Diabetes Mellitus, Type 2Phase 3NCT00641043

Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

A Phase 3 study testing Linagliptin + pioglitazone (30 mg) in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 43 sites in 7 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

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control. 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 + pioglitazone (30 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 389 participants
Where: 43 sitesin 7 countries
Study dates: Mar 2008to Jun 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

Signed and dated written Informed Consent (IC) by date of Visit 1a in accordance with Good Clinical Practice (GCP) and local legislation
Patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.
Glycosylated haemoglobin A1 (HbA1c) 7.5-11% at Visit 2 (Start of Run-in).
Male and female patients aged > or = 18 and < or = to 80 years at Visit 1a (Screening).
Body Mass Index (BMI) < or = 40 kg/m2 at Visit 1a (Screening)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Who cannot join

Myocardial infarction, stroke or Transient Isquemic Atack (TIA) within 6 months prior to Inform Consent (IC)
Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
Treatment with insulin within 3 months prior to IC
Treatment with anti-obesity drugs 3 months prior to IC.

Show all 17Show fewer

Alcohol abuse within the 3 months prior to IC that would interfere with trial participation or drug abuse.
Participation in another trial with an investigational drug within 2 months prior to IC.
Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
Pre-menopausal women (last menstruation < or =1 year prior to signing IC) who:
are nursing or pregnant,
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
Diabetic ketoacidosis within 6 months prior to IC.
Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.

Trial locations and contacts

43 sites in 7 countries.

Country

City, postcode or hospital

43 sites in 7 countries

Spain13 sites

1218.15.34002 Boehringer Ingelheim Investigational Site
Badalona
1218.15.34011 Boehringer Ingelheim Investigational Site
Badia Del Vallés
1218.15.34001 Boehringer Ingelheim Investigational Site
Bercelona
1218.15.34012 Boehringer Ingelheim Investigational Site
Borges Del Camp
1218.15.34013 Boehringer Ingelheim Investigational Site
Centelles
1218.15.34007 Boehringer Ingelheim Investigational Site
Granada
1218.15.34008 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.15.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.15.34004 Boehringer Ingelheim Investigational Site
Madrid
1218.15.34006 Boehringer Ingelheim Investigational Site
Madrid
1218.15.34010 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós (Barcelona)
1218.15.34005 Boehringer Ingelheim Investigational Site
Seville
1218.15.34014 Boehringer Ingelheim Investigational Site
Vic (Barcelona)

Other trials in Spain

Greece8 sites

1218.15.30004 Boehringer Ingelheim Investigational Site
Athens
1218.15.30007 Boehringer Ingelheim Investigational Site
Athens
1218.15.30017 Boehringer Ingelheim Investigational Site
Ioannina
1218.15.30002 Boehringer Ingelheim Investigational Site
Melissia-Athens
1218.15.30003 Boehringer Ingelheim Investigational Site
Nikaia
1218.15.30006 Boehringer Ingelheim Investigational Site
Thessaloniki
1218.15.30014 Boehringer Ingelheim Investigational Site
Thessaloniki
1218.15.30016 Boehringer Ingelheim Investigational Site
Thessaloniki

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Hungary6 sites

1218.15.36003 Boehringer Ingelheim Investigational Site
Budapest
1218.15.36004 Boehringer Ingelheim Investigational Site
Budapest
1218.15.36006 Boehringer Ingelheim Investigational Site
Budapest
1218.15.36008 Boehringer Ingelheim Investigational Site
Debrecen
1218.15.36005 Boehringer Ingelheim Investigational Site
Győr
1218.15.36002 Boehringer Ingelheim Investigational Site
Szombathely

Other trials in Hungary

Japan5 sites

1218.15.81001 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo
1218.15.81005 Boehringer Ingelheim Investigational Site
Koganei, Tokyo
1218.15.81002 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.15.81004 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1218.15.81003 Boehringer Ingelheim Investigational Site
Suita, Osaka,

Other trials in Japan

Romania5 sites

1218.15.40504 Boehringer Ingelheim Investigational Site
Alba Iulia
1218.15.40501 Boehringer Ingelheim Investigational Site
Bucharest
1218.15.40502 Boehringer Ingelheim Investigational Site
Bucharest
1218.15.40503 Boehringer Ingelheim Investigational Site
Sibiu
1218.15.40505 Boehringer Ingelheim Investigational Site
Târgu Mureş

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Austria4 sites

1218.15.43004 Boehringer Ingelheim Investigational Site
Feldkirch
1218.15.43001 Boehringer Ingelheim Investigational Site
Graz
1218.15.43003 Boehringer Ingelheim Investigational Site
Vienna
1218.15.43005 Boehringer Ingelheim Investigational Site
Vienna

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Portugal2 sites

1218.15.35007 Boehringer Ingelheim Investigational Site
Aveiro
1218.15.35001 Boehringer Ingelheim Investigational Site
Lisbon

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About this study

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.

Conditions: Diabetes Mellitus, Type 2
Being tested: placebo + pioglitazone (30 mg), Linagliptin + pioglitazone (30 mg)
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.

placebo + pioglitazone (30 mg)Drug
placebo + overcapsulated 30 mg tablet, once daily
Linagliptin + pioglitazone (30 mg)Drug
5 mg tablet + overcapsulated 30 mg tablet, once daily

Study groups in NCT00641043
Study group	Role	What they receive
BI 1356 (5 mg)	Experimental	BI 1356 5mg in initial combination therapy with pioglitazone 30 mg Receives: Drug: Linagliptin + pioglitazone (30 mg)
Placebo matching BI 1356 5 mg	Placebo comparator	Placebo in initial combination therapy with pioglitazone 30 mg Receives: Drug: placebo + pioglitazone (30 mg)

What is being measured

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

HbA1c Change From Baseline to 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 (12)

HbA1c Change From Baseline to 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 to 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 to 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 to 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 to 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 to 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 to 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-diabetes 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% 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 above 7%. 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% 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 above 7%.
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 above 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 above 6.5%
Measured: Baseline and week 24
Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24
The percentage of patients with an HbA1c reduction from baseline greater than 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

Timeline

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

Mar 2008Jun 2009

First posted21 Mar 2008 (estimated)
Study startMar 2008
Primary completionJun 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 (1)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: 389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00641043
Sponsor's protocol ID: 1218.15
Other IDs: 2007-002456-41
Status last verified: Jan 2014
First submitted: 29 Feb 2008
Last updated: 17 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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 Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.
ClinicalTrials.gov ID: NCT00641043
Acronym / sponsor ID: 1218.15
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jun 2009 (actual)
First posted: 21 Mar 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.

Study design

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

Arm	Type	Receives
BI 1356 (5 mg)	Experimental	Drug: Linagliptin + pioglitazone (30 mg)BI 1356 5mg in initial combination therapy with pioglitazone 30 mg
Placebo matching BI 1356 5 mg	Placebo comparator	Drug: placebo + pioglitazone (30 mg)Placebo in initial combination therapy with pioglitazone 30 mg

Who may qualify

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

Key inclusion criteria (6 listed)

Signed and dated written Informed Consent (IC) by date of Visit 1a in accordance with Good Clinical Practice (GCP) and local legislation
Patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.
Glycosylated haemoglobin A1 (HbA1c) 7.5-11% at Visit 2 (Start of Run-in).
Male and female patients aged > or = 18 and < or = to 80 years at Visit 1a (Screening).
Body Mass Index (BMI) < or = 40 kg/m2 at Visit 1a (Screening)

Key exclusion criteria (17 listed)

Myocardial infarction, stroke or Transient Isquemic Atack (TIA) within 6 months prior to Inform Consent (IC)
Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
Treatment with insulin within 3 months prior to IC

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
placebo + pioglitazone (30 mg)placebo + overcapsulated 30 mg tablet, once daily	Drug	Placebo matching BI 1356 5 mg
Linagliptin + pioglitazone (30 mg)5 mg tablet + overcapsulated 30 mg tablet, once daily	Drug	BI 1356 (5 mg)

Primary outcome

HbA1c Change From Baseline to 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.

12 secondary outcomes

HbA1c Change From Baseline to Week 6
Time frame: Baseline and week 6
HbA1c Change From Baseline to Week 12
Time frame: Baseline and week 12
HbA1c Change From Baseline to Week 18
Time frame: Baseline and week 18
FPG Change From Baseline to Week 24
Time frame: Baseline and week 24
FPG Change From Baseline to Week 6
Time frame: Baseline and week 6
FPG Change From Baseline to Week 12
Time frame: Baseline and week 12
FPG Change From Baseline to 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 Who Have an HbA1c Lowering by 0.5% 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 + Pioglitazone	130	111
Linagliptin + Pioglitazone	259	244

Primary outcome: HbA1c Change From Baseline to Week 24

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

Measure	Placebo + Pioglitazone n = 128	Linagliptin + Pioglitazone n = 252
Value	-0.56 (0.09)	-1.06 (0.06)

Placebo + Pioglitazone vs Linagliptin + Pioglitazone: Mean Difference (Final Values): -0.51 (95% CI -0.71 to -0.30), 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.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first dose until 7 days after last dose, up to 202 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Pioglitazone	3 of 130 (2.3%)	21 of 130 (16.2%)	Not reported
Linagliptin + Pioglitazone	8 of 259 (3.1%)	33 of 259 (12.7%)	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 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

43 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin + pioglitazone (30 mg) in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 43 sites in 7 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 6 inclusion and 17 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 43 sites in Spain, Greece, Hungary, Japan, Romania and 2 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 to 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 NCT00641043, which also lists 1 linked publication.

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.