DiabetesPhase 1NCT00959101
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers
A Phase 1 study testing repaglinide and metformin combination tablet, repaglinide and metformin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in China.
Trial summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- What is being tested?
- repaglinide and metformin combination tablet, repaglinide and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Oct 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to sign informed consent before initiating any trial related procedures
- BMI: 19.0-25.0 kg/m2
- Fasting plasma glucose: 3.9-6.1 mmol/L
- Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, and routine laboratory data
Who cannot join
- Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
- Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
- Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial
- Currently a smoker (more than one cigarette per day or equivalent)
- Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
- Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 2 months prior to trial product dose administration
Show all 11Show fewer
- Recent history (within the last 2 years) of drug or alcohol abuse
- Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions
- Subject has taken an investigational drug in another clinical trial within the last 4 weeks.
- Recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Male Volunteers
This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.
The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.
- Being tested
- repaglinide and metformin combination tablet, repaglinide, metformin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repaglinide and metformin combination tabletDrug
Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
repaglinide and metformin combination tabletDrug
Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
repaglinideDrug
Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
metforminDrug
Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: repaglinide and metformin combination tablet |
| B | Experimental | Not described Receives: Drug: repaglinide and metformin combination tablet |
| C | Active comparator | Not described Receives: Drug: repaglinide; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state)
Measured: 24hr profile after single dose of trial drug in each treatment period
Secondary outcomes (1)
Repaglinide AUC(0-24 & 0-∞) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state
Measured: 24hr profile after single dose of trial drug in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959101
- Sponsor's protocol ID
- NN4440-1963
- Status last verified
- Mar 2015
- First submitted
- 13 Aug 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00959101
- Acronym / sponsor ID
- NN4440-1963
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Aug 2009 (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 trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.
The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: repaglinide and metformin combination tablet |
| B | Experimental | Drug: repaglinide and metformin combination tablet |
| C | Active comparator | Drug: repaglinide, Drug: metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to sign informed consent before initiating any trial related procedures
- BMI: 19.0-25.0 kg/m2
- Fasting plasma glucose: 3.9-6.1 mmol/L
- Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, and routine laboratory data
Key exclusion criteria (11 listed)
- Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
- Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
- Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial
- Currently a smoker (more than one cigarette per day or equivalent)
- Use of grapefruit or grapefruit juice within 7 days of trial product dose 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 and metformin combination tabletCombination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast | Drug | A |
| repaglinide and metformin combination tabletCombination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast | Drug | B |
| repaglinideCo-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast | Drug | C |
| metforminConcomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet | Drug | C |
Primary outcome
AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state)
Time frame: 24hr profile after single dose of trial drug in each treatment period
1 secondary outcome
Repaglinide AUC(0-24 & 0-∞) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state
Time frame: 24hr profile after single dose of trial drug in each treatment period
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 24 Mar 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 and metformin combination tablet, repaglinide and metformin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in China.
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 11 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 24 Mar 2015. 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 China. 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?
AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state) (time frame: 24hr profile after single dose of trial drug in each treatment period). 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 24 Mar 2015.