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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Baseline and week 24
Secondary outcome [1] 0 0
HbA1c Change From Baseline at Week 6
Timepoint [1] 0 0
Baseline and week 6
Secondary outcome [2] 0 0
HbA1c Change From Baseline at Week 12
Timepoint [2] 0 0
Baseline and week 12
Secondary outcome [3] 0 0
HbA1c Change From Baseline at Week 18
Timepoint [3] 0 0
Baseline and week 18
Secondary outcome [4] 0 0
FPG Change From Baseline at Week 24
Timepoint [4] 0 0
Baseline and week 24
Secondary outcome [5] 0 0
FPG Change From Baseline at Week 6
Timepoint [5] 0 0
Baseline and week 6
Secondary outcome [6] 0 0
FPG Change From Baseline at Week 12
Timepoint [6] 0 0
Baseline and week 12
Secondary outcome [7] 0 0
FPG Change From Baseline at Week 18
Timepoint [7] 0 0
Baseline and week 18
Secondary outcome [8] 0 0
Percentage of Patients With HbA1c <7.0% at Week 24.
Timepoint [8] 0 0
Baseline and week 24
Secondary outcome [9] 0 0
Percentage of Patients With HbA1c < 7.0% at Week 24
Timepoint [9] 0 0
Baseline and week 24
Secondary outcome [10] 0 0
Percentage of Patients With HbA1c <6.5% at Week 24
Timepoint [10] 0 0
Baseline and week 24
Secondary outcome [11] 0 0
Percentage of Patients With HbA1c<6.5% at Week 24
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
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
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
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
Sex
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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
701
Recruitment in Australia
Recruitment state(s)
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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Illinois
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Nebraska
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North Carolina
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Ohio
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Oklahoma
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Oregon
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South Carolina
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Texas
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Washington
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Czech Republic
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Breclav
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Czech Republic
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Brno
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Czech Republic
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Hodonin
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Czech Republic
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Olomouc
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Finland
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Helsinki
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Finland
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Jyväskylä
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Finland
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Kuopio
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Oulu
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Finland
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Seinäjoki
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Finland
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Turku
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Greece
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Athens
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Greece
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Piraeus
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India
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Andhra Pradesh
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India
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Bangalore
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India
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Chennai
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India
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Hyderabad
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India
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Jaipur
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India
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Mangalore
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Mumbai
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Nagpur
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Nasik
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India
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Trivandrum
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India
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Uttar Pradesh
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Israel
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Afula
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Safed
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Israel
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Tel Aviv
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Mexico
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Aguascalientes, Ags.
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Mexico
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cOL OBREGON,León, Guanajuato
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Mexico
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Col. Lomas de San Francisco, Monterrey
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Mexico
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Col. Mitras Centro, Monterrey, N.L.
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Mexico
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Col.Americana, Guadalajara, Jalisco
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Mexico
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Colonia Reforma Social
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Colonia Tlalpan, mexico
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Faccionamiento Lomas de Campestre,AGUASCAL
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Mexico
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Mexico
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Tlalpan-México D,F
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Otahuhu
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New Zealand
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Tauranga
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New Zealand
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Wellington
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Perm
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Russian Federation
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Tomsk
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Sweden
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Härnösand
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Sweden
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Malmö
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Sweden
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Uddevalla
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Sweden
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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/study/NCT00601250
Trial related presentations / publications
Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
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/study/NCT00601250