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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00328172




Registration number
NCT00328172
Ethics application status
Date submitted
18/05/2006
Date registered
19/05/2006
Date last updated
14/03/2014

Titles & IDs
Public title
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Scientific title
A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
Secondary ID [1] 0 0
1218.5
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 - Placebo
Treatment: Drugs - BI 1356 dose 3 once daily
Treatment: Drugs - BI 1356 dose 2 once daily
Treatment: Drugs - BI 1356 dose 1 once daily
Treatment: Drugs - Metformin

Placebo Comparator: Placebo - Placebo tablets matching BI 1356

Experimental: BI 1356 0.5 mg - BI 1356 dose 1 once daily

Experimental: BI 1356 2.5 mg - BI 1356 dose 2 once daily

Experimental: BI 1356 5.0 mg - BI 1356 dose 3 once daily

Active Comparator: Metformin - Metformin


Treatment: Drugs: Placebo
Placebo matching BI 1356

Treatment: Drugs: BI 1356 dose 3 once daily
BI 1356 dose 3 once daily

Treatment: Drugs: BI 1356 dose 2 once daily
BI 1356 dose 2 once daily

Treatment: Drugs: BI 1356 dose 1 once daily
BI 1356 dose 1 once daily

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
Timepoint [1] 0 0
Baseline, week 12
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Timepoint [1] 0 0
Baseline, week 12
Secondary outcome [2] 0 0
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks
Timepoint [2] 0 0
Baseline, week 12

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet
and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single
treatment or in combination) other than rosiglitazone or pioglitazone -treatment.
Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.

2. Diagnosis of Type 2 diabetes with duration of at least 3 months

3. Glycosylated haemoglobin A1 (HbA1c) of:

7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at
screening for patients treated with only one oral antidiabetic agent (wash-out
required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents
(wash-out required)

4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).

5. Age >=21 and <=75 years.

6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.

7. Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice (GCP) and local legislation
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or
transient ischemic attack within six months before enrollment)

2. Impaired hepatic function defined by serum levels of either alanine aminotransferase,
aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal

3. Renal insufficiency or impaired renal function defined by serum creatinine above upper
limit of normal at screening

4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
clinically relevant neurologic disorders (including cerebrovascular but with the
exception of polyneuropathy) that would interfere with participation in the trial

5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus,
Hepatitis)

6. History of relevant allergy/hypersensitivity that would interfere with trial
participation (including allergy to investigational product or its excipients)

7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening

8. Treatment with insulin within 3 months prior to screening

9. Alcohol or drug abuse within the last 3 months that would interfere with trial
participation)

10. Participation in another trial with an investigational drug within two months prior to
administration or during the trial

11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and
confirmed by a second measurement (not on the same day)

12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent)
who:

1. are not surgically sterile,

2. or are nursing or pregnant;

3. 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. Acceptable methods of birth control include transdermal patch,
intra-uterine devices, oral, implantable or injectable contraceptives and
vasectomised partner. No exception will be made.

13. Intolerance of metformin

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 2
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
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
1218.5.61001 Boehringer Ingelheim Investigational Site - Miranda
Recruitment hospital [2] 0 0
1218.5.61005 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [3] 0 0
1218.5.61006 Boehringer Ingelheim Investigational Site - Dandenong
Recruitment hospital [4] 0 0
1218.5.61007 Boehringer Ingelheim Investigational Site - East Ringwood
Recruitment hospital [5] 0 0
1218.5.61004 Boehringer Ingelheim Investigational Site - Fremantle
Recruitment hospital [6] 0 0
1218.5.61002 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Miranda
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Dandenong
Recruitment postcode(s) [4] 0 0
- East Ringwood
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Canada
State/province [19] 0 0
Alberta
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Canada
State/province [20] 0 0
British Columbia
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Canada
State/province [21] 0 0
Manitoba
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Canada
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Ontario
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Canada
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Prince Edward Island
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Canada
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Quebec
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Canada
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Saskatchewan
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Czech Republic
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Olomouc 9
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Czech Republic
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Praha 4
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Czech Republic
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Praha 9
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Czech Republic
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Sternberk
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Lvov
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Ukraine
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Vinnitsa

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
several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of
treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition,
there will be an open-label treatment arm with metformin for sensitivity measurement with
this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in
this study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00328172
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00328172