Diabetes Mellitus, Type 2Phase 4NCT01842620

OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

A Phase 4 study testing Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline.

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

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: 13 Mar 2013to 4 May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
Single QTc < 450 msec.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 21 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
A female subject is eligible to participate if she is of child-bearing potential and is abstinent or agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 days post-last dose.
Body weight > 50 kg and BMI within the range 19 - 27 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 14 drinks for males or > 7 drinks for females. One drink is equivalent to 12 g of alcohol: 360 mL of beer, 150 mL of wine or 45 mL of 40% abv distilled spirits.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Show all 20Show fewer

Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or prior to dosing, or greater than 140/90 mmHg at screening.
Subjects whose pulse is lower than 50 beats per minute or higher than 99 beats per minute at screening or prior to dosing.
Subjects whose ECG PR interval is > 220 msec at screening or prior to dosing.
Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
History of sensitivity to heparin or heparin-induced thrombocytopenia.

About this study

Official title: Oral Bioavailability Study Comparing OXEMET™ 1000 mg Coated Tablets Containing Metformin Hydrochloride With 1000 mg of the Reference Product (GLAFORNIL™) Administered as Two 500 mg Tablets, Through a Randomized, Single-dose, Open Label, Balanced, 2-way Crossover Study in Healthy Volunteers Under Fasting Conditions.OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period 1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two 500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

Conditions: Diabetes Mellitus, Type 2
Being tested: Metformin
Keywords: Metformin, Bioequivalence
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.

MetforminDrug
Oral antidiabetic agent

Study groups in NCT01842620
Study group	Role	What they receive
OXEMET 1000 mg coated tablets	Experimental	Generic undergoing bioequivalence study against reference Receives: Drug: Metformin
GLAFORNIL 500 mg tablets	Active comparator	Reference drug for bioequivalence study Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)
Area under plasma concentration-time curve of metformin was quantifiable from time 0 to 36 h. The parameter was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.
Measured: From 0 to 36 hours (h)
Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period
Area under plasma concentration-time curve of metformin from time 0 to inf was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.
Measured: From 0 to 36 h
Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h
Cmax is maximum plasma concentration of metformin. Plasma concentration-time curve of metformin from time 0 to 36 h was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise data has been presented; however, the statistical analysis has been presented for overall period.
Measured: From 0 to 36 h

Secondary outcomes (3)

The Elimination Constant (Kel) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h
The elimination constant (kel) of Metformin was analyzed for each participant, both for Test and Reference products. The calculations were based on the actual sampling times recorded during the study.
Measured: From 0 to 36 h
Terminal Plasma Half-life (t1/2) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h
Terminal phase half-life is the time required for the study drug to reduce to 50% of its concentration. t1/2 of Metformin was determined for each participant, both for Test and Reference products.
Measured: From 0 to 36 h
Time to Reach Maximum Plasma Concentration (Tmax) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) Over Period
Time to reach maximum plasma concentration is the time at which Cmax of metformin was obtained for test and reference products.
Measured: From 0 to 36 h

Timeline

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

13 Mar 20134 May 2013

First posted29 Apr 2013 (estimated)
Study start13 Mar 2013
Primary completion4 May 2013
Study completion4 May 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01842620
Sponsor's protocol ID: 117219
Status last verified: Jul 2017
First submitted: 25 Apr 2013
Last updated: 22 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Bioavailability Study Comparing OXEMET™ 1000 mg Coated Tablets Containing Metformin Hydrochloride With 1000 mg of the Reference Product (GLAFORNIL™) Administered as Two 500 mg Tablets, Through a Randomized, Single-dose, Open Label, Balanced, 2-way Crossover Study in Healthy Volunteers Under Fasting Conditions.OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
ClinicalTrials.gov ID: NCT01842620
Acronym / sponsor ID: 117219
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin, Bioequivalence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Mar 2013 (actual)
Primary completion: 4 May 2013 (actual)
Study completion: 4 May 2013 (actual)
First posted: 29 Apr 2013 (estimated)
Results: Posted 22 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OXEMET 1000 mg coated tablets	Experimental	Drug: MetforminGeneric undergoing bioequivalence study against reference
GLAFORNIL 500 mg tablets	Active comparator	Drug: MetforminReference drug for bioequivalence study

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
Single QTc < 450 msec.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 21 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.

Key exclusion criteria (20 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 14 drinks for males or > 7 drinks for females. One drink is equivalent to 12 g of alcohol: 360 mL of beer, 150 mL of wine or 45 mL of 40% abv distilled spirits.

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
MetforminOral antidiabetic agent	Drug	GLAFORNIL 500 mg tablets, OXEMET 1000 mg coated tablets

Primary outcome

Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)
Time frame: From 0 to 36 hours (h)
Area under plasma concentration-time curve of metformin was quantifiable from time 0 to 36 h. The parameter was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.
Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period
Time frame: From 0 to 36 h
Area under plasma concentration-time curve of metformin from time 0 to inf was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.
Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h
Time frame: From 0 to 36 h
Cmax is maximum plasma concentration of metformin. Plasma concentration-time curve of metformin from time 0 to 36 h was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise data has been presented; however, the statistical analysis has been presented for overall period.

3 secondary outcomes

The Elimination Constant (Kel) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h
Time frame: From 0 to 36 h
Terminal Plasma Half-life (t1/2) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h
Time frame: From 0 to 36 h
Time to Reach Maximum Plasma Concentration (Tmax) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) Over Period
Time frame: From 0 to 36 h

Results and safety

Results posted to the registry on 22 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OXEMET Then GLAFORNIL	13	12
GLAFORNIL Then OXEMET	12	12

Primary outcome: Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)

Time frame: From 0 to 36 hours (h). Geometric mean (Geometric Coefficient of Variation). Unit: nanogram* h/millilitre (ng*h/mL)

Measure	OXEMET 1000 mg Once Daily n = 24	GLAFORNIL 1000 mg BID n = 24
Period 1	12348 (27)	12727 (22)
Period 2	13470 (26)	13069 (24)

OXEMET 1000 mg Once Daily vs GLAFORNIL 1000 mg BID: (Ratio of AUC0-36)*100: 100 (90% CI 92.62 to 107.98)

Population analysed: PK parameters \[PKP\] population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results.

Primary outcome: Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period

Time frame: From 0 to 36 h. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	OXEMET 1000 mg Once Daily n = 24	GLAFORNIL 1000 mg BID n = 24
Period 1	12636 (26)	13171 (21)
Period 2	13902 (25)	13604 (22)

OXEMET 1000 mg Once Daily vs GLAFORNIL 1000 mg BID: (Ratio of AUC0-inf)*100: 99.02 (90% CI 92.26 to 106.27)

Population analysed: PKP population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results

Primary outcome: Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h

Time frame: From 0 to 36 h. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	OXEMET 1000 mg Once Daily n = 24	GLAFORNIL 1000 mg BID n = 24
Period 1	2031.5 (32)	2097.8 (23)
Period 2	2124.5 (28)	2127.4 (25)

OXEMET 1000 mg Once Daily vs GLAFORNIL 1000 mg BID: (Ratio of Cmax)*100: 98.34 (90% CI 88.54 to 109.22)

Population analysed: PKP population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately up to 16 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OXEMET 1000 mg Once Daily	0 of 25 (0%)	1 of 25 (4%)	0 of 25
GLAFORNIL 1000 mg BID	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline.

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 8 inclusion and 20 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h) (time frame: From 0 to 36 hours (h)). The study lists 3 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 NCT01842620.

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 22 Dec 2017.