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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01087502




Registration number
NCT01087502
Ethics application status
Date submitted
15/03/2010
Date registered
16/03/2010
Date last updated
27/06/2014

Titles & IDs
Public title
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Scientific 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
Secondary ID [1] 0 0
2009-016971-31
Secondary ID [2] 0 0
1218.64
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glimepiride
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Linagliptin

Experimental: Linagliptin - 52 weeks treatment

Placebo Comparator: Placebo - First 12 weeks of treatment

Active Comparator: Glimepiride - Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)


Treatment: Drugs: Glimepiride
1-4 mg daily after 12 weeks

Treatment: Drugs: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily

Treatment: Drugs: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment

Treatment: Drugs: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks

Treatment: Drugs: Linagliptin
5 mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Secondary outcome [4] 0 0
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%.
Timepoint [4] 0 0
Baseline, week 12 and week 52
Secondary outcome [5] 0 0
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%.
Timepoint [5] 0 0
Baseline, week 12 and week 52
Secondary outcome [6] 0 0
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%.
Timepoint [6] 0 0
Baseline, week 12 and week 52
Secondary outcome [7] 0 0
Plasma Concentration of Linagliptin at Trough - Trough levels of concentration of Linagliptin in plasma.
Timepoint [7] 0 0
Week 12, 24 and 52

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Type 2 diabetes mellitus

2. GFR<60 ml/min

3. HbA1c >=7.0% to <= 10%

4. Age >= 18 years

5. BMI <=45 kg/m2

6. Signed and dated written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

2. Renal impairment requiring dialysis

3. Bariatric surgery

4. Impaired hepatic function

5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors

6. Treatment with anti-obesity drugs

7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
1218.64.61005 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
1218.64.61001 Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [3] 0 0
1218.64.61002 Boehringer Ingelheim Investigational Site - St Leonards
Recruitment hospital [4] 0 0
1218.64.61003 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [5] 0 0
1218.64.61004 Boehringer Ingelheim Investigational Site - Reservoir
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- St Leonards
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Reservoir
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Finland
State/province [14] 0 0
Kokkola
Country [15] 0 0
Finland
State/province [15] 0 0
Oulu
Country [16] 0 0
Finland
State/province [16] 0 0
Turku
Country [17] 0 0
Israel
State/province [17] 0 0
Ashkelon
Country [18] 0 0
Israel
State/province [18] 0 0
Givatayim
Country [19] 0 0
Israel
State/province [19] 0 0
Haifa
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Nahariya
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Aviv
Country [23] 0 0
Japan
State/province [23] 0 0
Asahi, Chiba
Country [24] 0 0
Japan
State/province [24] 0 0
Isesaki, Gunma
Country [25] 0 0
Japan
State/province [25] 0 0
Meguro-ku, Tokyo
Country [26] 0 0
Japan
State/province [26] 0 0
Nagoya, Aichi
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka, Osaka
Country [28] 0 0
Japan
State/province [28] 0 0
Shinjyuku-ku,Tokyo
Country [29] 0 0
Japan
State/province [29] 0 0
Suita, Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Suwa, Nagano
Country [31] 0 0
New Zealand
State/province [31] 0 0
Otahuhu Auckland
Country [32] 0 0
Slovakia
State/province [32] 0 0
Bratislava
Country [33] 0 0
Slovakia
State/province [33] 0 0
Kosice
Country [34] 0 0
Slovakia
State/province [34] 0 0
Nitra
Country [35] 0 0
Slovakia
State/province [35] 0 0
Trencin
Country [36] 0 0
Sweden
State/province [36] 0 0
Helsingborg
Country [37] 0 0
Sweden
State/province [37] 0 0
Härnösand

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. In addition safety in this patient population with longer
term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Trial website
https://clinicaltrials.gov/show/NCT01087502
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications