Diabetes Mellitus, Type 2Phase 1NCT00935220

Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients

A Phase 1 study testing linagliptin QD (once daily) for 7 days in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 6 sites 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

The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: linagliptin QD (once daily) for 7 days
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 6 sitesUnited States
Study dates: Jun 2009to Aug 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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Glycosylated haemoglobin >=7 and <= 10%
Age >=21 and <= 65
Body Mass Index >=18.5 and <=38 kg/m2
African American origin
Signed and dated informed consent prior to admission to the study

Who cannot join

Any finding of the medical examination considered clinically relevant by the Investigator
Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
Diagnosis of sickle cell anemia or known chronic anemia
History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)

Show all 14Show fewer

History of relevant allergy/hypersensitivity
Intake of drugs with a long half life (>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
Alcohol abuse, drug abuse
Any laboratory value of clinical relevance that is outside an acceptable range
Change of drug dosing of allowed co medication
Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
Serum creatinine above upper limit normal at screening

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

1218.55.0005 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1218.55.0006 Boehringer Ingelheim Investigational Site
Cypress, California
1218.55.0001 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.55.0008 Boehringer Ingelheim Investigational Site
DeLand, Florida
1218.55.0004 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.55.0003 Boehringer Ingelheim Investigational Site
New York, New York

Other trials in United States

About this study

Official title: An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days

Conditions: Diabetes Mellitus, Type 2
Being tested: linagliptin QD (once daily) for 7 days
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.

linagliptin QD (once daily) for 7 daysDrug
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

Study groups in NCT00935220
Study group	Role	What they receive
linagliptin	Experimental	Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation Receives: Drug: linagliptin QD (once daily) for 7 days

What is being measured

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

Linagliptin: AUC_τ,ss
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Measured: 24 hours
Linagliptin: C_max,ss
maximum concentration of linagliptin in plasma at steady state
Measured: 24 hours
DPP-4 Inhibition: E_24,ss
Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
Measured: One single measurement 24 h after drug administration under steady state conditions

Secondary outcomes (6)

Treatment Emergent Adverse Events
Frequency of patients with AEs
Measured: 21 days
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
Measured: 21 days
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
Measured: 21 days
Linagliptin: AUC_0-24
area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
Measured: 24 hours
Linagliptin: C_max
maximum concentration of linagliptin in plasma on Day 1
Measured: 24h
DPP-4 Inhibition: E_24
Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
Measured: One single measurement 24 h after drug administration

Timeline

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

Jun 2009Aug 2010

First posted8 Jul 2009 (estimated)
Study startJun 2009
Primary completionAug 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 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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00935220
Sponsor's protocol ID: 1218.55
Status last verified: Feb 2014
First submitted: 1 Jul 2009
Last updated: 27 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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days
ClinicalTrials.gov ID: NCT00935220
Acronym / sponsor ID: 1218.55
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Aug 2010 (actual)
First posted: 8 Jul 2009 (estimated)
Results: Posted 10 Nov 2011

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
linagliptin	Experimental	Drug: linagliptin QD (once daily) for 7 daysPharmacokinetic (PK)/Pharmacodynamic (PD) investigation

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Glycosylated haemoglobin >=7 and <= 10%
Age >=21 and <= 65
Body Mass Index >=18.5 and <=38 kg/m2
African American origin
Signed and dated informed consent prior to admission to the study

Key exclusion criteria (14 listed)

Any finding of the medical examination considered clinically relevant by the Investigator
Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
Diagnosis of sickle cell anemia or known chronic anemia

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 QD (once daily) for 7 daysdipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration	Drug	linagliptin

Primary outcome

Linagliptin: AUC_τ,ss
Time frame: 24 hours
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Linagliptin: C_max,ss
Time frame: 24 hours
maximum concentration of linagliptin in plasma at steady state
DPP-4 Inhibition: E_24,ss
Time frame: One single measurement 24 h after drug administration under steady state conditions
Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.

6 secondary outcomes

Treatment Emergent Adverse Events
Time frame: 21 days
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Time frame: 21 days
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Time frame: 21 days
Linagliptin: AUC_0-24
Time frame: 24 hours
Linagliptin: C_max
Time frame: 24h
DPP-4 Inhibition: E_24
Time frame: One single measurement 24 h after drug administration

Results and safety

Results posted to the registry on 10 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Linagliptin 5mg	41	39

Primary outcome: Linagliptin: AUC_τ,ss

Time frame: 24 hours. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Linagliptin 5mg n = 39
Value	194 (25.8)

Population analysed: Treated set

Primary outcome: Linagliptin: C_max,ss

Time frame: 24 hours. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Linagliptin 5mg n = 39
Value	16.4 (40.9)

Population analysed: Treated set

Primary outcome: DPP-4 Inhibition: E_24,ss

Time frame: One single measurement 24 h after drug administration under steady state conditions. Median (Full Range). Unit: Percent (of inhibition)

Measure	Linagliptin 5mg n = 37
Value	84.7 (72.2 to 91.9)

Population analysed: Treated set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linagliptin 5mg	0 of 41 (0%)	5 of 41 (12.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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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

6 sites 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 QD (once daily) for 7 days in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 6 sites 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 5 inclusion and 14 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 27 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 6 sites 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 10 Nov 2011). 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?

Linagliptin: AUC_τ,ss (time frame: 24 hours). 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 NCT00935220.

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 27 Jun 2014.