Diabetes Mellitus, Type 2Phase 2NCT00309608

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

A Phase 2 study testing Linagliptin and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 48 sites in 6 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

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Linagliptin and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 333 participants
Where: 48 sitesin 6 countries
Study dates: Apr 2006to Aug 2007
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

InclusionCriteria:
Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 7.5 10.0% at screening for patients treated with metformin alone
HbA1c 7.5 10.0% at beginning of the placebo run-in phase
Age > 21 and < 75 years
MI > 25 and < 40 kg/m2 (Body Mass Index)

Who cannot join

ExclusionCriteria:
Clinically relevant cardiovascular disease
Impaired hepatic function
Renal insufficiency or impaired renal function
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening

Trial locations and contacts

48 sites in 6 countries.

Country

City, postcode or hospital

48 sites in 6 countries

United Kingdom16 sites

1218.6.44012 Boehringer Ingelheim Investigational Site
Ashford
1218.6.44004 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
1218.6.44002 Boehringer Ingelheim Investigational Site
Bath
1218.6.44003 Boehringer Ingelheim Investigational Site
Birmingham
1218.6.44013 Boehringer Ingelheim Investigational Site
Camberley
1218.6.44016 Boehringer Ingelheim Investigational Site
Chorley
1218.6.44007 Boehringer Ingelheim Investigational Site
Dundee
1218.6.44006 Boehringer Ingelheim Investigational Site
Exeter
1218.6.44005 Boehringer Ingelheim Investigational Site
Gillingham
1218.6.44015 Boehringer Ingelheim Investigational Site
Glasgow
1218.6.44008 Boehringer Ingelheim Investigational Site
Guildford
1218.6.44017 Boehringer Ingelheim Investigational Site
Liverpool
1218.6.44001 Boehringer Ingelheim Investigational Site
London
1218.6.44018 Boehringer Ingelheim Investigational Site
Manchester
1218.6.44009 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
1218.6.44019 Boehringer Ingelheim Investigational Site
Reading

Other trials in United Kingdom

Germany15 sites

1218.6.49007 Boehringer Ingelheim Investigational Site
Aschaffenburg
1218.6.49013 Boehringer Ingelheim Investigational Site
Bosenheim
1218.6.49008 Boehringer Ingelheim Investigational Site
Dresden
1218.6.49009 Boehringer Ingelheim Investigational Site
Düsseldorf
1218.6.49014 Boehringer Ingelheim Investigational Site
Heidelberg
1218.6.49012 Boehringer Ingelheim Investigational Site
Immenstadt im Allgäu
1218.6.49001 Boehringer Ingelheim Investigational Site
Mainz
1218.6.49005 Boehringer Ingelheim Investigational Site
Neuwied
1218.6.49017 Boehringer Ingelheim Investigational Site
Offenbach A. M.
1218.6.49002 Boehringer Ingelheim Investigational Site
Saarbrücken
1218.6.49010 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1218.6.49011 Boehringer Ingelheim Investigational Site
Sinsheim
1218.6.49015 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg
1218.6.49016 Boehringer Ingelheim Investigational Site
Wangen
1218.6.49003 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

France5 sites

1218.6.3302A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.6.3303A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.6.3304A Boehringer Ingelheim Investigational Site
Joué-lès-Tours
1218.6.3305A Euraxi Pharma
Joué-lès-Tours
1218.6.3301A Boehringer Ingelheim Investigational Site
Paris

Other trials in France

Slovakia4 sites

1218.6.42103 Boehringer Ingelheim Investigational Site
Banská Bystrica
1218.6.42104 Boehringer Ingelheim Investigational Site
Bratislava
1218.6.42105 Boehringer Ingelheim Investigational Site
Bratislava
1218.6.42101 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom

Other trials in Slovakia

Sweden4 sites

1218.6.46003 Boehringer Ingelheim Investigational Site
Gothenburg
1218.6.46001 Boehringer Ingelheim Investigational Site
Malmö
1218.6.46002 Boehringer Ingelheim Investigational Site
Uddevalla
1218.6.46004 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Ukraine4 sites

1218.6.38002 Boehringer Ingelheim Investigational Site
Dnyepropetrovsk
1218.6.38001 Boehringer Ingelheim Investigational Site
Kiev
1218.6.38003 Boehringer Ingelheim Investigational Site
Kiev
1218.6.38005 Boehringer Ingelheim Investigational Site
Kiev

Other trials in Ukraine

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin, Placebo, Glimepiride
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
Linagliptin medium dose tablet once daily
LinagliptinDrug
Linagliptin high dose tablet once daily
LinagliptinDrug
Linagliptin low dose tablet once daily
PlaceboDrug
Placebo tablets once daily
GlimepirideDrug
Glimepiride tablets once daily

Study groups in NCT00309608
Study group	Role	What they receive
Linagliptin low dose	Experimental	Patients receive Linagliptin low dose tablets once daily Receives: Drug: Linagliptin
Linagliptin medium dose	Experimental	Patients receive Linagliptin medium dose tablets once daily Receives: Drug: Linagliptin
Linagliptin high dose	Experimental	Patients receive Linagliptin high dose tablets once daily Receives: Drug: Linagliptin
Placebo	Placebo comparator	Patients receive tablets identical to those containing Linagliptin low, medium and high dose Receives: Drug: Placebo
Glimepiride	Active comparator	Patients receive Glimepiride tablets once daily Receives: Drug: Glimepiride

What is being measured

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

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 HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Measured: Baseline and week 12

Secondary outcomes (2)

Percentage of Patients With HbA1c<=7.0% at Week 12
Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.
Measured: week 12
Fasting Blood Plasma Glucose Level (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

Timeline

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

Apr 2006Aug 2007

First posted3 Apr 2006 (estimated)
Study startApr 2006
Primary completionAug 2007

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00309608
Sponsor's protocol ID: 1218.6
Other IDs: 2005-004597-24, 2005
Status last verified: Dec 2013
First submitted: 31 Mar 2006
Last updated: 8 Jul 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 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.
ClinicalTrials.gov ID: NCT00309608
Acronym / sponsor ID: 1218.6
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Aug 2007 (actual)
First posted: 3 Apr 2006 (estimated)
Results: Posted 15 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: 5

Arm	Type	Receives
Linagliptin low dose	Experimental	Drug: LinagliptinPatients receive Linagliptin low dose tablets once daily
Linagliptin medium dose	Experimental	Drug: LinagliptinPatients receive Linagliptin medium dose tablets once daily
Linagliptin high dose	Experimental	Drug: LinagliptinPatients receive Linagliptin high dose tablets once daily
Placebo	Placebo comparator	Drug: PlaceboPatients receive tablets identical to those containing Linagliptin low, medium and high dose
Glimepiride	Active comparator	Drug: GlimepiridePatients receive Glimepiride tablets once daily

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 7.5 10.0% at screening for patients treated with metformin alone
HbA1c 7.5 10.0% at beginning of the placebo run-in phase
Age > 21 and < 75 years

Key exclusion criteria (6 listed)

Clinically relevant cardiovascular disease
Impaired hepatic function
Renal insufficiency or impaired renal function
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening

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
LinagliptinLinagliptin medium dose tablet once daily	Drug	Linagliptin medium dose
LinagliptinLinagliptin high dose tablet once daily	Drug	Linagliptin high dose
LinagliptinLinagliptin low dose tablet once daily	Drug	Linagliptin low dose
PlaceboPlacebo tablets once daily	Drug	Placebo
GlimepirideGlimepiride tablets once daily	Drug	Glimepiride

Primary outcome

HbA1c Change From Baseline at Week 12
Time frame: Baseline and week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.

2 secondary outcomes

Percentage of Patients With HbA1c<=7.0% at Week 12
Time frame: week 12
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
Time frame: Baseline and week 12

Results and safety

Results posted to the registry on 15 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	71	57
Linagliptin 1 mg	65	52
Linagliptin 5 mg	66	56
Linagliptin 10 mg	66	60
Glimepiride	65	61

Primary outcome: HbA1c Change From Baseline at Week 12

Time frame: Baseline and week 12. Mean (Standard Error). Unit: Percent

Measure	Placebo n = 70	Linagliptin 1 mg n = 64	Linagliptin 5 mg n = 62	Linagliptin 10 mg n = 66	Glimepiride n = 64
Value	0.25 (0.10)	-0.15 (0.10)	-0.48 (0.11)	-0.42 (0.10)	-0.59 (0.10)

Placebo vs Linagliptin 10 mg: Mean Difference (Final Values): -0.67 (95% CI -0.95 to -0.39), p <0.0001, Pairwise comparison based on ANCOVA
Placebo vs Linagliptin 5 mg: Mean Difference (Final Values): -0.73 (95% CI -1.01 to -0.44), p <0.0001, Pairwise comparison based on ANCOVA
Placebo vs Linagliptin 1 mg: Mean Difference (Final Values): -0.4 (95% CI -0.68 to -0.12), p = 0.0055, Pairwise comparison based on 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Weeks + 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 71 (1.4%)	10 of 71 (14.1%)	Not reported
Linagliptin 1 mg	3 of 65 (4.6%)	4 of 65 (6.2%)	Not reported
Linagliptin 5 mg	1 of 66 (1.5%)	8 of 66 (12.1%)	Not reported
Linagliptin 10 mg	4 of 66 (6.1%)	8 of 66 (12.1%)	Not reported
Glimepiride	1 of 65 (1.5%)	4 of 65 (6.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Not yet recruitingPhase 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

48 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Linagliptin and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 48 sites in 6 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 7 inclusion and 6 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United Kingdom, Germany, France, Slovakia, Sweden and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 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 12 (time frame: Baseline and week 12). 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 NCT00309608.

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 8 Jul 2014.