Diabetes Mellitus, Type 2Phase 3NCT01215097

Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

A Phase 3 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 19 sites in 3 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

In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 306 participants
Where: 19 sitesin 3 countries
Study dates: Oct 2010to Apr 2012
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 (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
Age = 18 and < 80 years at Visit 1a (Screening)
BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
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 TIA within 6 months prior to informed consent
Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
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 Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent

Show all 19Show fewer

Treatment with insulin within 3 months prior to informed consent
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 (last menstruation =1 year prior to informed consent) 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. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
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 (serum creatinine =1.5 mg/dl as determined at Visit 1a)
Dehydration by clinical judgement of the investigator
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

China15 sites

1218.65.86007 Boehringer Ingelheim Investigational Site
Beijing
1218.65.86011 Boehringer Ingelheim Investigational Site
Chongqing
1218.65.86008 Boehringer Ingelheim Investigational Site
Dalian
1218.65.86010 Boehringer Ingelheim Investigational Site
Fuzhou
1218.65.86014 Boehringer Ingelheim Investigational Site
Hangzhou
1218.65.86005 Boehringer Ingelheim Investigational Site
Hefei
1218.65.86006 Boehringer Ingelheim Investigational Site
Hefei
1218.65.86012 Boehringer Ingelheim Investigational Site
Nanjing
1218.65.86001 Boehringer Ingelheim Investigational Site
Shanghai
1218.65.86002 Boehringer Ingelheim Investigational Site
Shanghai
1218.65.86003 Boehringer Ingelheim Investigational Site
Shanghai
1218.65.86004 Boehringer Ingelheim Investigational Site
Suzhou
1218.65.86015 Boehringer Ingelheim Investigational Site
Wenzhou
1218.65.86009 Boehringer Ingelheim Investigational Site
Wuhan
1218.65.86013 Boehringer Ingelheim Investigational Site
Yangzhou

Other trials in China

Malaysia2 sites

1218.65.60002 Boehringer Ingelheim Investigational Site
Johor Bahru
1218.65.60001 Boehringer Ingelheim Investigational Site
Kelantan

Other trials in Malaysia

Philippines2 sites

1218.65.63001 Boehringer Ingelheim Investigational Site
Marikina City
1218.65.63002 Boehringer Ingelheim Investigational Site
San Juan City

Other trials in Philippines

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin 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
once a day
placeboDrug
once a day

Study groups in NCT01215097
Study group	Role	What they receive
Linagliptin	Experimental	once a day Receives: Drug: Linagliptin
placebo	Placebo comparator	once a day Receives: Drug: placebo

What is being measured

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

HbA1c Change From Baseline at Week 24
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and at week 24

Secondary outcomes (13)

HbA1c Change From Baseline at Week 6
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and at week 6
HbA1c Change From Baseline at Week 12
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and at week 12
HbA1c Change From Baseline at Week 18
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and at week 18
HbA1c Change From Baseline at Week 24(Chinese Only)
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and at 24 weeks
FPG Change From Baseline at Week 24
Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.
Measured: Baseline and at week 24
FPG Change From Baseline at Week 6
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Measured: Baseline and at week 6
FPG Change From Baseline at Week 12
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Measured: Baseline and at week 12
FPG Change From Baseline at Week 18
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Measured: Baseline and at week 18
Number of Patients With HbA1c < 7.0%
Number of patients with HbA1c < 7.0% at week 24
Measured: baseline and at week 24
Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.
Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.
Measured: baseline and at week 24
Number of Patients With HbA1c < 6.5%
Number of patients with HbA1c < 6.5% at week 24
Measured: baseline and at week 24
Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.
Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.
Measured: baseline and at week 24
Number With HbA1c at Least Lowering 0.5%
Number with HbA1c at least 0.5% lowering from baseline at week 24
Measured: baseline and at week 24

Timeline

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

Oct 2010Apr 2012

First posted6 Oct 2010 (estimated)
Study startOct 2010
Primary completionApr 2012
Study completionApr 2012

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215097
Sponsor's protocol ID: 1218.65
Status last verified: Jul 2016
First submitted: 28 Sep 2010
Last updated: 25 Aug 2016
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?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin Therapy
ClinicalTrials.gov ID: NCT01215097
Acronym / sponsor ID: 1218.65
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Oct 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 3 Jun 2013

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: Linagliptinonce a day
placebo	Placebo comparator	Drug: placeboonce a day

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 (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)

Key exclusion criteria (19 listed)

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
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

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
Linagliptinonce a day	Drug	Linagliptin
placeboonce a day	Drug	placebo

Primary outcome

HbA1c Change From Baseline at Week 24
Time frame: Baseline and at week 24
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

13 secondary outcomes

HbA1c Change From Baseline at Week 6
Time frame: Baseline and at week 6
HbA1c Change From Baseline at Week 12
Time frame: Baseline and at week 12
HbA1c Change From Baseline at Week 18
Time frame: Baseline and at week 18
HbA1c Change From Baseline at Week 24(Chinese Only)
Time frame: Baseline and at 24 weeks
FPG Change From Baseline at Week 24
Time frame: Baseline and at week 24
FPG Change From Baseline at Week 6
Time frame: Baseline and at week 6
FPG Change From Baseline at Week 12
Time frame: Baseline and at week 12
FPG Change From Baseline at Week 18
Time frame: Baseline and at week 18
Number of Patients With HbA1c < 7.0%
Time frame: baseline and at week 24
Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.
Time frame: baseline and at week 24
Number of Patients With HbA1c < 6.5%
Time frame: baseline and at week 24
Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.
Time frame: baseline and at week 24
Number With HbA1c at Least Lowering 0.5%
Time frame: baseline and at week 24

Results and safety

Results posted to the registry on 3 Jun 2013, 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	100	88
Linagliptin 5mg	205	191

Primary outcome: HbA1c Change From Baseline at Week 24

Time frame: Baseline and at week 24. Least squares mean (Standard Error). Unit: Percent

Measure	Placebo n = 97	Linagliptin 5mg n = 203
Value	-0.14 (0.07)	-0.66 (0.05)

Placebo vs Linagliptin 5mg: Adjusted mean difference: -0.52 (95% CI -0.70 to -0.34), 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.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 100 (2%)	13 of 100 (13%)	Not reported
Linagliptin 5mg	4 of 205 (2%)	29 of 205 (14.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

19 sites in 3 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 19 sites in 3 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 19 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China, Malaysia, Philippines. 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 3 Jun 2013). 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 at 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 NCT01215097.

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 25 Aug 2016.