Diabetes Mellitus, Type 2Phase 1NCT01383356

Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

A Phase 1 study testing Metformin Single Tablet, Linagliptin/Metformin Combo and Linagliptin Single Tablet in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Canada.

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

The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Metformin Single Tablet, Linagliptin/Metformin Combo and Linagliptin Single Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteCanada
Study dates: Jun 2011to Dec 2011
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

1. Healthy male and female subjects.

Who cannot join

1. Any relevant deviation from healthy conditions.

Trial locations and contacts

1 site in 1 country.

Canada1 site

1288.19.1 Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions

Conditions: Diabetes Mellitus, Type 2
Being tested: Metformin Single Tablet, Linagliptin/Metformin Combo, Linagliptin Single Tablet
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 Single TabletDrug
Metformin medium doseTablet
Linagliptin/Metformin ComboDrug
Fixed dose combination
Linagliptin Single TabletDrug
Linagliptin Single medium dose Tablet

Study groups in NCT01383356
Study group	Role	What they receive
Linagliptin/Metformin medium dosecombo	Experimental	patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily Receives: Drug: Linagliptin/Metformin Combo
Linagliptin plus Metformin medium dose	Active comparator	patient to receive two individual tablets: Linagliptin and Metformin (medium dose) Receives: Drug: Metformin Single Tablet; Drug: Linagliptin Single Tablet

What is being measured

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

Maximum Plasma Concentration (Cmax)
Maximum measured concentration of metformin in plasma, per period.
Measured: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Area Under the Curve 0 to Last Measurable Value (AUC0-t)
AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.
Measured: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period

Secondary outcomes (1)

Area Under the Curve 0 to Inf (AUC0-inf)
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
Measured: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose 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.

Jun 2011Dec 2011

First posted28 Jun 2011 (estimated)
Study startJun 2011
Primary completionDec 2011
Study completionDec 2011

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 Boehringer IngelheimThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01383356
Sponsor's protocol ID: 1288.19
Status last verified: Feb 2014
First submitted: 27 Jun 2011
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

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 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions
ClinicalTrials.gov ID: NCT01383356
Acronym / sponsor ID: 1288.19
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 24 Jan 2013

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Linagliptin/Metformin medium dosecombo	Experimental	Drug: Linagliptin/Metformin Combopatient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
Linagliptin plus Metformin medium dose	Active comparator	Drug: Metformin Single Tablet, Drug: Linagliptin Single Tabletpatient to receive two individual tablets: Linagliptin and Metformin (medium dose)

Who may qualify

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

Key inclusion criteria (1 listed)

1. Healthy male and female subjects.

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions.

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 Single TabletMetformin medium doseTablet	Drug	Linagliptin plus Metformin medium dose
Linagliptin/Metformin ComboFixed dose combination	Drug	Linagliptin/Metformin medium dosecombo
Linagliptin Single TabletLinagliptin Single medium dose Tablet	Drug	Linagliptin plus Metformin medium dose

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Maximum measured concentration of metformin in plasma, per period.
Area Under the Curve 0 to Last Measurable Value (AUC0-t)
Time frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.

1 secondary outcome

Area Under the Curve 0 to Inf (AUC0-inf)
Time frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period

Results and safety

Results posted to the registry on 24 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg	29	21
Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg	29	23

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period. Mean (Standard Deviation). Unit: ng/ml

Measure	Lina/Met 2.5mg/500mg n = 44	Lina 2.5mg Plus Met 500mg n = 44
Value	901.82 (262.45)	770.52 (189.44)

Lina/Met 2.5mg/500mg vs Lina 2.5mg Plus Met 500mg: Geometric mean ratio (GMR) in percent: 118 (90% CI 111 to 125)
Lina/Met 2.5mg/500mg vs Lina 2.5mg Plus Met 500mg: GMR, potency corrected (percent): 122 (90% CI 114 to 130)

Population analysed: All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.

Primary outcome: Area Under the Curve 0 to Last Measurable Value (AUC0-t)

Measure	Lina/Met 2.5mg/500mg n = 44	Lina 2.5mg Plus Met 500mg n = 44
Value	7079.65 (1688.14)	6808.27 (1708.20)

Lina/Met 2.5mg/500mg vs Lina 2.5mg Plus Met 500mg: Geometric mean ratio (percent): 105 (90% CI 101 to 108)
Lina/Met 2.5mg/500mg vs Lina 2.5mg Plus Met 500mg: GMR, potency corrected (percent): 108 (90% CI 105 to 112)

Population analysed: All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Period 1 (36 hours)+ Washout (35 days) +Period 2 (36 hours). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lina/Met 2.5mg/500mg	0 of 52 (0%)	17 of 52 (32.7%)	Not reported
Lina 2.5mg Plus Met 500mg	0 of 50 (0%)	21 of 50 (42%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Single Tablet, Linagliptin/Metformin Combo and Linagliptin Single Tablet in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Canada.

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 1 inclusion and 1 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 28 Mar 2014. 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 Canada. 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 24 Jan 2013). 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?

Maximum Plasma Concentration (Cmax) (time frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period). 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 NCT01383356.

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 28 Mar 2014.