DiabetesPhase 1NCT01489644
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers
A Phase 1 study testing repaglinide, metformin and repaglinide and metformin combination tablet in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide, metformin and repaglinide and metformin combination tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Jul 2006
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
- BMI (Body Mass Index) between 19-29 kg/m^2, both inclusive
- Fasting plasma glucose from 70-115 mg/dl
- Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), 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
- Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
- Positive results on the drug abuse/alcohol screen
- Any regular use of prescription or nonprescription drugs, including mega-vitamin, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product administration) and for the duration of the study
- Subject is currently a smoker (more than one cigarette per day or equivalent)
- Use of grapefruit or grapefruit juice within 7 days of trial product administration
- Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novo Nordisk Investigational Site
Miami, Florida, 33169
Novo Nordisk Investigational Site
Tacoma, Washington, 98418
About this study
Official title: A Randomized, Single-Blind, Four-Period Crossover Study Examining the Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet Dosing (NN4440) in Fasting and Fed Healthy Volunteers
This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, metformin, repaglinide and metformin combination tablet
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repaglinideDrug
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
metforminDrug
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
repaglinide and metformin combination tabletDrug
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | Not described Receives: Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet |
| Treatment period 2 | Experimental | Not described Receives: Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet |
| Treatment period 3 | Experimental | Not described Receives: Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet |
| Treatment period 4 | Active comparator | Not described Receives: Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration
Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration
Secondary outcomes (4)
Repaglinide and metformin tmax (time to maximum) following individual administration fasting state
Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state
Physical examinations
Vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJun 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 62 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
- NCT01489644
- Sponsor's protocol ID
- NN4440-1779
- Status last verified
- Feb 2017
- First submitted
- 8 Dec 2011
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Reilley S, Chang C-T, Lyness W. Single-Dose Pharmacokinetics of a Repaglinide/Metformin Fixed-Dose Combination Tablet in Fasted and Fed Conditions. Diabetes 2008; 57 (Suppl 1): 2449 in 01-D
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Four-Period Crossover Study Examining the Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet Dosing (NN4440) in Fasting and Fed Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01489644
- Acronym / sponsor ID
- NN4440-1779
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Dec 2011 (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 the United States of America (USA). The aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: repaglinide, Drug: metformin, Drug: repaglinide and metformin combination tablet |
| Treatment period 2 | Experimental | Drug: repaglinide, Drug: metformin, Drug: repaglinide and metformin combination tablet |
| Treatment period 3 | Experimental | Drug: repaglinide, Drug: metformin, Drug: repaglinide and metformin combination tablet |
| Treatment period 4 | Active comparator | Drug: repaglinide, Drug: metformin, Drug: repaglinide and metformin combination tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
- BMI (Body Mass Index) between 19-29 kg/m^2, both inclusive
- Fasting plasma glucose from 70-115 mg/dl
- Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
Key exclusion criteria (8 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
- Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
- Positive results on the drug abuse/alcohol screen
- Any regular use of prescription or nonprescription drugs, including mega-vitamin, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product administration) and for the duration of the study
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 |
|---|---|---|
| repaglinideSubjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order | Drug | Treatment period 1, Treatment period 2, Treatment period 3, Treatment period 4 |
| metforminSubjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order | Drug | Treatment period 1, Treatment period 2, Treatment period 3, Treatment period 4 |
| repaglinide and metformin combination tabletSubjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order | Drug | Treatment period 1, Treatment period 2, Treatment period 3, Treatment period 4 |
Primary outcome
Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration
Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration
4 secondary outcomes
Repaglinide and metformin tmax (time to maximum) following individual administration fasting state
Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state
Physical examinations
Vital signs
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 10 Feb 2017.
- Results publicationReilley S, Chang C-T, Lyness W. Single-Dose Pharmacokinetics of a Repaglinide/Metformin Fixed-Dose Combination Tablet in Fasted and Fed Conditions. Diabetes 2008; 57 (Suppl 1): 2449 in 01-D
- 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
2 sites 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 and repaglinide and metformin combination tablet in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites 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 4 inclusion and 8 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489644, which also lists 1 linked publication.
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 10 Feb 2017.