Diabetes Mellitus, Type 2Phase 2NCT00328172

Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

A Phase 2 study testing BI 1356 dose 3 once daily, BI 1356 dose 2 once daily and BI 1356 dose 1 once daily in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 71 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?: BI 1356 dose 3 once daily, BI 1356 dose 2 once daily and BI 1356 dose 1 once daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 71 sitesin 6 countries
Study dates: May 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

Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
Diagnosis of Type 2 diabetes with duration of at least 3 months
Glycosylated haemoglobin A1 (HbA1c) of:
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
Age >=21 and <=75 years.
BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)

Show all 16Show fewer

Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening
Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
are not surgically sterile,
or are nursing or pregnant;
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
Intolerance of metformin

Trial locations and contacts

71 sites in 6 countries.

Country

City, postcode or hospital

71 sites in 6 countries

United States34 sites

1218.5.10042 Boehringer Ingelheim Investigational Site
Albany, New York
1218.5.10039 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1218.5.10034 Boehringer Ingelheim Investigational Site
Butte, Montana
1218.5.10025 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
1218.5.10020 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.5.10044 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1218.5.10026 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1218.5.10006 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.5.10041 Boehringer Ingelheim Investigational Site
Denver, Colorado
1218.5.10029 Boehringer Ingelheim Investigational Site
Endwell, New York
1218.5.10022 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1218.5.10033 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.5.10018 Boehringer Ingelheim Investigational Site
Hollywood, Florida
1218.5.10040 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.5.10017 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1218.5.10016 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1218.5.10001 Boehringer Ingelheim Investigational Site
La Jolla, California
1218.5.10023 Boehringer Ingelheim Investigational Site
Medford, Oregon
1218.5.10035 Boehringer Ingelheim Investigational Site
Mentor, Ohio
1218.5.10003 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.5.10011 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.5.10004 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1218.5.10009 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1218.5.10012 Boehringer Ingelheim Investigational Site
Orlando, Florida
1218.5.10030 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.5.10014 Boehringer Ingelheim Investigational Site
Renton, Washington
1218.5.10027 Boehringer Ingelheim Investigational Site
Salem, Virginia
1218.5.10036 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.5.10038 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1218.5.10032 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1218.5.10008 Boehringer Ingelheim Investigational Site
Topeka, Kansas
1218.5.10021 Boehringer Ingelheim Investigational Site
Tyler, Texas
1218.5.10007 Boehringer Ingelheim Investigational Site
Walnut Creek, California
1218.5.10024 Boehringer Ingelheim Investigational Site
Wichita, Kansas

Other trials in United States

Canada15 sites

1218.5.11011 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.5.11016 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.5.11005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.5.11006 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island
1218.5.11014 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1218.5.11010 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1218.5.11003 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1218.5.11017 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec
1218.5.11009 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.5.11018 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1218.5.11012 Boehringer Ingelheim Investigational Site
Thornhill, Ontario
1218.5.11002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.5.11004 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.5.11013 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.5.11015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Australia6 sites

1218.5.61005 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1218.5.61006 Boehringer Ingelheim Investigational Site
Dandenong, Victoria
1218.5.61007 Boehringer Ingelheim Investigational Site
East Ringwood, Victoria
1218.5.61004 Boehringer Ingelheim Investigational Site
Fremantle, Western Australia
1218.5.61001 Boehringer Ingelheim Investigational Site
Miranda, New South Wales
1218.5.61002 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia

Other trials in Australia

Ukraine6 sites

1218.5.38005 Boehringer Ingelheim Investigational Site
Kharkiv
1218.5.38001 Boehringer Ingelheim Investigational Site
Kiev
1218.5.38002 Boehringer Ingelheim Investigational Site
Kiev
1218.5.38003 Boehringer Ingelheim Investigational Site
Kiev
1218.5.38004 Boehringer Ingelheim Investigational Site
Lviv
1218.5.38006 Boehringer Ingelheim Investigational Site
Vinnitsa

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Czechia5 sites

1218.5.42002 Boehringer Ingelheim Investigational Site
Olomouc
1218.5.42003 Boehringer Ingelheim Investigational Site
Prague
1218.5.42004 Boehringer Ingelheim Investigational Site
Prague
1218.5.42005 Boehringer Ingelheim Investigational Site
Prague
1218.5.42001 Boehringer Ingelheim Investigational Site
Sternberk

Other trials in Czechia

Russia5 sites

1218.5.70001 Boehringer Ingelheim Investigational Site
Moscow
1218.5.70002 Boehringer Ingelheim Investigational Site
Moscow
1218.5.70003 Boehringer Ingelheim Investigational Site
Moscow
1218.5.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.5.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, BI 1356 dose 3 once daily, BI 1356 dose 2 once daily, BI 1356 dose 1 once daily, Metformin
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 matching BI 1356
BI 1356 dose 3 once dailyDrug
BI 1356 dose 3 once daily
BI 1356 dose 2 once dailyDrug
BI 1356 dose 2 once daily
BI 1356 dose 1 once dailyDrug
BI 1356 dose 1 once daily
MetforminDrug
Metformin

Study groups in NCT00328172
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo tablets matching BI 1356 Receives: Drug: Placebo
BI 1356 0.5 mg	Experimental	BI 1356 dose 1 once daily Receives: Drug: BI 1356 dose 1 once daily
BI 1356 2.5 mg	Experimental	BI 1356 dose 2 once daily Receives: Drug: BI 1356 dose 2 once daily
BI 1356 5.0 mg	Experimental	BI 1356 dose 3 once daily Receives: Drug: BI 1356 dose 3 once daily
Metformin	Active comparator	Metformin Receives: Drug: Metformin

What is being measured

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

Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.
Measured: Baseline, week 12

Secondary outcomes (2)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.
Measured: Baseline, week 12
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks
An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.
Measured: Baseline, week 12

Timeline

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

May 2006Aug 2007

First posted19 May 2006 (estimated)
Study startMay 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: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00328172
Sponsor's protocol ID: 1218.5
Status last verified: Feb 2014
First submitted: 18 May 2006
Last updated: 14 Mar 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 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
ClinicalTrials.gov ID: NCT00328172
Acronym / sponsor ID: 1218.5
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Aug 2007 (actual)
First posted: 19 May 2006 (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: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 1356
BI 1356 0.5 mg	Experimental	Drug: BI 1356 dose 1 once dailyBI 1356 dose 1 once daily
BI 1356 2.5 mg	Experimental	Drug: BI 1356 dose 2 once dailyBI 1356 dose 2 once daily
BI 1356 5.0 mg	Experimental	Drug: BI 1356 dose 3 once dailyBI 1356 dose 3 once daily
Metformin	Active comparator	Drug: MetforminMetformin

Who may qualify

Ages: 21 to 75 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 treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
Diagnosis of Type 2 diabetes with duration of at least 3 months
Glycosylated haemoglobin A1 (HbA1c) of:
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).

Key exclusion criteria (16 listed)

Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)

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 matching BI 1356	Drug	Placebo
BI 1356 dose 3 once dailyBI 1356 dose 3 once daily	Drug	BI 1356 5.0 mg
BI 1356 dose 2 once dailyBI 1356 dose 2 once daily	Drug	BI 1356 2.5 mg
BI 1356 dose 1 once dailyBI 1356 dose 1 once daily	Drug	BI 1356 0.5 mg
MetforminMetformin	Drug	Metformin

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
Time frame: Baseline, week 12
The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.

2 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline, week 12
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks
Time frame: Baseline, week 12

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	67	45
Linagliptin (BI 1356) 0.5 mg	58	44
Linagliptin (BI 1356) 2.5 mg	57	47
Linagliptin (BI 1356) 5.0 mg	55	42
Metformin	65	60

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12

Time frame: Baseline, week 12. Least squares mean (Standard Error). Unit: percent

Measure	Placebo n = 63	Linagliptin (BI 1356) 0.5 mg n = 57	Linagliptin (BI 1356) 2.5 mg n = 55	Linagliptin (BI 1356) 5.0 mg n = 54	Metformin n = 65
Value	0.18 (0.10)	0.04 (0.10)	-0.24 (0.10)	-0.28 (0.10)	-0.68 (0.09)

Placebo vs Linagliptin (BI 1356) 0.5 mg: Mean Difference (Final Values): -0.14 (95% CI -0.41 to 0.14), p = 0.3271, ANCOVA
Placebo vs Linagliptin (BI 1356) 2.5 mg: Mean Difference (Final Values): -0.42 (95% CI -0.69 to -0.14), p = 0.0032, ANCOVA
Placebo vs Linagliptin (BI 1356) 5.0 mg: Mean Difference (Final Values): -0.46 (95% CI -0.74 to -0.18), p = 0.0012, ANCOVA

Population analysed: Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study medication up to a period of 30 days after the last dose of study medication, an average of 106 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 67 (1.5%)	18 of 67 (26.9%)	Not reported
Linagliptin (BI 1356) 0.5 mg	1 of 58 (1.7%)	15 of 58 (25.9%)	Not reported
Linagliptin (BI 1356) 2.5 mg	2 of 57 (3.5%)	9 of 57 (15.8%)	Not reported
Linagliptin (BI 1356) 5.0 mg	0 of 55 (0%)	8 of 55 (14.5%)	Not reported
Metformin	1 of 65 (1.5%)	13 of 65 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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

Questions about this trial

What is this clinical trial studying?

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 16 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada, Australia, Ukraine, Czechia 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 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?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12 (time frame: Baseline, 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 NCT00328172.

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 14 Mar 2014.