Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

NCT ID: NCT01924767

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-11-30

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 10773 (dose group 3)

multiple doses as tablet

Group Type: EXPERIMENTAL

BI 10773 Placebo

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773 (dose group 4)

multiple doses as tablet

Group Type: EXPERIMENTAL

BI 10773

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773 Placebo

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773 (dose group 1)

multiple doses as tablet

Group Type: EXPERIMENTAL

BI 10773 Placebo

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773 (dose group 2)

multiple doses as tablet

Group Type: EXPERIMENTAL

BI 10773 Placebo

Intervention Type: DRUG

po taken fasting with 240 mL water

BI 10773

Intervention Type: DRUG

po taken fasting with 240 mL water

Interventions

BI 10773 Placebo

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773

po taken fasting with 240 mL water

Intervention Type: DRUG

BI 10773

po taken fasting with 240 mL water

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.

2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.

3. Age >21 and Age <70 years (male and hysterectomised female patients) Age >60 and Age <70 years (postmenopausal female patients)

4. Body Mass Index (BMI) >18.5 and <40 kg/m2

5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria

1. Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)

2. Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during washout.

3. Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening

4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:

• Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
• Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)
• Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
• Neurological disorders (such as epilepsy) or psychiatric disorders
• Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
• Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder

5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)

7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1245.2.1 Boehringer Ingelheim Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

2007-000654-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.2

Identifier Type: -

Identifier Source: org_study_id