Type 2 Diabetes MellitusPhase 1NCT01068730

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects

A Phase 1 study testing metformin (Diabex) and metformin (Glucophage™) in people with Type 2 Diabetes Mellitus, run by AstraZeneca 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

To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: metformin (Diabex) and metformin (Glucophage™)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Apr 2010
Phase: Phase 1
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women ages 18 to 55 inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²

Who cannot join

Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
History of allergy or intolerance to metformin or other similar acting agents
Prior exposure to metformin within 3 months of study drug administration
Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development, LP
Austin, Texas, 78744

Other trials in United States

About this study

Official title: Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State

Conditions: Type 2 Diabetes Mellitus
Being tested: metformin (Diabex), metformin (Glucophage™)
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.

metformin (Diabex)Drug
Also called Diabex
Tablets, Oral, 500 mg, Once daily, single dose
metformin (Glucophage™)Drug
Also called Glucophage™
Tablets, Oral, 500 mg, Once Daily, single dose
metformin (Glucophage™)Drug
Also called Glucophage™
Tablets, Oral, 1000 mg, Once daily, single dose
metformin (Diabex)Drug
Also called Diabex
Tablets, Oral, 1000 mg, Once daily, single dose

Study groups in NCT01068730
Study group	Role	What they receive
Treatment A	Other	500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition Receives: Drug: metformin (Diabex)
Treatment B	Other	500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition Receives: Drug: metformin (Glucophage™)
Treatment C	Other	1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition Receives: Drug: metformin (Diabex)
Treatment D	Other	1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition Receives: Drug: metformin (Glucophage™)

What is being measured

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

Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Measured: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Measured: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing

Secondary outcomes (7)

Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).
Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE
Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
Measured: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Abnormal Physical Findings
Physical findings that were considered abnormal by the investigator.
Measured: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Abnormal Vital Sign Findings Reported as an AE
per investigator
Measured: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology
Clinically significant was determined by the investigator.
Measured: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry
Clinically significant was determined by the investigator.
Measured: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis
Clinically significant was determined by the investigator.
Measured: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).

Timeline

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

Feb 2010Apr 2010

First posted15 Feb 2010 (estimated)
Study startFeb 2010
Primary completionApr 2010
Study completionApr 2010

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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068730
Sponsor's protocol ID: CV181-120
Status last verified: Mar 2015
First submitted: 12 Feb 2010
Last updated: 8 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State
ClinicalTrials.gov ID: NCT01068730
Acronym / sponsor ID: CV181-120
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A	Other	Drug: metformin (Diabex)500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition
Treatment B	Other	Drug: metformin (Glucophage™)500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition
Treatment C	Other	Drug: metformin (Diabex)1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition
Treatment D	Other	Drug: metformin (Glucophage™)1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Men and women ages 18 to 55 inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²

Key exclusion criteria (6 listed)

Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
History of allergy or intolerance to metformin or other similar acting agents
Prior exposure to metformin within 3 months of 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
metformin (Diabex)Also: DiabexTablets, Oral, 500 mg, Once daily, single dose	Drug	Treatment A
metformin (Glucophage™)Also: Glucophage™Tablets, Oral, 500 mg, Once Daily, single dose	Drug	Treatment B
metformin (Glucophage™)Also: Glucophage™Tablets, Oral, 1000 mg, Once daily, single dose	Drug	Treatment D
metformin (Diabex)Also: DiabexTablets, Oral, 1000 mg, Once daily, single dose	Drug	Treatment C

Primary outcome

Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
Time frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
Time frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.

7 secondary outcomes

Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
Time frame: AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).
Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Abnormal Physical Findings
Time frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Abnormal Vital Sign Findings Reported as an AE
Time frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).

Results and safety

Results posted to the registry on 29 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ADBC	7	7
Treatment Sequence BACD	7	7
Treatment Sequence CBDA	7	7
Treatment Sequence DCAB	7	7

Primary outcome: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])

Time frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Treatment A - 500 mg Diabex n = 28	Treatment B - 500 mg Glucophage n = 27	Treatment C - 1000 mg Diabex n = 27	Treatment D - 1000 mg Glucophage n = 25
Value	7062.76 (26.91)	7187.14 (25.95)	11577.85 (27.36)	11424.73 (29.06)

Treatment A - 500 mg Diabex vs Treatment B - 500 mg Glucophage: Ratio (%) of Geometric LS Means: 102.58 (95% CI 99.07 to 106.23)
Treatment C - 1000 mg Diabex vs Treatment D - 1000 mg Glucophage: Ratio (%) of Geometric LS Means: 99.67 (95% CI 96.16 to 103.31)
Treatment A - 500 mg Diabex: Geometric Least Squares Mean (ng*hr/mL): 7062.8

Population analysed: All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.

Primary outcome: Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)

Time frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A - 500 mg Diabex n = 28	Treatment B - 500 mg Glucophage n = 27	Treatment C - 1000 mg Diabex n = 27	Treatment D - 1000 mg Glucophage n = 26
Value	1013.57 (25.67)	1019.59 (25.26)	1635.30 (27.67)	1593.20 (26.87)

Treatment A - 500 mg Diabex vs Treatment B - 500 mg Glucophage: Ratio (%) of Geometric LS Means: 101.12 (95% CI 96.36 to 106.11)
Treatment C - 1000 mg Diabex vs Treatment D - 1000 mg Glucophage: Ratio (%) of Geometric LS Means: 98.65 (95% CI 93.94 to 103.59)
Treatment A - 500 mg Diabex: Geometric Least Squares Mean (ng/mL): 1013.6

Population analysed: All treated participants with evaluable PK analyses.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment C - 1000 mg Diabex	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
Treatment D - 1000 mg Glucophage	0 of 27 (0%)	6 of 27 (22.2%)	Not reported
Treatment A - 500 mg Diabex	0 of 28 (0%)	6 of 28 (21.4%)	Not reported
Treatment B - 500 mg Glucophage	0 of 27 (0%)	2 of 27 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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 metformin (Diabex) and metformin (Glucophage™) in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site 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 3 inclusion and 6 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 8 May 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 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?

Yes. Results are posted in the registry (first posted 29 Mar 2012). 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?

Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) (time frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing). The study lists 2 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 NCT01068730.

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 8 May 2015.