Diabetes Mellitus, Type 2Phase 2NCT00716092

The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

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

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 objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate 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?: Sitagliptin and Linagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 3 sitesGermany
Study dates: Jul 2008to Nov 2008
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 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 not more than one drug
Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Who cannot join

Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency with a creatinine clearance < 50 mL/min
Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

1218.37.49003 Boehringer Ingelheim Investigational Site
Berlin
1218.37.49002 Boehringer Ingelheim Investigational Site
Mainz
1218.37.49001 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

Official title: A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo (linagliptin), Sitagliptin, Placebo (sitagliptin), 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.

Placebo (linagliptin)Drug
once daily for 28 days
Placebo (linagliptin)Drug
once daily for 28 days
SitagliptinDrug
100 mg once daily for 28 days
Placebo (sitagliptin)Drug
once daily for 28 days
Placebo (sitagliptin)Drug
once daily for 28 days
LinagliptinDrug
5mg once daily for 28 days

Study groups in NCT00716092
Study group	Role	What they receive
Placebo	Placebo comparator	Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. Receives: Drug: Placebo (linagliptin); Drug: Placebo (sitagliptin)
Linagliptin	Experimental	Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. Receives: Drug: Placebo (sitagliptin); Drug: Linagliptin
Sitagliptin	Active comparator	Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin. Receives: Drug: Placebo (linagliptin); Drug: Sitagliptin

What is being measured

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

Weighted Mean Glucose (WMG) Change From Baseline at Day 28
The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.
Measured: Baseline and day 28
GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.
Measured: Baseline and day 28

Secondary outcomes (2)

Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.
Measured: Baseline and day 28
Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).
Measured: Baseline and day 28

Timeline

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

Jul 2008Nov 2008

First posted16 Jul 2008 (estimated)
Study startJul 2008
Primary completionNov 2008

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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00716092
Sponsor's protocol ID: 1218.37
Other IDs: 2007-007865-19
Status last verified: Jan 2014
First submitted: 15 Jul 2008
Last updated: 27 Jun 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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT00716092
Acronym / sponsor ID: 1218.37
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Nov 2008 (actual)
First posted: 16 Jul 2008 (estimated)
Results: Posted 15 Jun 2011

Clinical summary

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

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo (linagliptin), Drug: Placebo (sitagliptin)Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.
Linagliptin	Experimental	Drug: Placebo (sitagliptin), Drug: LinagliptinPatients received 5mg linagliptin, and placebo matching 100mg sitagliptin.
Sitagliptin	Active comparator	Drug: Placebo (linagliptin), Drug: SitagliptinPatients received 100mg sitagliptin, and placebo matching 5mg linagliptin.

Who may qualify

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

Key inclusion criteria (2 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Key exclusion criteria (4 listed)

Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency with a creatinine clearance < 50 mL/min
Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 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
Placebo (linagliptin)once daily for 28 days	Drug	Sitagliptin
Placebo (linagliptin)once daily for 28 days	Drug	Placebo
Sitagliptin100 mg once daily for 28 days	Drug	Sitagliptin
Placebo (sitagliptin)once daily for 28 days	Drug	Linagliptin
Placebo (sitagliptin)once daily for 28 days	Drug	Placebo
Linagliptin5mg once daily for 28 days	Drug	Linagliptin

Primary outcome

Weighted Mean Glucose (WMG) Change From Baseline at Day 28
Time frame: Baseline and day 28
The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.
GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
Time frame: Baseline and day 28
The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.

2 secondary outcomes

Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
Time frame: Baseline and day 28
Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
Time frame: Baseline and day 28

Results and safety

Results posted to the registry on 15 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	40	38
BI1356	40	39
Sitagliptin	41	41

Primary outcome: Weighted Mean Glucose (WMG) Change From Baseline at Day 28

Time frame: Baseline and day 28. Mean (Standard Error). Unit: mg/dL

Measure	Placebo n = 38	BI1356 n = 39	Sitagliptin n = 40
Value	0.1 (3.0)	-19.8 (2.9)	-26.1 (2.8)

Placebo vs BI1356: Mean Difference (Final Values): -19.9 (95% CI -28.0 to -11.9), p <0.0001, ANCOVA

Population analysed: The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups

Primary outcome: GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28

Time frame: Baseline and day 28. Mean (Standard Error). Unit: pmol*h/L

Measure	Placebo n = 38	BI1356 n = 39	Sitagliptin n = 41
Value	0.4 (2.1)	18.5 (2.1)	15.3 (2.0)

Placebo vs BI1356: Mean Difference (Final Values): 18.1 (95% CI 12.4 to 23.9), p <0.0001, ANCOVA

Population analysed: The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first dose until 7 days after last dose, up to 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
BI1356	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
Sitagliptin	0 of 41 (0%)	6 of 41 (14.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

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

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 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?

Weighted Mean Glucose (WMG) Change From Baseline at Day 28 (time frame: Baseline and day 28). The study lists 2 primary outcomes in all. 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 NCT00716092.

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 27 Jun 2014.