Diabetes Mellitus, Type 2Phase 2NCT01342484

Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

A Phase 2 study testing BI1356 low dose and BI1356 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 25 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI1356 low dose and BI1356 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 25 sitesin 9 countries
Study dates: Apr 2011to Feb 2016
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 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
Insufficient glycaemic control (i.e. an HbA1c > 6.5% and <= 10.5%) despite treatment with diet and exercise and/or metformin (>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be <= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge)

Who cannot join

History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
Treatment with weight reduction medications (including anti-obesity treatments)

Trial locations and contacts

25 sites in 9 countries.

Country

City, postcode or hospital

25 sites in 9 countries

Mexico5 sites

1218.56.52008 Boehringer Ingelheim Investigational Site
Chihuahua City
1218.56.52002 Boehringer Ingelheim Investigational Site
Guadalajara
1218.56.52001 Boehringer Ingelheim Investigational Site
León
1218.56.52003 Boehringer Ingelheim Investigational Site
Monterrey
1218.56.52004 Boehringer Ingelheim Investigational Site
Oaxaca City

Other trials in Mexico

Poland4 sites

1218.56.48002 Boehringer Ingelheim Investigational Site
Gdansk
1218.56.48001 Boehringer Ingelheim Investigational Site
Gliwice
1218.56.48004 Boehringer Ingelheim Investigational Site
Warsaw
1218.56.48003 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Russia4 sites

1218.56.70001 Boehringer Ingelheim Investigational Site
Moscow
1218.56.70003 Boehringer Ingelheim Investigational Site
Saratov
1218.56.70004 Boehringer Ingelheim Investigational Site
Ufa
1218.56.70006 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

South Korea4 sites

1218.56.82005 Boehringer Ingelheim Investigational Site
Busan
1218.56.82001 Boehringer Ingelheim Investigational Site
Seoul
1218.56.82002 Boehringer Ingelheim Investigational Site
Seoul
1218.56.82003 Boehringer Ingelheim Investigational Site
Suwon

Other trials in South Korea

United States2 sites

1218.56.01004 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1218.56.01006 Boehringer Ingelheim Investigational Site
San Antonio, Texas

Other trials in United States

France2 sites

1218.56.33003 Boehringer Ingelheim Investigational Site
Fort de France Cedex
1218.56.33006 Boehringer Ingelheim Investigational Site
Rouen

Other trials in France

Guatemala2 sites

1218.56.50202 Boehringer Ingelheim Investigational Site
Guatemala City
1218.56.50203 Boehringer Ingelheim Investigational Site
Guatemala City

Other trials in Guatemala

Canada1 site

1218.56.11001 Boehringer Ingelheim Investigational Site
Montreal, Quebec

Other trials in Canada

Italy1 site

1218.56.39005 Boehringer Ingelheim Investigational Site
Florence

Other trials in Italy

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus

The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

Conditions: Diabetes Mellitus, Type 2
Being tested: placebo, BI1356 low dose, BI1356 high dose
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
comparison of different dosages of drug (low vs high) vs placebo
BI1356 low doseDrug
comparison of different dosages of drug (low vs high) vs placebo
BI1356 high doseDrug
comparison of different dosages of drug (low vs high) vs placebo

Study groups in NCT01342484
Study group	Role	What they receive
linagliptin low dose	Experimental	linagliptin low dose for children once daily Receives: Drug: BI1356 low dose
linagliptin high dose	Experimental	linagliptin high dose for children once daily Receives: Drug: BI1356 high dose
placebo	Placebo comparator	matching placebo for each linagliptin dose once daily Receives: Drug: placebo

What is being measured

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

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Measured: Baseline and 12 weeks

Secondary outcomes (2)

Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State
DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.
Measured: Baseline and 4 weeks or 8 weeks or 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Measured: Baseline and 12 weeks

Timeline

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

Apr 2011Feb 2016

First posted27 Apr 2011 (estimated)
Study startApr 2011
Primary completionFeb 2016
Study completionFeb 2016

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01342484
Sponsor's protocol ID: 1218.56
Other IDs: 2009-017004-91, 2009
Status last verified: Jul 2016
First submitted: 26 Apr 2011
Last updated: 15 Sep 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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01342484
Acronym / sponsor ID: 1218.56
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Apr 2011
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 27 Apr 2011 (estimated)
Results: Posted 15 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
linagliptin low dose	Experimental	Drug: BI1356 low doselinagliptin low dose for children once daily
linagliptin high dose	Experimental	Drug: BI1356 high doselinagliptin high dose for children once daily
placebo	Placebo comparator	Drug: placebomatching placebo for each linagliptin dose once daily

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
Insufficient glycaemic control (i.e. an HbA1c > 6.5% and <= 10.5%) despite treatment with diet and exercise and/or metformin (>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be <= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge)

Key exclusion criteria (3 listed)

History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
Treatment with weight reduction medications (including anti-obesity treatments)

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
placebocomparison of different dosages of drug (low vs high) vs placebo	Drug	placebo
BI1356 low dosecomparison of different dosages of drug (low vs high) vs placebo	Drug	linagliptin low dose
BI1356 high dosecomparison of different dosages of drug (low vs high) vs placebo	Drug	linagliptin high dose

Primary outcome

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.

2 secondary outcomes

Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State
Time frame: Baseline and 4 weeks or 8 weeks or 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 15 Sep 2016, 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	15	13
Linagliptin 1 mg	10	10
Linagliptin 5 mg	14	13

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: Percentage of HbA1c

Measure	Placebo n = 11	Linagliptin 1 mg n = 8	Linagliptin 5 mg n = 13
Value	0.45 (0.31)	-0.03 (0.38)	-0.19 (0.30)

Placebo vs Linagliptin 1 mg: Mean Difference (Net): -0.48 (95% CI -1.47 to 0.51), p = 0.3295, Mixed Models Analysis
Placebo vs Linagliptin 5 mg: Mean Difference (Net): -0.63 (95% CI -1.50 to 0.23), p = 0.1447, Mixed Models Analysis

Population analysed: Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first intake of study drug until 7 days after the last drug administration, up to 13 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 15 (6.7%)	7 of 15 (46.7%)	Not reported
Linagliptin 1 mg	0 of 10 (0%)	8 of 10 (80%)	Not reported
Linagliptin 5 mg	0 of 14 (0%)	6 of 14 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruitingPhase 3
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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

25 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI1356 low dose and BI1356 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 25 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Mexico, Poland, Russia, South Korea, United States and 4 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 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 15 Sep 2016). 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 Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment (time frame: Baseline and 12 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 NCT01342484.

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 15 Sep 2016.