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 naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002311-27-CZ
• Date of registration: 22/08/2006
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
• Public 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 naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)
• 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 naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)
• Date of first enrolment: 14/09/2006
• Target sample size: 375
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002311-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
1.Male and female patients with 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 month.
3.Glycosilated 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 GCP and local regislation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Clinically relevant cardiovascular disease ( e.g. myocardial infarction, stroke or TIA within six month before enrolment)
2.Impaired hepatic function defined by serum levels of either ALT ( SGPT), AST ( SGOT) 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 screening
4.Disease 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., HIV, 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 month prior to screening
8.Treatment with insulin within 3 month prior to screening
9.Alcohol or drug abuse within the last 3 month that would interfere with trial participation
10.Participation in another trial with an investigational drug within two month prior to administration or during the trial
11.Fasting plasma glucose > 240 mg/dl (=13.3 mmol/L) at Visits 2, 3 or 4 any visit and confirmed by a second measurement ( not the same day)
12.Pre-menopausal women ( last menstruation = year prior to signing informed consent) who:
- are not surgically sterile
- 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. Acceptable methods of birth control include transdermal patch, intra uterine devices ( IUDs), oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
13.Intolerance of metformin.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Type 2 diabetes
MedDRA version: 8.1 Level: PT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent

Intervention(s)

Product Name: BI 1356 BS
Product Code: BI 1356 BS
Pharmaceutical Form: Tablet
Current Sponsor code: BI 1356
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: BI 1356 BS
Product Code: BI 1356 BS
Pharmaceutical Form: Tablet
Current Sponsor code: BI 1356
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: BI 1356 BS
Product Code: BI 1356 BS
Pharmaceutical Form: Tablet
Current Sponsor code: BI 1356
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Glugophage
Product Name: Glucophage
Pharmaceutical Form: Tablet
INN or Proposed INN: metformin
CAS Number: 657249
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Glucophage
Product Name: Glucophage
Pharmaceutical Form: Tablet
INN or Proposed INN: metformin
CAS Number: 657249
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

Primary end point(s): Change of HbA1c ( HbA1c at 12 weeks of treatment minus HbA1c at baseline). Throughout the study protocol the term “baseline” refers to the last observation prior to any study treatment.

Main Objective: Investigate the efficacy, safety and tolerability of several doses of BI 1356 BS ( 0.5 mg, 2.5 mg and 5.0 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. An open label treatment arm with, metformin will be used for sensitivity analysis. Population pharmacokinetics of BI 1356 BS will also be assessed.

Secondary Objective:

Secondary ID(s)

1218.5