Diabetes Mellitus, Type 2Phase 3NCT01084005

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 34 sites in 5 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 linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control Read more about this study

Who is it for?: Ages 70 years and older
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: 241 participants
Where: 34 sitesin 5 countries
Study dates: Mar 2010to Jun 2011
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 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Type 2 diabetes mellitus
HbA1c >= 7.0%
Age >= 70 years
Signed and dated written informed consent

Who cannot join

Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Impaired hepatic function
Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
Treatment with anti-obesity drugs

Trial locations and contacts

34 sites in 5 countries.

Country

City, postcode or hospital

34 sites in 5 countries

Canada8 sites

1218.63.10003 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.63.10005 Boehringer Ingelheim Investigational Site
Hawkesbury, Ontario
1218.63.10001 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1218.63.10007 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1218.63.10002 Boehringer Ingelheim Investigational Site
Saint Romuald, Quebec
1218.63.10004 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1218.63.10006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.63.10008 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Denmark8 sites

1218.63.45007 Boehringer Ingelheim Investigational Site
Aalborg
1218.63.45002 Boehringer Ingelheim Investigational Site
Aarhus C
1218.63.45003 Boehringer Ingelheim Investigational Site
Aarhus C
1218.63.45001 Boehringer Ingelheim Investigational Site
Birkerød
1218.63.45008 Boehringer Ingelheim Investigational Site
Hellerup
1218.63.45006 Boehringer Ingelheim Investigational Site
Hillerød
1218.63.45004 Boehringer Ingelheim Investigational Site
Hvidovre
1218.63.45005 Bispebjerg Hospital
København NV

Other trials in Denmark

Australia7 sites

1218.63.61003 Boehringer Ingelheim Investigational Site
Adelaide, South Australia
1218.63.61002 Boehringer Ingelheim Investigational Site
Daw Park, South Australia
1218.63.61007 Boehringer Ingelheim Investigational Site
East Ringwood, Victoria
1218.63.61005 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
1218.63.61006 Boehringer Ingelheim Investigational Site
Herston, Queensland
1218.63.61001 Boehringer Ingelheim Investigational Site
Parkville, Victoria
1218.63.61004 Boehringer Ingelheim Investigational Site
Reservoir, Victoria

Other trials in Australia

Netherlands6 sites

1218.63.31008 Boehringer Ingelheim Investigational Site
Beek en Donk
1218.63.31007 Boehringer Ingelheim Investigational Site
Beerzerveld
1218.63.31012 Boehringer Ingelheim Investigational Site
Doetinchem
1218.63.31014 Boehringer Ingelheim Investigational Site
Etten-Leur
1218.63.31009 Boehringer Ingelheim Investigational Site
Oude Pekela
1218.63.31001 Boehringer Ingelheim Investigational Site
Tubbergen

Other trials in Netherlands

Sweden5 sites

1218.63.46004 Boehringer Ingelheim Investigational Site
Gothenburg
1218.63.46003 Boehringer Ingelheim Investigational Site
Järfälla
1218.63.46001 Boehringer Ingelheim Investigational Site
Malmö
1218.63.46002 Boehringer Ingelheim Investigational Site
Sundsvall
1218.63.46005 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

About this study

Official title: A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy

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
patients receive linagliptin 5 mg tablets once daily
placeboDrug
patients receive placebo matching linagliptin 5 mg once daily

Study groups in NCT01084005
Study group	Role	What they receive
linagliptin	Experimental	patients receive linagliptin 5 mg tablets once daily Receives: Drug: linagliptin
placebo	Placebo comparator	patients receive placebo tablets matching linagliptin 5 mg once daily Receives: Drug: placebo

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 prior use of insulin.
Measured: Baseline and week 24

Secondary outcomes (11)

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 prior use of insulin.
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 prior use of insulin.
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 prior use of insulin.
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 prior use of insulin.
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 prior use of insulin, week repeated within patient and week by treatment interaction.
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 prior use of insulin, week repeated within patient and week by treatment interaction.
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 prior use of insulin, week repeated within patient and week by treatment interaction.
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 were 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 Who Have a HbA1c Lowering by at Least 0.5% at Week 24
The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline 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
Number of Patients With Rescue Therapy
The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial
Measured: week 24

Timeline

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

Mar 2010Jun 2011

First posted10 Mar 2010 (estimated)
Study startMar 2010
Primary completionJun 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.
Publications (3)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: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01084005
Sponsor's protocol ID: 1218.63
Other IDs: 2009-015255-25, 2009
Status last verified: Dec 2013
First submitted: 9 Mar 2010
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
PubMed 25236917
McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
PubMed 24169807
Barnett AH, Huisman H, Jones R, von Eynatten M, Patel S, Woerle HJ. Linagliptin for patients aged 70 years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1413-23. doi: 10.1016/S0140-6736(13)61500-7. Epub 2013 Aug 13.
PubMed 23948125

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 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy
ClinicalTrials.gov ID: NCT01084005
Acronym / sponsor ID: 1218.63
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Mar 2010
Primary completion: Jun 2011 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 18 Jul 2012

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
linagliptin	Experimental	Drug: linagliptinpatients receive linagliptin 5 mg tablets once daily
placebo	Placebo comparator	Drug: placebopatients receive placebo tablets matching linagliptin 5 mg once daily

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes mellitus
HbA1c >= 7.0%
Age >= 70 years
Signed and dated written informed consent

Key exclusion criteria (4 listed)

Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Impaired hepatic function
Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
Treatment with anti-obesity drugs

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
linagliptinpatients receive linagliptin 5 mg tablets once daily	Drug	linagliptin
placebopatients receive placebo matching linagliptin 5 mg once daily	Drug	placebo

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 prior use of insulin.

11 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 Who Have a HbA1c Lowering by at Least 0.5% at Week 24
Time frame: Baseline and week 24
Number of Patients With Rescue Therapy
Time frame: week 24

Results and safety

Results posted to the registry on 18 Jul 2012, 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	79	74
Linagliptin 5 mg	162	146

Primary outcome: HbA1c Change From Baseline to Week 24

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

Measure	Placebo n = 78	Linagliptin 5 mg n = 160
Value	0.04 (0.07)	-0.61 (0.06)

Placebo vs Linagliptin 5 mg: Mean Difference (Final Values): -0.64 (95% CI -0.81 to -0.48), p <0.0001, ANCOVA

Population analysed: FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks + 7 days of follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 79 (6.3%)	37 of 79 (46.8%)	Not reported
Linagliptin 5 mg	14 of 162 (8.6%)	70 of 162 (43.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25236917Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
Derived from this study: PubMed 24169807McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
Derived from this study: PubMed 23948125Barnett AH, Huisman H, Jones R, von Eynatten M, Patel S, Woerle HJ. Linagliptin for patients aged 70 years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1413-23. doi: 10.1016/S0140-6736(13)61500-7. Epub 2013 Aug 13.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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

34 sites in 5 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 34 sites in 5 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 4 inclusion and 4 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Canada, Denmark, Australia, Netherlands, Sweden. 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 18 Jul 2012). 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 NCT01084005, which also lists 3 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 29 Jan 2014.