of wine ) 6months prior to screening
- Participation in any other clinical studies within 2months prior to scheduled study drug administration
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 |
|---|---|---|
| Repaglinide/Metformin combination, Repaglinide, MetforminCo-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1. Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2. | Drug | Sequence A |
| Repaglinide/Metformin combination, Repaglinide, MetforminAdministration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1. Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2. | Drug | Sequence B |
Primary outcome
AUCt and Cmax of repaglinide and metformin
Time frame: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.
1 secondary outcome
AUC∞, Tmax, t1/2, CL/F and Vd/F of repaglinide and metformin
Time frame: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study 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 15 May 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.
Min-Gul Kim, doctor principal investigator
Chounbuk National University Hospital
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 Repaglinide/Metformin combination, Repaglinide, Metformin in people with Diabetes Mellitus, Type 2, run by Dalim BioTech Co., Ltd. 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 4 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 15 May 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 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 and Cmax of repaglinide and metformin (time frame: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study 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 15 May 2013.