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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00601250




Registration number
NCT00601250
Ethics application status
Date submitted
15/01/2008
Date registered
28/01/2008
Date last updated
28/01/2014

Titles & IDs
Public title
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Scientific title
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Secondary ID [1] 0 0
2007-002457-24
Secondary ID [2] 0 0
1218.17
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 - linagliptin
Treatment: Drugs - linagliptin

Experimental: Linagliptin - Patients receive linagliptin 5 mg tablets once daily

Placebo Comparator: Placebo - Patients receive placebo tablets matching linagliptin 5 mg tablets once daily


Treatment: Drugs: linagliptin
Patients receive linagliptin 5 mg tablets once daily

Treatment: Drugs: linagliptin
Patients receive linagliptin 5 mg tablets once daily

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

Outcomes
Primary outcome [1] 0 0
HbA1c Change From Baseline at Week 24 - HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Timepoint [1] 0 0
Baseline and week 24
Secondary outcome [1] 0 0
HbA1c Change From Baseline at Week 6 - HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Timepoint [1] 0 0
Baseline and week 6
Secondary outcome [2] 0 0
HbA1c Change From Baseline at 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 and previous anti-diabetic medication.
Timepoint [2] 0 0
Baseline and week 12
Secondary outcome [3] 0 0
HbA1c Change From Baseline at Week 18 - HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Timepoint [3] 0 0
Baseline and week 18
Secondary outcome [4] 0 0
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 baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Timepoint [4] 0 0
Baseline and week 24
Secondary outcome [5] 0 0
FPG Change From Baseline at Week 6 - This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Timepoint [5] 0 0
Baseline and week 6
Secondary outcome [6] 0 0
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 baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Timepoint [6] 0 0
Baseline and week 12
Secondary outcome [7] 0 0
FPG Change From Baseline at Week 18 - This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Timepoint [7] 0 0
Baseline and week 18
Secondary outcome [8] 0 0
Percentage of Patients With HbA1c <7.0% at Week 24. - The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%
Timepoint [8] 0 0
Baseline and week 24
Secondary outcome [9] 0 0
Percentage of Patients With HbA1c < 7.0% at Week 24 - The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.
Timepoint [9] 0 0
Baseline and week 24
Secondary outcome [10] 0 0
Percentage of Patients With HbA1c <6.5% at Week 24 - The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%
Timepoint [10] 0 0
Baseline and week 24
Secondary outcome [11] 0 0
Percentage of Patients With HbA1c<6.5% at Week 24 - The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.
Timepoint [11] 0 0
Baseline and week 24
Secondary outcome [12] 0 0
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24 - The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.
Timepoint [12] 0 0
Baseline and week 24
Secondary outcome [13] 0 0
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 - This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
Timepoint [13] 0 0
Baseline and week 24
Secondary outcome [14] 0 0
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24 - This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.
Timepoint [14] 0 0
Baseline and week 24

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously
treated with metformin alone, or with metformin and not more than one other oral
antidiabetic drug

2. Diagnosis of type 2 diabetes prior to informed consent

3. Glycosylated haemoglobin A1 (HbA1c)at screening:

For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients
not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in

5. Age 18 -80 years

6. BMI (Body Mass Index) less than 40 kg/m2

7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP
and local legislation
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior
to informed consent

2. Impaired hepatic function

3. Known hypersensitivity or allergy to the investigational product or its excipients or
metformin or placebo

4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent

5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to
informed consent

6. Treatment with insulin within 3 months prior to informed consent

7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3
months prior to informed consent

8. Alcohol abuse within the 3 months prior to informed consent that would interfere with
trial participation or drug abuse

9. Participation in another trial with an investigational drug within 2 months prior to
informed consent

10. Pre-menopausal women who:

- are nursing or pregnant,

- or are of child-bearing potential and are not practicing an acceptable method of
birth control, or do not plan to continue using this method throughout the study
and do not agree to submit to periodic pregnancy testing during participation in
the trial.

11. Current treatment with systemic steroids at time of informed consent or change in
dosage of thyroid hormones within 6 weeks prior to informed consent.

12. Renal failure or renal impairment

13. Unstable or acute congestive heart failure

14. Acute or chronic metabolic acidosis (present in patient history)

15. Hereditary galactose intolerance

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)
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Breclav
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Hodonin
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Olomouc
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
Finland
State/province [18] 0 0
Jyväskylä
Country [19] 0 0
Finland
State/province [19] 0 0
Kuopio
Country [20] 0 0
Finland
State/province [20] 0 0
Oulu
Country [21] 0 0
Finland
State/province [21] 0 0
Seinäjoki
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Greece
State/province [24] 0 0
Piraeus
Country [25] 0 0
India
State/province [25] 0 0
Andhra Pradesh
Country [26] 0 0
India
State/province [26] 0 0
Bangalore
Country [27] 0 0
India
State/province [27] 0 0
Chennai
Country [28] 0 0
India
State/province [28] 0 0
Hyderabad
Country [29] 0 0
India
State/province [29] 0 0
Jaipur
Country [30] 0 0
India
State/province [30] 0 0
Karnataka
Country [31] 0 0
India
State/province [31] 0 0
Mangalore
Country [32] 0 0
India
State/province [32] 0 0
Mumbai
Country [33] 0 0
India
State/province [33] 0 0
Nagpur
Country [34] 0 0
India
State/province [34] 0 0
Nasik
Country [35] 0 0
India
State/province [35] 0 0
Trivandrum
Country [36] 0 0
India
State/province [36] 0 0
Uttar Pradesh
Country [37] 0 0
Israel
State/province [37] 0 0
Afula
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Holon
Country [40] 0 0
Israel
State/province [40] 0 0
Jerusalem
Country [41] 0 0
Israel
State/province [41] 0 0
Nahariya
Country [42] 0 0
Israel
State/province [42] 0 0
Safed
Country [43] 0 0
Israel
State/province [43] 0 0
Tel Aviv
Country [44] 0 0
Mexico
State/province [44] 0 0
Aguascalientes, Ags.
Country [45] 0 0
Mexico
State/province [45] 0 0
cOL OBREGON,León, Guanajuato
Country [46] 0 0
Mexico
State/province [46] 0 0
Col. Lomas de San Francisco, Monterrey
Country [47] 0 0
Mexico
State/province [47] 0 0
Col. Mitras Centro, Monterrey, N.L.
Country [48] 0 0
Mexico
State/province [48] 0 0
Col.Americana, Guadalajara, Jalisco
Country [49] 0 0
Mexico
State/province [49] 0 0
Colonia Reforma Social
Country [50] 0 0
Mexico
State/province [50] 0 0
Colonia Tlalpan, mexico
Country [51] 0 0
Mexico
State/province [51] 0 0
Faccionamiento Lomas de Campestre,AGUASCAL
Country [52] 0 0
Mexico
State/province [52] 0 0
Mexico
Country [53] 0 0
Mexico
State/province [53] 0 0
Tlalpan-México D,F
Country [54] 0 0
New Zealand
State/province [54] 0 0
Christchurch
Country [55] 0 0
New Zealand
State/province [55] 0 0
Dunedin
Country [56] 0 0
New Zealand
State/province [56] 0 0
Otahuhu
Country [57] 0 0
New Zealand
State/province [57] 0 0
Tauranga
Country [58] 0 0
New Zealand
State/province [58] 0 0
Wellington
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Novosibirsk
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Perm
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Tomsk
Country [63] 0 0
Sweden
State/province [63] 0 0
Härnösand
Country [64] 0 0
Sweden
State/province [64] 0 0
Malmö
Country [65] 0 0
Sweden
State/province [65] 0 0
Uddevalla
Country [66] 0 0
Sweden
State/province [66] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the current study is to investigate the efficacy, safety and tolerability of
BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Trial website
https://clinicaltrials.gov/show/NCT00601250
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