Diabetes Mellitus, Type 2Phase 3NCT01087502

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

A Phase 3 study testing Glimepiride and Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 52 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 objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Glimepiride and Linagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 241 participants
Where: 52 sitesin 9 countries
Study dates: Mar 2010to May 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus
GFR<60 ml/min
HbA1c >=7.0% to <= 10%
Age >= 18 years
BMI <=45 kg/m2
Signed and dated written informed consent

Who cannot join

Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Renal impairment requiring dialysis
Bariatric surgery
Impaired hepatic function
Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
Treatment with anti-obesity drugs
Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Trial locations and contacts

52 sites in 9 countries.

Country

City, postcode or hospital

52 sites in 9 countries

United States16 sites

1218.64.10009 Boehringer Ingelheim Investigational Site
Arlington, Texas
1218.64.10015 Boehringer Ingelheim Investigational Site
Boise, Idaho
1218.64.10002 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1218.64.10007 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.64.10005 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.64.10016 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1218.64.10004 Boehringer Ingelheim Investigational Site
Flint, Michigan
1218.64.10011 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.64.10014 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.64.10006 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1218.64.10018 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1218.64.10013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.64.10020 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.64.10008 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1218.64.10010 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1218.64.10003 Boehringer Ingelheim Investigational Site
The Bronx, New York

Other trials in United States

Japan8 sites

1218.64.81005 Boehringer Ingelheim Investigational Site
Asahi, Chiba
1218.64.81006 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
1218.64.81001 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
1218.64.81008 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.64.81007 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.64.81002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1218.64.81004 Boehringer Ingelheim Investigational Site
Suita, Osaka
1218.64.81003 Boehringer Ingelheim Investigational Site
Suwa, Nagano

Other trials in Japan

Canada7 sites

1218.64.20008 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1218.64.20005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.64.20007 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.64.20003 Boehringer Ingelheim Investigational Site
Point Claire, Quebec
1218.64.20002 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.64.20009 Boehringer Ingelheim Investigational Site
Stayner, Ontario
1218.64.20004 Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

Israel6 sites

1218.64.97204 Boehringer Ingelheim Investigational Site
Ashkelon
1218.64.97207 Boehringer Ingelheim Investigational Site
Giv‘atayim
1218.64.97203 Boehringer Ingelheim Investigational Site
Haifa
1218.64.97201 Boehringer Ingelheim Investigational Site
Jerusalem
1218.64.97202 Boehringer Ingelheim Investigational Site
Nahariya
1218.64.97206 Boehringer Ingelheim Investigational Site
Tel Aviv

Other trials in Israel

Australia5 sites

1218.64.61003 Boehringer Ingelheim Investigational Site
Adelaide, South Australia
1218.64.61005 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
1218.64.61001 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales
1218.64.61004 Boehringer Ingelheim Investigational Site
Reservoir, Victoria
1218.64.61002 Boehringer Ingelheim Investigational Site
St Leonards, New South Wales

Other trials in Australia

Slovakia4 sites

1218.64.42102 Boehringer Ingelheim Investigational Site
Bratislava
1218.64.42107 Boehringer Ingelheim Investigational Site
Košice
1218.64.42109 Boehringer Ingelheim Investigational Site
Nitra
1218.64.42108 Boehringer Ingelheim Investigational Site
Trenčín

Other trials in Slovakia

Finland3 sites

1218.64.35804 Boehringer Ingelheim Investigational Site
Kokkola
1218.64.35803 Boehringer Ingelheim Investigational Site
Oulu
1218.64.35801 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

Sweden2 sites

1218.64.46002 Boehringer Ingelheim Investigational Site
Härnösand
1218.64.46003 Boehringer Ingelheim Investigational Site
Helsingborg

Other trials in Sweden

New Zealand1 site

1218.64.64001 Boehringer Ingelheim Investigational Site
Otahuhu Auckland

Other trials in New Zealand

About this study

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control

Conditions: Diabetes Mellitus, Type 2
Being tested: Glimepiride, Placebo, 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.

GlimepirideDrug
1-4 mg daily after 12 weeks
PlaceboDrug
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
PlaceboDrug
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
PlaceboDrug
Placebo mach to 5 mg linagliptin once daily after 12 weeks
LinagliptinDrug
5 mg once daily

Study groups in NCT01087502
Study group	Role	What they receive
Linagliptin	Experimental	52 weeks treatment Receives: Drug: Placebo; Drug: Linagliptin
Placebo	Placebo comparator	First 12 weeks of treatment Receives: Drug: Placebo
Glimepiride	Active comparator	Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment) Receives: Drug: Glimepiride; Drug: Placebo

What is being measured

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

HbA1c Change From Baseline to 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, renal function impairment and prior use of antidiabetic agents.
Measured: Baseline and week 12

Secondary outcomes (7)

HbA1c Change From Baseline Over Time
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Fasting Plasma Glucose (FPG) Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction.
Measured: Baseline and week 12
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Measured: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Percentage of Patients With HbA1c <7.0%
The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
Measured: Baseline, week 12 and week 52
Percentage of Patients With HbA1c <6.5%
The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
Measured: Baseline, week 12 and week 52
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
Measured: Baseline, week 12 and week 52
Plasma Concentration of Linagliptin at Trough
Trough levels of concentration of Linagliptin in plasma.
Measured: Week 12, 24 and 52

Timeline

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

Mar 2010May 2012

First posted16 Mar 2010 (estimated)
Study startMar 2010
Primary completionMay 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: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01087502
Sponsor's protocol ID: 1218.64
Other IDs: 2009-016971-31, 2009
Status last verified: May 2014
First submitted: 15 Mar 2010
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 Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01087502
Acronym / sponsor ID: 1218.64
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Mar 2010
Primary completion: May 2012 (actual)
First posted: 16 Mar 2010 (estimated)
Results: Posted 17 Oct 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: 3

Arm	Type	Receives
Linagliptin	Experimental	Drug: Placebo, Drug: Linagliptin52 weeks treatment
Placebo	Placebo comparator	Drug: PlaceboFirst 12 weeks of treatment
Glimepiride	Active comparator	Drug: Glimepiride, Drug: PlaceboPlacebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Who may qualify

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

Key inclusion criteria (6 listed)

Type 2 diabetes mellitus
GFR<60 ml/min
HbA1c >=7.0% to <= 10%
Age >= 18 years
BMI <=45 kg/m2

Key exclusion criteria (7 listed)

Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Renal impairment requiring dialysis
Bariatric surgery
Impaired hepatic function
Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors

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
Glimepiride1-4 mg daily after 12 weeks	Drug	Glimepiride
PlaceboPlacebo mach to 5 mg linagliptin first 12 weeks of treatment once daily	Drug	Placebo
PlaceboPlacebo maching Glimepiride 1-4 mg after 12 weeks of treatment	Drug	Linagliptin
PlaceboPlacebo mach to 5 mg linagliptin once daily after 12 weeks	Drug	Glimepiride
Linagliptin5 mg once daily	Drug	Linagliptin

Primary outcome

HbA1c Change From Baseline to Week 12
Time frame: Baseline and 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, renal function impairment and prior use of antidiabetic agents.

7 secondary outcomes

HbA1c Change From Baseline Over Time
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Fasting Plasma Glucose (FPG) Change From Baseline to Week 12
Time frame: Baseline and week 12
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Time frame: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Percentage of Patients With HbA1c <7.0%
Time frame: Baseline, week 12 and week 52
Percentage of Patients With HbA1c <6.5%
Time frame: Baseline, week 12 and week 52
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
Time frame: Baseline, week 12 and week 52
Plasma Concentration of Linagliptin at Trough
Time frame: Week 12, 24 and 52

Results and safety

Results posted to the registry on 17 Oct 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/Glimepiride	123	114
Linagliptin 5 mg	118	110

Primary outcome: HbA1c Change From Baseline to Week 12

Time frame: Baseline and week 12. Mean (Standard Error). Unit: Percent

Measure	Placebo n = 120	Linagliptin 5 mg n = 113
Value	-0.11 (0.11)	-0.53 (0.11)

Placebo vs Linagliptin 5 mg: Mean Difference (Final Values): -0.42 (95% CI -0.60 to -0.24), p <0.0001, ANCOVA

Population analysed: FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule. Results for primary endpoint below are the ones reproduced without patients from the excluded study site.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Glimepiride	36 of 122 (29.5%)	110 of 122 (90.2%)	Not reported
Linagliptin 5 mg	28 of 113 (24.8%)	95 of 113 (84.1%)	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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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glimepiride and Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 52 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 6 inclusion and 7 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 52 sites in United States, Japan, Canada, Israel, Australia 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 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 17 Oct 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 to Week 12 (time frame: Baseline and 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 NCT01087502.

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.