HealthyPhase 1NCT01276327

Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

A Phase 1 study testing Linagliptin + Pioglitazone and Linagliptin/Pioglitazone in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Linagliptin + Pioglitazone and Linagliptin/Pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteGermany
Study dates: Jan 2011to May 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

Healthy male and female subjects

Who cannot join

Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1264.14.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)

Conditions: Healthy
Being tested: Linagliptin + Pioglitazone, Linagliptin/Pioglitazone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Linagliptin + PioglitazoneDrug
Medium doses, oral administration
Linagliptin + PioglitazoneDrug
Medium doses, oral administration
Linagliptin/PioglitazoneDrug
Medium dose oral administration
Linagliptin/PioglitazoneDrug
Medium dose oral administration

Study groups in NCT01276327
Study group	Role	What they receive
1 Linagliptin/Pioglitazone (Test)	Experimental	Fixed-Dose-Combination-Tablet, oral administration with 240 mL water Receives: Drug: Linagliptin/Pioglitazone
2 Linagliptin + Pioglitazone (Ref)	Experimental	Tablets, oral administration with 240 mL water for each treatment Receives: Drug: Linagliptin + Pioglitazone
3 Linagliptin/Pioglitazone (Test)	Experimental	Fixed-Dose-Combination-Tablet, oral administration with 240 mL water Receives: Drug: Linagliptin/Pioglitazone
4 Linagliptin + Pioglitazone (Ref)	Experimental	Tablets, oral administration with 240 mL water for each treatment Receives: Drug: Linagliptin + Pioglitazone

What is being measured

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

AUC0-72 of Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Cmax of Linagliptin
Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
AUC0-tz of Pioglitazone
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Cmax of Pioglitazone
Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

Secondary outcomes (5)

AUC0-tz for Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
AUC0-∞ of Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
AUC0-∞ of Pioglitazone
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Tmax for Linagliptin
Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Tmax for Pioglitazone
Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone
Measured: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

Timeline

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

Jan 2011May 2011

First posted13 Jan 2011 (estimated)
Study startJan 2011
Primary completionMay 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 HealthyStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01276327
Sponsor's protocol ID: 1264.14
Other IDs: 2010-022649-29
Status last verified: Mar 2014
First submitted: 12 Jan 2011
Last updated: 9 Jun 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)
ClinicalTrials.gov ID: NCT01276327
Acronym / sponsor ID: 1264.14
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: May 2011 (actual)
First posted: 13 Jan 2011 (estimated)
Results: Posted 17 Apr 2014

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

Arm	Type	Receives
1 Linagliptin/Pioglitazone (Test)	Experimental	Drug: Linagliptin/PioglitazoneFixed-Dose-Combination-Tablet, oral administration with 240 mL water
2 Linagliptin + Pioglitazone (Ref)	Experimental	Drug: Linagliptin + PioglitazoneTablets, oral administration with 240 mL water for each treatment
3 Linagliptin/Pioglitazone (Test)	Experimental	Drug: Linagliptin/PioglitazoneFixed-Dose-Combination-Tablet, oral administration with 240 mL water
4 Linagliptin + Pioglitazone (Ref)	Experimental	Drug: Linagliptin + PioglitazoneTablets, oral administration with 240 mL water for each treatment

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy male and female subjects

Key exclusion criteria (1 listed)

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
Linagliptin + PioglitazoneMedium doses, oral administration	Drug	2 Linagliptin + Pioglitazone (Ref)
Linagliptin + PioglitazoneMedium doses, oral administration	Drug	4 Linagliptin + Pioglitazone (Ref)
Linagliptin/PioglitazoneMedium dose oral administration	Drug	1 Linagliptin/Pioglitazone (Test)
Linagliptin/PioglitazoneMedium dose oral administration	Drug	3 Linagliptin/Pioglitazone (Test)

Primary outcome

AUC0-72 of Linagliptin
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours
Cmax of Linagliptin
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.
AUC0-tz of Pioglitazone
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Cmax of Pioglitazone
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.

5 secondary outcomes

AUC0-tz for Linagliptin
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
AUC0-∞ of Linagliptin
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
AUC0-∞ of Pioglitazone
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Tmax for Linagliptin
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Tmax for Pioglitazone
Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

Results and safety

Results posted to the registry on 17 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence TRTR	32	30
Sequence RTRT	32	29

Primary outcome: AUC0-72 of Linagliptin

Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours). Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	FDC L5P30 (Test) n = 62	L5+P30 (Ref) n = 63
Value	278 (20.6)	279 (20.6)

FDC L5P30 (Test) vs L5+P30 (Ref): Adjusted gMean Ratio (Test/Ref) (%): 99.92 (90% CI 97.11 to 102.81), Unscaled average Bioequivalence

Population analysed: PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.

Primary outcome: Cmax of Linagliptin

Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours). Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	FDC L5P30 (Test) n = 62	L5+P30 (Ref) n = 63
Value	8.65 (33.3)	9.09 (31.2)

FDC L5P30 (Test) vs L5+P30 (Ref): Adjusted gMean Ratio (Test/Ref) (%): 94.17 (90% CI 89.08 to 99.55), Unscaled average Bioequivalence

Primary outcome: AUC0-tz of Pioglitazone

Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours). Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	FDC L5P30 (Test) n = 62	L5+P30 (Ref) n = 63
Value	6370 (49.3)	8100 (41.2)

FDC L5P30 (Test) vs L5+P30 (Ref): Adjusted gMean Ratio (Test/Ref) (%): 79.99 (90% CI 74.65 to 85.72), Scaled average bioequivalence (SABE)

Primary outcome: Cmax of Pioglitazone

Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	FDC L5P30 (Test) n = 62	L5+P30 (Ref) n = 63
Value	806 (58.5)	843 (42.7)

FDC L5P30 (Test) vs L5+P30 (Ref): Adjusted gMean Ratio (Test/Ref) (%): 97.31 (90% CI 88.90 to 106.51), Scaled average bioequivalence (SABE)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 days treatment period (one day for every single dose), 35 days washout between drug administrations. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FDC L5P30 (Test)	0 of 62 (0%)	13 of 62 (21%)	Not reported
L5+P30 (Ref)	1 of 63 (1.6%)	7 of 63 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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 Linagliptin + Pioglitazone and Linagliptin/Pioglitazone in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 9 Jun 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 Germany. 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 17 Apr 2014). 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?

AUC0-72 of Linagliptin (time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)). 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 NCT01276327.

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 9 Jun 2014.