DiabetesPhase 1NCT01490658

Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed 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 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and 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: 93 participants
Where: 1 siteUnited States
Study dates: Jun 2006to Aug 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 or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose 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 dose administration
Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing

Trial locations and contacts

1 site in 1 country.

United States1 site

Novo Nordisk Investigational Site
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Randomized, 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 Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and 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
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
metforminDrug
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
repaglinide and metformin combination tabletDrug
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

Study groups in NCT01490658
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	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.

Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration
Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet
Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration
NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet

Secondary outcomes (4)

Repaglinide AUC after NN4440 (1/500) during fed state
Repaglinide Cmax after NN4440 ((1/500) during fed state
Change in physical examinations from screening
Vital signs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Aug 2006

First posted13 Dec 2011 (estimated)
Study startJun 2006
Primary completionAug 2006
Study completionAug 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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490658
Sponsor's protocol ID: NN4440-1753
Status last verified: Feb 2017
First submitted: 8 Dec 2011
Last updated: 10 Feb 2017
Results posted: No
Data monitoring committee: No

Publications

Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004.
PubMed 18666804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Volunteers
ClinicalTrials.gov ID: NCT01490658
Acronym / sponsor ID: NN4440-1753
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 13 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 as co-administered tablets and as a combination tablet.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 3

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	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 or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose 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
repaglinideSingle dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods	Drug	Treatment period 1, Treatment period 2, Treatment period 3
metforminSingle dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods	Drug	Treatment period 1, Treatment period 2, Treatment period 3
repaglinide and metformin combination tabletSingle dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods	Drug	Treatment period 1, Treatment period 2, Treatment period 3

Primary outcome

Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration
Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet
Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration
NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet

4 secondary outcomes

Repaglinide AUC after NN4440 (1/500) during fed state
Repaglinide Cmax after NN4440 ((1/500) during fed state
Change in physical examinations from screening
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 publication: PubMed 18666804Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004.
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?

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 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?

Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet 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 NCT01490658, 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.