Diabetes Mellitus, Type 2Phase 3NCT00601250

Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 82 sites in 10 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 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 701 participants
Where: 82 sitesin 10 countries
Study dates: Jan 2008to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
Age 18 -80 years
BMI (Body Mass Index) less than 40 kg/m2
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Who cannot join

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent

Show all 17Show fewer

Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent
Pre-menopausal women 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.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance

Trial locations and contacts

82 sites in 10 countries.

Country

City, postcode or hospital

82 sites in 10 countries

United States19 sites

1218.17.10012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1218.17.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.17.10005 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.17.10016 Boehringer Ingelheim Investigational Site
Eugene, Oregon
1218.17.10009 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1218.17.10002 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.17.10017 Boehringer Ingelheim Investigational Site
Gurnee, Illinois
1218.17.10010 Boehringer Ingelheim Investigational Site
Hollywood, Florida
1218.17.10018 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.17.10013 Boehringer Ingelheim Investigational Site
Mentor, Ohio
1218.17.10011 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.17.10021 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1218.17.10015 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1218.17.10006 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1218.17.10008 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1218.17.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.17.10004 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1218.17.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California
1218.17.10001 Boehringer Ingelheim Investigational Site
Walnut Creek, California

Other trials in United States

India14 sites

1218.17.91009 Boehringer Ingelheim Investigational Site
Andhra Pradesh
1218.17.91002 Boehringer Ingelheim Investigational Site
Bangalore
1218.17.91005 Boehringer Ingelheim Investigational Site
Bangalore
1218.17.91012 Boehringer Ingelheim Investigational Site
Chennai
1218.17.91014 Boehringer Ingelheim Investigational Site
Chennai
1218.17.91010 Boehringer Ingelheim Investigational Site
Hyderabad
1218.17.91006 Boehringer Ingelheim Investigational Site
Jaipur
1218.17.91007 Boehringer Ingelheim Investigational Site
Karnataka
1218.17.91008 Boehringer Ingelheim Investigational Site
Mangalore
1218.17.91004 Boehringer Ingelheim Investigational Site
Mumbai
1218.17.91011 Boehringer Ingelheim Investigational Site
Nagpur
1218.17.91003 Boehringer Ingelheim Investigational Site
Nashik
1218.17.91001 Boehringer Ingelheim Investigational Site
Trivandrum
1218.17.91013 Boehringer Ingelheim Investigational Site
Uttar Pradesh

Other trials in India

Mexico10 sites

1218.17.52007 Boehringer Ingelheim Investigational Site
Aguascalientes, Ags.
1218.17.52009 Boehringer Ingelheim Investigational Site
cOL OBREGON,León, Guanajuato
1218.17.52003 Boehringer Ingelheim Investigational Site
Col. Lomas de San Francisco, Monterrey
1218.17.52001 Boehringer Ingelheim Investigational Site
Col. Mitras Centro, Monterrey, N.L.
1218.17.52010 Boehringer Ingelheim Investigational Site
Col.Americana, Guadalajara, Jalisco
1218.17.52008 Boehringer Ingelheim Investigational Site
Colonia Tlalpan, Mexico
1218.17.52006 Boehringer Ingelheim Investigational Site
Faccionamiento Lomas de Campestre,AGUASCAL
1218.17.52005 Boehringer Ingelheim Investigational Site
Lomas de Reforma
1218.17.52002 Boehringer Ingelheim Investigational Site
México
1218.17.52004 Boehringer Ingelheim Investigational Site
Tlalpan-México D,F

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Czechia7 sites

1218.17.42006 Boehringer Ingelheim Investigational Site
Břeclav
1218.17.42001 Boehringer Ingelheim Investigational Site
Brno
1218.17.42004 Boehringer Ingelheim Investigational Site
Brno
1218.17.42007 Boehringer Ingelheim Investigational Site
Brno
1218.17.42009 Boehringer Ingelheim Investigational Site
Brno
1218.17.42008 Boehringer Ingelheim Investigational Site
Hodonín
1218.17.42003 Boehringer Ingelheim Investigational Site
Olomouc

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Israel7 sites

1218.17.97274 Boehringer Ingelheim Investigational Site
Afula
1218.17.97273 Boehringer Ingelheim Investigational Site
Haifa
1218.17.97275 Boehringer Ingelheim Investigational Site
Holon
1218.17.97271 Boehringer Ingelheim Investigational Site
Jerusalem
1218.17.97272 Boehringer Ingelheim Investigational Site
Nahariya
1218.17.97276 Boehringer Ingelheim Investigational Site
Safed
1218.17.97278 Boehringer Ingelheim Investigational Site
Tel Aviv

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Finland6 sites

1218.17.35806 Boehringer Ingelheim Investigational Site
Helsinki
1218.17.35804 Boehringer Ingelheim Investigational Site
Jyväskylä
1218.17.35801 Boehringer Ingelheim Investigational Site
Kuopio
1218.17.35803 Boehringer Ingelheim Investigational Site
Oulu
1218.17.35805 Boehringer Ingelheim Investigational Site
Seinäjoki
1218.17.35802 Boehringer Ingelheim Investigational Site
Turku

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Russia6 sites

1218.17.70001 Boehringer Ingelheim Investigational Site
Moscow
1218.17.70002 Boehringer Ingelheim Investigational Site
Moscow
1218.17.70003 Boehringer Ingelheim Investigational Site
Moscow
1218.17.70005 Boehringer Ingelheim Investigational Site
Novosibirsk
1218.17.70006 Boehringer Ingelheim Investigational Site
Perm
1218.17.70004 Boehringer Ingelheim Investigational Site
Tomsk

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New Zealand5 sites

1218.17.64004 Boehringer Ingelheim Investigational Site
Christchurch
1218.17.64003 Boehringer Ingelheim Investigational Site
Dunedin
1218.17.64002 Boehringer Ingelheim Investigational Site
Otahuhu
1218.17.64001 Boehringer Ingelheim Investigational Site
Tauranga
1218.17.64005 Boehringer Ingelheim Investigational Site
Wellington

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Sweden5 sites

1218.17.46013 Boehringer Ingelheim Investigational Site
Härnösand
1218.17.46001 Boehringer Ingelheim Investigational Site
Malmö
1218.17.46012 Boehringer Ingelheim Investigational Site
Uddevalla
1218.17.46004 Boehringer Ingelheim Investigational Site
Uppsala
1218.17.46015 Boehringer Ingelheim Investigational Site
Uppsala

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Greece3 sites

1218.17.30004 Boehringer Ingelheim Investigational Site
Athens
1218.17.30013 Boehringer Ingelheim Investigational Site
Athens
1218.17.30011 Boehringer Ingelheim Investigational Site
Piraeus

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About this study

Official title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Conditions: Diabetes Mellitus, Type 2
Being tested: 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.

linagliptinDrug
Patients receive linagliptin 5 mg tablets once daily
linagliptinDrug
Patients receive linagliptin 5 mg tablets once daily

Study groups in NCT00601250
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 tablets once daily Receives: Drug: linagliptin

What is being measured

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

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

Secondary outcomes (14)

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

Timeline

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

Jan 2008May 2009

First posted28 Jan 2008 (estimated)
Study startJan 2008
Primary completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (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: 701 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00601250
Sponsor's protocol ID: 1218.17
Other IDs: 2007-002457-24
Status last verified: Dec 2013
First submitted: 15 Jan 2008
Last updated: 28 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
PubMed 27484756

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

Official title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
ClinicalTrials.gov ID: NCT00601250
Acronym / sponsor ID: 1218.17
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 701 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: May 2009 (actual)
First posted: 28 Jan 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
Linagliptin	Experimental	Drug: linagliptinPatients receive linagliptin 5 mg tablets once daily
Placebo	Placebo comparator	Drug: linagliptinPatients receive placebo tablets matching linagliptin 5 mg tablets once daily

Who may qualify

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

Key inclusion criteria (8 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in

Key exclusion criteria (17 listed)

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
linagliptinPatients receive linagliptin 5 mg tablets once daily	Drug	Placebo
linagliptinPatients receive linagliptin 5 mg tablets once daily	Drug	Linagliptin

Primary outcome

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

14 secondary outcomes

HbA1c Change From Baseline at Week 6
Time frame: Baseline and week 6
HbA1c Change From Baseline at Week 12
Time frame: Baseline and week 12
HbA1c Change From Baseline at Week 18
Time frame: Baseline and week 18
FPG Change From Baseline at Week 24
Time frame: Baseline and week 24
FPG Change From Baseline at Week 6
Time frame: Baseline and week 6
FPG Change From Baseline at Week 12
Time frame: Baseline and week 12
FPG Change From Baseline at Week 18
Time frame: Baseline and week 18
Percentage of Patients With HbA1c <7.0% at Week 24.
Time frame: Baseline and week 24
Percentage of Patients With HbA1c < 7.0% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c<6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
Time frame: Baseline and week 24
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
Time frame: Baseline and week 24
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) 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	177	163
Linagliptin	523	484

Primary outcome: HbA1c Change From Baseline at Week 24

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

Measure	Placebo n = 175	Linagliptin n = 513
Value	0.15 (0.06)	-0.49 (0.04)

Placebo vs Linagliptin: Least Squares Mean Difference: -0.64 (95% CI -0.78 to -0.5), 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.

14 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 177 (2.3%)	34 of 177 (19.2%)	Not reported
Linagliptin	18 of 523 (3.4%)	54 of 523 (10.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27484756Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
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

82 sites in 10 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 82 sites in 10 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 8 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 28 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 82 sites in United States, India, Mexico, Czechia, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Change From Baseline at Week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00601250, 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 28 Jan 2014.