Diabetes Mellitus, Type 2Phase 3NCT00800683
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
A Phase 3 study testing BI 1356 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 53 sites in 6 countries.
Trial summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo 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?
- BI 1356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 53 sitesin 6 countries
- Study dates
- Dec 2008to Jan 2011
- 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 type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
- Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
- Age 18 or over and not older than 80 years
Who cannot join
- Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- Unstable or acute congestive heart failure
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
United States24 sites
1218.43.10025 Boehringer Ingelheim Investigational Site
Aiken, South Carolina
1218.43.10023 Boehringer Ingelheim Investigational Site
Austin, Texas
1218.43.10024 Boehringer Ingelheim Investigational Site
Austin, Texas
1218.43.10005 Boehringer Ingelheim Investigational Site
Bethlehem, Pennsylvania
1218.43.10007 Boehringer Ingelheim Investigational Site
Carlisle, Pennsylvania
1218.43.10022 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1218.43.10011 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.43.10014 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.43.10018 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1218.43.10019 Boehringer Ingelheim Investigational Site
Delaware, Ohio
1218.43.10003 Boehringer Ingelheim Investigational Site
Great Neck, New York
1218.43.10016 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1218.43.10017 Boehringer Ingelheim Investigational Site
Lufkin, Texas
1218.43.10008 Boehringer Ingelheim Investigational Site
Mentor, Ohio
1218.43.10013 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1218.43.10027 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1218.43.10001 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
1218.43.10006 Boehringer Ingelheim Investigational Site
Riverside, California
1218.43.10015 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1218.43.10010 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1218.43.10004 Boehringer Ingelheim Investigational Site
The Bronx, New York
1218.43.10009 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
1218.43.10021 Boehringer Ingelheim Investigational Site
Whittier, California
1218.43.10020 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
Israel9 sites
1218.43.97008 Boehringer Ingelheim Investigational Site
Afula
1218.43.97005 Boehringer Ingelheim Investigational Site
Ashkelon
1218.43.97003 Boehringer Ingelheim Investigational Site
Haifa
1218.43.97004 Boehringer Ingelheim Investigational Site
Jerusalem
1218.43.97009 Boehringer Ingelheim Investigational Site
Jerusalem
1218.43.97002 Boehringer Ingelheim Investigational Site
Kfar Saba
1218.43.97007 Boehringer Ingelheim Investigational Site
Nahariya
1218.43.97001 Boehringer Ingelheim Investigational Site
Safed
1218.43.97006 Boehringer Ingelheim Investigational Site
Tel Aviv
Australia7 sites
1218.43.61005 Boehringer Ingelheim Investigational Site
Adelaide, SA
1218.43.61010 Boehringer Ingelheim Investigational Site
Auchenflower, Queensland
1218.43.61009 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
1218.43.61002 Boehringer Ingelheim Investigational Site
Herston, QLD
1218.43.61006 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland
1218.43.61007 Boehringer Ingelheim Investigational Site
Reservoir, Victoria
1218.43.61011 Boehringer Ingelheim Investigational Site
Richmond, Victoria
Ukraine7 sites
1218.43.38003 Boehringer Ingelheim Investigational Site
Kharkiv
1218.43.38004 Boehringer Ingelheim Investigational Site
Kharkiv
1218.43.38006 Boehringer Ingelheim Investigational Site
Kharkiv
1218.43.38005 Boehringer Ingelheim Investigational Site
Kiev
1218.43.38007 Boehringer Ingelheim Investigational Site
Luhansk
1218.43.38008 Boehringer Ingelheim Investigational Site
Ternopil
1218.43.38002 Boehringer Ingelheim Investigational Site
Zaporizhzhya
New Zealand4 sites
1218.43.64001 Boehringer Ingelheim Investigational Site
Auckland
1218.43.64003 Boehringer Ingelheim Investigational Site
Christchurch
1218.43.64004 Boehringer Ingelheim Investigational Site
Takpuna
1218.43.64002 Boehringer Ingelheim Investigational Site
Tauranga
Hong Kong2 sites
1218.43.85201 Boehringer Ingelheim Investigational Site
Hong Kong
1218.43.85203 Boehringer Ingelheim Investigational Site
New Territories
About this study
Official title: Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
to determine safety, efficacy and tolerability of BI 1356 versus placebo
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BI 1356, 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.
BI 1356Drug
BI 1356 dosed once daily
placeboDrug
placebo matching BI 1356 taken once daily
| Study group | Role | What they receive |
|---|---|---|
| BI 1356 | Experimental | patient to receive a tablet containing BI 1356 once daily Receives: Drug: BI 1356 |
| placebo | Placebo comparator | patient to receive a tablet identical to BI 1356 once daily 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 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 12
Secondary outcomes (20)
HbA1c Change From Baseline at Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 52
HbA1c Change From Baseline at Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 18
HbA1c Change From Baseline at Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 24
HbA1c Change From Baseline at Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 30
HbA1c Change From Baseline at Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 36
HbA1c Change From Baseline at Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 42
HbA1c Change From Baseline at Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Measured: Baseline and Week 48
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Measured: Baseline and Week 52
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Measured: Baseline and Week 52
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Measured: Baseline and Week 52
FPG Change From Baseline at Week 12
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 12
FPG Change From Baseline at Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 18
FPG Change From Baseline at Week 24
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 24
FPG Change From Baseline at Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 30
FPG Change From Baseline at Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 36
FPG Change From Baseline at Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 42
FPG Change From Baseline at Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 48
FPG Change From Baseline at week52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Measured: Baseline and Week 52
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Measured: Baseline and Week 52
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Measured: first administration of randomised treatment to ....
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800683
- Sponsor's protocol ID
- 1218.43
- Other IDs
- 2008-001569-27, 2008
- Status last verified
- May 2014
- First submitted
- 1 Dec 2008
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
PubMed 24169807
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
- ClinicalTrials.gov ID
- NCT00800683
- Acronym / sponsor ID
- 1218.43
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Posted 1 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356 | Experimental | Drug: BI 1356patient to receive a tablet containing BI 1356 once daily |
| placebo | Placebo comparator | Drug: placebopatient to receive a tablet identical to BI 1356 once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
- Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
- Age 18 or over and not older than 80 years
Key exclusion criteria (3 listed)
- Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- Unstable or acute congestive heart failure
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 |
|---|---|---|
| BI 1356BI 1356 dosed once daily | Drug | BI 1356 |
| placeboplacebo matching BI 1356 taken once daily | Drug | placebo |
Primary outcome
HbA1c Change From Baseline at Week 12
Time frame: Baseline and Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
20 secondary outcomes
HbA1c Change From Baseline at Week 52
Time frame: Baseline and Week 52
HbA1c Change From Baseline at Week 18
Time frame: Baseline and Week 18
HbA1c Change From Baseline at Week 24
Time frame: Baseline and Week 24
HbA1c Change From Baseline at Week 30
Time frame: Baseline and Week 30
HbA1c Change From Baseline at Week 36
Time frame: Baseline and Week 36
HbA1c Change From Baseline at Week 42
Time frame: Baseline and Week 42
HbA1c Change From Baseline at Week 48
Time frame: Baseline and Week 48
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
Time frame: Baseline and Week 52
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
Time frame: Baseline and Week 52
FPG Change From Baseline at Week 12
Time frame: Baseline and Week 12
FPG Change From Baseline at Week 18
Time frame: Baseline and Week 18
FPG Change From Baseline at Week 24
Time frame: Baseline and Week 24
FPG Change From Baseline at Week 30
Time frame: Baseline and Week 30
FPG Change From Baseline at Week 36
Time frame: Baseline and Week 36
FPG Change From Baseline at Week 42
Time frame: Baseline and Week 42
FPG Change From Baseline at Week 48
Time frame: Baseline and Week 48
FPG Change From Baseline at week52
Time frame: Baseline and Week 52
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Time frame: Baseline and Week 52
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Time frame: first administration of randomised treatment to ....
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24169807McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
- 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
53 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BI 1356 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 53 sites in 6 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 3 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Israel, Australia, Ukraine, New Zealand 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 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 1 Feb 2012). 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 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 NCT00800683, which also lists 1 linked publication.
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 20 May 2014.