Diabetes Mellitus, Type 2Phase 3NCT00954447

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

A Phase 3 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 169 sites in 19 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 during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control. Read more about this study

Who is it for?: Ages 18 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: 1,263 participants
Where: 169 sitesin 19 countries
Study dates: Aug 2009to Sep 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetes type 2, detectable C-peptide, HbA1c 7-10%
Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Who cannot join

Uncontrolled hyperglycemia during Run-in
Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Liver impairment; gastric surgery; medical history of cancer in last 5 years
Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
Unsufficient birth control, pregnancy and nursing

Trial locations and contacts

169 sites in 19 countries.

Country

City, postcode or hospital

169 sites in 19 countries

United States47 sites

1218.36.01019 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania
1218.36.01036 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1218.36.01041 Boehringer Ingelheim Investigational Site
Bennington, Vermont
1218.36.01006 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1218.36.01014 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1218.36.01015 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1218.36.01034 Boehringer Ingelheim Investigational Site
City of Saint Peters, Missouri
1218.36.01054 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1218.36.01038 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.36.01047 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1218.36.01043 Boehringer Ingelheim Investigational Site
Escondido, California
1218.36.01051 Boehringer Ingelheim Investigational Site
Escondido, California
1218.36.01065 Boehringer Ingelheim Investigational Site
Fresno, California
1218.36.01021 Boehringer Ingelheim Investigational Site
Greenbrae, California
1218.36.01004 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.36.01025 Boehringer Ingelheim Investigational Site
Hickory, North Carolina
1218.36.01055 Boehringer Ingelheim Investigational Site
Honolulu, Hawaii
1218.36.01016 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.36.01035 Boehringer Ingelheim Investigational Site
Inverness, Florida
1218.36.01040 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1218.36.01003 Boehringer Ingelheim Investigational Site
Kingsport, Tennessee
1218.36.01024 Boehringer Ingelheim Investigational Site
Lakewood, Washington
1218.36.01013 Boehringer Ingelheim Investigational Site
Los Angeles, California
1218.36.01048 Boehringer Ingelheim Investigational Site
Los Angeles, California
1218.36.01010 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.36.01053 Boehringer Ingelheim Investigational Site
New Hartford, New York
1218.36.01042 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
1218.36.01012 Boehringer Ingelheim Investigational Site
Norristown, Pennsylvania
1218.36.01018 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1218.36.01011 Boehringer Ingelheim Investigational Site
Paducah, Kentucky
1218.36.01063 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1218.36.01037 Boehringer Ingelheim Investigational Site
Ponte Vedra, Florida
1218.36.01007 Boehringer Ingelheim Investigational Site
Renton, Washington
1218.36.01064 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1218.36.01009 Boehringer Ingelheim Investigational Site
Roswell, Georgia
1218.36.01032 Boehringer Ingelheim Investigational Site
Saint Cloud, Florida
1218.36.01026 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1218.36.01058 Boehringer Ingelheim Investigational Site
San Diego, California
1218.36.01008 Boehringer Ingelheim Investigational Site
Santa Ana, California
1218.36.01020 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1218.36.01027 Boehringer Ingelheim Investigational Site
Spokane, Washington
1218.36.01029 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1218.36.01049 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1218.36.01005 Boehringer Ingelheim Investigational Site
Statesville, North Carolina
1218.36.01062 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1218.36.01039 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1218.36.01056 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut

Other trials in United States

Germany16 sites

1218.36.49001 Boehringer Ingelheim Investigational Site
Berlin
1218.36.49002 Boehringer Ingelheim Investigational Site
Berlin
1218.36.49010 Boehringer Ingelheim Investigational Site
Berlin
1218.36.49009 Boehringer Ingelheim Investigational Site
Bosenheim
1218.36.49017 Boehringer Ingelheim Investigational Site
Cologne
1218.36.49004 Boehringer Ingelheim Investigational Site
Dortmund
1218.36.49006 Boehringer Ingelheim Investigational Site
Dresden
1218.36.49012 Boehringer Ingelheim Investigational Site
Magdeburg
1218.36.49005 Boehringer Ingelheim Investigational Site
Mainz
1218.36.49018 Boehringer Ingelheim Investigational Site
Neuwied
1218.36.49008 Boehringer Ingelheim Investigational Site
Pirna
1218.36.49019 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg
1218.36.49003 Boehringer Ingelheim Investigational Site
Unterschneidheim
1218.36.49011 Boehringer Ingelheim Investigational Site
Wangen
1218.36.49014 Boehringer Ingelheim Investigational Site
Wangen
1218.36.49015 Boehringer Ingelheim Investigational Site
Westerkappeln

Other trials in Germany

Canada11 sites

1218.36.02010 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.36.02002 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1218.36.02009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.36.02005 Boehringer Ingelheim Investigational Site
Kingston, Ontario
1218.36.02001 Boehringer Ingelheim Investigational Site
Laval, Quebec
1218.36.02003 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1218.36.02008 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.36.02006 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1218.36.02007 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.36.02004 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.36.02011 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

South Korea10 sites

1218.36.82004 Boehringer Ingelheim Investigational Site
Daegu
1218.36.82009 Boehringer Ingelheim Investigational Site
Daegu
1218.36.82008 Boehringer Ingelheim Investigational Site
Incheon
1218.36.82007 Boehringer Ingelheim Investigational Site
Jeonju
1218.36.82001 Boehringer Ingelheim Investigational Site
Pusan
1218.36.82002 Boehringer Ingelheim Investigational Site
Seoul
1218.36.82003 Boehringer Ingelheim Investigational Site
Seoul
1218.36.82005 Boehringer Ingelheim Investigational Site
Seoul
1218.36.82006 Boehringer Ingelheim Investigational Site
Seoul
1218.36.82010 Boehringer Ingelheim Investigational Site
Suwon

Other trials in South Korea

Spain10 sites

1218.36.34002 Boehringer Ingelheim Investigational Site
Badia Del Vallés (Barcelona)
1218.36.34005 Boehringer Ingelheim Investigational Site
Barcelona
1218.36.34010 Boehringer Ingelheim Investigational Site
Barcelona
1218.36.34001 Boehringer Ingelheim Investigational Site
Bercelona
1218.36.34007 Boehringer Ingelheim Investigational Site
Borges Del Camp (Tarragona)
1218.36.34003 Boehringer Ingelheim Investigational Site
Centelles (Barcelona)
1218.36.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.36.34011 Boehringer Ingelheim Investigational Site
Seville
1218.36.34009 Boehringer Ingelheim Investigational Site
Tàrrega (Lleida)
1218.36.34006 Boehringer Ingelheim Investigational Site
Vic (Barcelona)

Other trials in Spain

Taiwan10 sites

1218.36.88610 Boehringer Ingelheim Investigational Site
Changhua
1218.36.88607 Boehringer Ingelheim Investigational Site
Kaohsiung City
1218.36.88601 Boehringer Ingelheim Investigational Site
Taichung
1218.36.88603 Boehringer Ingelheim Investigational Site
Taichung
1218.36.88606 Boehringer Ingelheim Investigational Site
Tainan
1218.36.88602 Boehringer Ingelheim Investigational Site
Taipei
1218.36.88604 Boehringer Ingelheim Investigational Site
Taipei
1218.36.88605 Boehringer Ingelheim Investigational Site
Taipei
1218.36.88608 Boehringer Ingelheim Investigational Site
Taipei
1218.36.88609 Boehringer Ingelheim Investigational Site
Taipei

Other trials in Taiwan

Italy7 sites

1218.36.39002 Boehringer Ingelheim Investigational Site
Ferrara
1218.36.39003 Boehringer Ingelheim Investigational Site
Ferrara
1218.36.39004 Boehringer Ingelheim Investigational Site
Genova
1218.36.39005 Boehringer Ingelheim Investigational Site
Milan
1218.36.39001 Boehringer Ingelheim Investigational Site
Pordenone
1218.36.39007 Boehringer Ingelheim Investigational Site
Siena
1218.36.39006 Boehringer Ingelheim Investigational Site
Syracuse

Other trials in Italy

Netherlands7 sites

1218.36.31008 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1218.36.31001 Boehringer Ingelheim Investigational Site
Almere Stad
1218.36.31006 Boehringer Ingelheim Investigational Site
Beek
1218.36.31002 Boehringer Ingelheim Investigational Site
Ewijk
1218.36.31004 Boehringer Ingelheim Investigational Site
Oude Pekela
1218.36.31007 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1218.36.31005 Boehringer Ingelheim Investigational Site
Wildervank

Other trials in Netherlands

Czechia6 sites

1218.36.42006 Boehringer Ingelheim Investigational Site
Břeclav
1218.36.42004 Boehringer Ingelheim Investigational Site
Brno
1218.36.42005 Boehringer Ingelheim Investigational Site
Hodonín
1218.36.42002 Boehringer Ingelheim Investigational Site
Mladá Boleslav
1218.36.42001 Boehringer Ingelheim Investigational Site
Neratovice
1218.36.42007 Boehringer Ingelheim Investigational Site
Zlín

Other trials in Czechia

Finland6 sites

1218.36.35807 Boehringer Ingelheim Investigational Site
Joensuu
1218.36.35802 Boehringer Ingelheim Investigational Site
Kuopio
1218.36.35803 Boehringer Ingelheim Investigational Site
Oulu
1218.36.35805 Boehringer Ingelheim Investigational Site
Tampere
1218.36.35804 Boehringer Ingelheim Investigational Site
Turku
1218.36.35806 Boehringer Ingelheim Investigational Site
Vantaa

Other trials in Finland

Greece6 sites

1218.36.30003 Boehringer Ingelheim Investigational Site
Athens
1218.36.30007 Boehringer Ingelheim Investigational Site
Athens
1218.36.30010 Boehringer Ingelheim Investigational Site
Athens
1218.36.30011 Boehringer Ingelheim Investigational Site
Larissa
1218.36.30002 Boehringer Ingelheim Investigational Site
Nikaia
1218.36.30005 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Russia6 sites

1218.36.70002 Boehringer Ingelheim Investigational Site
Moscow
1218.36.70003 Boehringer Ingelheim Investigational Site
Moscow
1218.36.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.36.70001 Boehringer Ingelheim Investigational Site
Samara
1218.36.70007 Boehringer Ingelheim Investigational Site
Smolensk
1218.36.70006 Boehringer Ingelheim Investigational Site
Yaroslavl

Other trials in Russia

Slovakia6 sites

1218.36.42103 Boehringer Ingelheim Investigational Site
Banská Bystrica
1218.36.42101 Boehringer Ingelheim Investigational Site
Bratislava
1218.36.42102 Boehringer Ingelheim Investigational Site
Bratislava
1218.36.42104 Boehringer Ingelheim Investigational Site
Bratislava
1218.36.42105 Boehringer Ingelheim Investigational Site
Prešov
1218.36.42106 Boehringer Ingelheim Investigational Site
Trebišov

Other trials in Slovakia

Argentina5 sites

1218.36.54001 Boehringer Ingelheim Investigational Site
Capital Federal
1218.36.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1218.36.54003 Boehringer Ingelheim Investigational Site
Capital Federal
1218.36.54005 Boehringer Ingelheim Investigational Site
Capital Federal
1218.36.54004 Boehringer Ingelheim Investigational Site
Córdoba

Other trials in Argentina

Norway5 sites

1218.36.47002 Boehringer Ingelheim Investigational Site
Bergen
1218.36.47006 Boehringer Ingelheim Investigational Site
Elverum
1218.36.47005 Boehringer Ingelheim Investigational Site
Hamar
1218.36.47004 Boehringer Ingelheim Investigational Site
Oslo
1218.36.47001 Boehringer Ingelheim Investigational Site
Stavanger

Other trials in Norway

Brazil4 sites

1218.36.55003 Boehringer Ingelheim Investigational Site
Belém
1218.36.55004 Boehringer Ingelheim Investigational Site
Porto Alegre
1218.36.55001 Boehringer Ingelheim Investigational Site
São Paulo
1218.36.55002 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Belgium3 sites

1218.36.32002 Boehringer Ingelheim Investigational Site
Edegem
1218.36.320099 Boehringer Ingelheim Investigational Site
Edegem
1218.36.32006 Boehringer Ingelheim Investigational Site
Sint-Gillis-Waas

Other trials in Belgium

Mexico3 sites

1218.36.52002 Boehringer Ingelheim Investigational Site
Pachuca
1218.36.52004 Boehringer Ingelheim Investigational Site
San Luis Potosí City
1218.36.52005 Boehringer Ingelheim Investigational Site
Tijuana

Other trials in Mexico

Peru1 site

1218.36.51003 Boehringer Ingelheim Investigational Site
Lima

Other trials in Peru

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 for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, Linagliptin
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.

PlaceboDrug
Placebo, identical to Linagliptin tablet
LinagliptinDrug
intended final marketed dose

Study groups in NCT00954447
Study group	Role	What they receive
Linagliptin	Experimental	patient receives a tablet with intended final marketed dose Receives: Drug: Linagliptin
Placebo	Placebo comparator	patient receives a tablet identical to those containing Linagliptin Receives: Drug: Placebo

What is being measured

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

Change From Baseline in HbA1c After 24 Weeks
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Measured: Baseline and 24 weeks

Secondary outcomes (14)

Number of Patients With HbA1c < 7.0 Percent
Measured: 24 and 52 weeks
Number of Patients Lowering HbA1c by at Least 0.5 Percent
Measured: 24 and 52 weeks
Change From Baseline in HbA1c by Visit at Week 6
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 6 weeks
Change From Baseline in HbA1c by Visit at Week 12
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 12 weeks
Change From Baseline in HbA1c by Visit at Week 18
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 18 weeks
Change From Baseline in HbA1c by Visit at Week 32
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 32 weeks
Change From Baseline in HbA1c by Visit at Week 40
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 40 weeks
Change From Baseline in HbA1c by Visit at Week 52
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Measured: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Measured: Baseline and 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Measured: Baseline and 52 weeks
Change From Baseline in FPG
Measured: Baseline, 6, 12, 18, 24, 32 and 40 weeks
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Measured: Baseline and 52 weeks
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
Mean Daily Glucose was calculated using the 8-point blood glucose profile
Measured: Baseline, 24 and 52 weeks
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
Measured: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner

Timeline

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

Aug 2009Sep 2011

First posted7 Aug 2009 (estimated)
Study startAug 2009
Primary completionSep 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 (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: 1,263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00954447
Sponsor's protocol ID: 1218.36
Other IDs: 2008-008296-33, 2008
Status last verified: Oct 2012
First submitted: 6 Aug 2009
Last updated: 30 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Sheu WH, Park SW, Gong Y, Pinnetti S, Bhattacharya S, Patel S, Seck T, Woerle HJ. Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.
PubMed 25629790
Yki-Jarvinen H, Rosenstock J, Duran-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a >/=52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.
PubMed 24062327

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 30 Dec 2013. 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 for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
ClinicalTrials.gov ID: NCT00954447
Acronym / sponsor ID: 1218.36
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,263 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Aug 2009
Primary completion: Sep 2011 (actual)
First posted: 7 Aug 2009 (estimated)
Results: Posted 27 Sep 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: Linagliptinpatient receives a tablet with intended final marketed dose
Placebo	Placebo comparator	Drug: Placebopatient receives a tablet identical to those containing Linagliptin

Who may qualify

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

Key inclusion criteria (2 listed)

Diabetes type 2, detectable C-peptide, HbA1c 7-10%
Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Key exclusion criteria (5 listed)

Uncontrolled hyperglycemia during Run-in
Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Liver impairment; gastric surgery; medical history of cancer in last 5 years
Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
Unsufficient birth control, pregnancy and nursing

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
PlaceboPlacebo, identical to Linagliptin tablet	Drug	Placebo
Linagliptinintended final marketed dose	Drug	Linagliptin

Primary outcome

Change From Baseline in HbA1c After 24 Weeks
Time frame: Baseline and 24 weeks
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

14 secondary outcomes

Number of Patients With HbA1c < 7.0 Percent
Time frame: 24 and 52 weeks
Number of Patients Lowering HbA1c by at Least 0.5 Percent
Time frame: 24 and 52 weeks
Change From Baseline in HbA1c by Visit at Week 6
Time frame: Baseline and 6 weeks
Change From Baseline in HbA1c by Visit at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in HbA1c by Visit at Week 18
Time frame: Baseline and 18 weeks
Change From Baseline in HbA1c by Visit at Week 32
Time frame: Baseline and 32 weeks
Change From Baseline in HbA1c by Visit at Week 40
Time frame: Baseline and 40 weeks
Change From Baseline in HbA1c by Visit at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change From Baseline in FPG
Time frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
Time frame: Baseline, 24 and 52 weeks
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner

Results and safety

Results posted to the registry on 27 Sep 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	630	520
Linagliptin 5 mg	631	543

Primary outcome: Change From Baseline in HbA1c After 24 Weeks

Time frame: Baseline and 24 weeks. Mean (Standard Error). Unit: Percentage

Measure	Placebo n = 617	Linagliptin 5 mg n = 618
Value	0.07 (0.08)	-0.58 (0.08)

Placebo vs Linagliptin 5 mg: Mean Difference (Final Values): -0.65 (95% CI -0.74 to -0.55), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	83 of 630 (13.2%)	354 of 630 (56.2%)	Not reported
Linagliptin 5 mg	87 of 631 (13.8%)	354 of 631 (56.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25629790Sheu WH, Park SW, Gong Y, Pinnetti S, Bhattacharya S, Patel S, Seck T, Woerle HJ. Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.
Derived from this study: PubMed 24062327Yki-Jarvinen H, Rosenstock J, Duran-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a >/=52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.

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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

169 sites in 19 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 169 sites in 19 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 5 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 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Germany, Canada, South Korea, Spain and 14 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 27 Sep 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?

Change From Baseline in HbA1c After 24 Weeks (time frame: Baseline and 24 weeks). 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 NCT00954447, 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 30 Dec 2013.