Diabetes Mellitus, Type 2Phase 3NCT00621140

Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 69 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To investigate efficacy, safety and tolerability of BI 1356 versus placebo Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: linagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 503 participants
Where: 69 sitesin 11 countries
Study dates: Feb 2008to May 2009
Phase: Phase 3
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients with type 2 diabetes and insufficient glycaemic control.
Age 18 or over and not older than 80 years

Who cannot join

Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Trial locations and contacts

69 sites in 11 countries.

Country

City, postcode or hospital

69 sites in 11 countries

India14 sites

1218.16.91009 Boehringer Ingelheim Investigational Site
Andhra Pradesh
1218.16.91002 Boehringer Ingelheim Investigational Site
Bangalore
1218.16.91005 Boehringer Ingelheim Investigational Site
Bangalore
1218.16.91014 Boehringer Ingelheim Investigational Site
Chennai
1218.16.91013 Boehringer Ingelheim Investigational Site
Ghaziabad
1218.16.91010 Boehringer Ingelheim Investigational Site
Hyderabad
1218.16.91006 Boehringer Ingelheim Investigational Site
Jaipur
1218.16.91011 Boehringer Ingelheim Investigational Site
Maharashtra
1218.16.91008 Boehringer Ingelheim Investigational Site
Mangalore
1218.16.91007 Boehringer Ingelheim Investigational Site
Manipal
1218.16.91004 Boehringer Ingelheim Investigational Site
Mumbai
1218.16.91003 Boehringer Ingelheim Investigational Site
Nashik
1218.16.91012 Boehringer Ingelheim Investigational Site
Tamilnadu
1218.16.91001 Boehringer Ingelheim Investigational Site
Trivandrum, Kerala

Other trials in India

Ukraine12 sites

1218.16.38011 Boehringer Ingelheim Investigational Site
Dnipro
1218.16.38002 Boehringer Ingelheim Investigational Site
Kharkiv
1218.16.38004 Boehringer Ingelheim Investigational Site
Kharkiv
1218.16.38010 Boehringer Ingelheim Investigational Site
Kharkiv
1218.16.38001 Boehringer Ingelheim Investigational Site
Kiev
1218.16.38005 Boehringer Ingelheim Investigational Site
Kiev
1218.16.38008 Boehringer Ingelheim Investigational Site
Kiev
1218.16.38009 Boehringer Ingelheim Investigational Site
Kiev
1218.16.38012 Boehringer Ingelheim Investigational Site
Kiev
1218.16.38003 Boehringer Ingelheim Investigational Site
Lviv
1218.16.38006 Boehringer Ingelheim Investigational Site
Vinnitsa
1218.16.38007 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Netherlands10 sites

1218.16.31009 Boehringer Ingelheim Investigational Site
Andijk
1218.16.31024 Boehringer Ingelheim Investigational Site
Castricum
1218.16.31006 Boehringer Ingelheim Investigational Site
Deurne
1218.16.31001 Boehringer Ingelheim Investigational Site
Ewijk
1218.16.31010 Boehringer Ingelheim Investigational Site
Losser
1218.16.31003 Boehringer Ingelheim Investigational Site
Oude Pekela
1218.16.31021 Boehringer Ingelheim Investigational Site
Poortvliet
1218.16.31004 Boehringer Ingelheim Investigational Site
Rijswijk
1218.16.31008 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1218.16.31002 Boehringer Ingelheim Investigational Site
Wildervank

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Malaysia7 sites

1218.16.60006 Boehringer Ingelheim Investigational Site
Alor Star
1218.16.60003 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru
1218.16.60001 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1218.16.60002 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1218.16.60004 Boehringer Ingelheim Investigational Site
Perak
1218.16.60005 Boehringer Ingelheim Investigational Site
Perak
1218.16.60007 Boehringer Ingelheim Investigational Site
Pulau Pinang

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Israel6 sites

1218.16.97267 Boehringer Ingelheim Investigational Site
Giv‘atayim
1218.16.97263 Boehringer Ingelheim Investigational Site
Haifa
1218.16.97265 Boehringer Ingelheim Investigational Site
Holon
1218.16.97261 Boehringer Ingelheim Investigational Site
Jerusalem
1218.16.97262 Boehringer Ingelheim Investigational Site
Nahariya
1218.16.97266 Boehringer Ingelheim Investigational Site
Safed

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Slovakia6 sites

1218.16.42103 Boehringer Ingelheim Investigational Site
Banská Bystrica
1218.16.42102 Boehringer Ingelheim Investigational Site
Bratislava
1218.16.42104 Boehringer Ingelheim Investigational Site
Bratislava
1218.16.42105 Boehringer Ingelheim Investigational Site
Bratislava
1218.16.42101 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom
1218.16.42106 Boehringer Ingelheim Investigational Site
Šamorín

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Italy5 sites

1218.16.39004 Boehringer Ingelheim Investigational Site
Catanzaro
1218.16.39008 Boehringer Ingelheim Investigational Site
Genova
1218.16.39002 Boehringer Ingelheim Investigational Site
Milan
1218.16.39001 Boehringer Ingelheim Investigational Site
Pisa
1218.16.39006 Boehringer Ingelheim Investigational Site
Roma

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Poland3 sites

1218.16.48603 Boehringer Ingelheim Investigational Site
Lublin
1218.16.48601 Boehringer Ingelheim Investigational Site
Warsaw
1218.16.48604 Boehringer Ingelheim Investigational Site
Zabrze

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Croatia2 sites

1218.16.38605 Boehringer Ingelheim Investigational Site
Krapinske Toplice
1218.16.38604 Boehringer Ingelheim Investigational Site
Slavonski Brod

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Romania2 sites

1218.16.40604 Boehringer Ingelheim Investigational Site
Brasov
1218.16.40603 Boehringer Ingelheim Investigational Site
Galati

Other trials in Romania

Thailand2 sites

1218.16.66001 Boehringer Ingelheim Investigational Site
Bangkok
1218.16.66002 Boehringer Ingelheim Investigational Site
Khon Kaen

Other trials in Thailand

About this study

Official title: A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Conditions: Diabetes Mellitus, Type 2
Being tested: linagliptin, placebo
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.

linagliptinDrug
active
placeboDrug
placebo

Study groups in NCT00621140
Study group	Role	What they receive
linagliptin 5 mg	Experimental	linagliptin 5 mg once daily Receives: Drug: linagliptin
placebo	Placebo comparator	placebo matching linagliptin 5 mg tablets Receives: Drug: placebo

What is being measured

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

HbA1c Change From Baseline at Week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 24

Secondary outcomes (13)

HbA1c Change From Baseline at Week 6
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 6
HbA1c Change From Baseline at Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 12
HbA1c Change From Baseline at Week 18
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 18
FPG Change From Baseline at Week 24
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 24
FPG Change From Baseline at Week 6
This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 6
FPG Change From Baseline at Week 12
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 12
FPG Change From Baseline at Week 18
This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 18
Percentage of Patients With HbA1c <7.0% at Week 24
The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%
Measured: Baseline and week 24
Percentage of Patients With HbA1c<7.0% at Week 24
The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.
Measured: Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.
Measured: Baseline and week 24
Percentage of Patients With HbA1c<6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.
Measured: Baseline and week 24
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24
The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.
Measured: Baseline and week 24
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
Measured: Baseline and week 24

Timeline

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

Feb 2008May 2009

First posted22 Feb 2008 (estimated)
Study startFeb 2008
Primary completionMay 2009

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 503 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621140
Sponsor's protocol ID: 1218.16
Other IDs: 2007-002448-10
Status last verified: Jan 2014
First submitted: 14 Jan 2008
Last updated: 17 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
PubMed 27484756
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
PubMed 22234149

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 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
ClinicalTrials.gov ID: NCT00621140
Acronym / sponsor ID: 1218.16
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 503 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: May 2009 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 7 Jun 2011

Clinical summary

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

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
linagliptin 5 mg	Experimental	Drug: linagliptinlinagliptin 5 mg once daily
placebo	Placebo comparator	Drug: placeboplacebo matching linagliptin 5 mg tablets

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female patients with type 2 diabetes and insufficient glycaemic control.
Age 18 or over and not older than 80 years

Key exclusion criteria (2 listed)

Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

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
linagliptinactive	Drug	linagliptin 5 mg
placeboplacebo	Drug	placebo

Primary outcome

HbA1c Change From Baseline at Week 24
Time frame: Baseline and week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

13 secondary outcomes

HbA1c Change From Baseline at Week 6
Time frame: Baseline and week 6
HbA1c Change From Baseline at Week 12
Time frame: Baseline and week 12
HbA1c Change From Baseline at Week 18
Time frame: Baseline and week 18
FPG Change From Baseline at Week 24
Time frame: Baseline and week 24
FPG Change From Baseline at Week 6
Time frame: Baseline and week 6
FPG Change From Baseline at Week 12
Time frame: Baseline and week 12
FPG Change From Baseline at Week 18
Time frame: Baseline and week 18
Percentage of Patients With HbA1c <7.0% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c<7.0% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c<6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24
Time frame: Baseline and week 24
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
Time frame: Baseline and week 24

Results and safety

Results posted to the registry on 7 Jun 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
Placebo	167	152
Linagliptin	336	318

Primary outcome: HbA1c Change From Baseline at Week 24

Time frame: Baseline and week 24. Mean (Standard Error). Unit: Percent

Measure	Placebo n = 163	Linagliptin n = 333
Value	0.25 (0.07)	-0.44 (0.05)

Placebo vs Linagliptin: Mean Difference (Final Values): -0.69 (95% CI -0.85 to -0.53), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first drug dose until 7 days after last dose, an average of 167 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 167 (4.2%)	38 of 167 (22.8%)	Not reported
Linagliptin	10 of 336 (3%)	29 of 336 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27484756Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
Derived from this study: PubMed 22234149Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

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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

69 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 69 sites in 11 countries.

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 2 inclusion and 2 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 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in India, Ukraine, Netherlands, Malaysia, Israel and 6 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Jun 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?

HbA1c Change From Baseline at Week 24 (time frame: Baseline and week 24). 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 NCT00621140, which also lists 2 linked publications.

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 17 Feb 2014.