Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes

NCT02211963 | Completed Phase 1

• 1 other identifier: 1224.3
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 days in patients with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to 53 days

• Number of patients with clinically significant findings in vital signs (blood pressure (BP), pulse rate (PR))

  up to 18 days

• Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)

  up to 18 days

• Number of patients with clinically relevant laboratory findings

  up to 18 days

• Assessment of tolerability by investigator on a 4-point scale

  Day 18

Secondary Outcomes (21)

• Maximum concentration of the analyte in plasma for several time points (Cmax)

  up to 72 hours after drug administration

• Time from dosing to maximum concentration for several time points (tmax)

  up to 72 hours after drug administration

• Terminal half-life of the analyte in plasma for several time points (t1/2)

  up to 72 hours after drug administration

• Terminal rate constant in plasma for several time points (λz)

  up to 72 hours after drug administration

• Concentration of analyte in plasma for several time points

  12 and 24 hours after drug administration on day 1 and 9

Study Arms (2)

BI 44847

EXPERIMENTAL

Drug: BI 44847

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 44847 DRUG

BI 44847

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and postmenopausal or hysterectomised female patients with proven diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one oral hypoglycaemic agents besides glitazones
• Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5 % at screening for patients treated with diet and exercise and/or one oral hypoglycaemic agent
• Age ≥21 and Age ≤70 years (female hysterectomised and male patients) Age ≥60 and Age ≤70 years (female postmenopausal patients)
• BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
• Clinically relevant concomitant diseases like renal insufficiency (creatinine clearance \< 80 ml/min/173m\*\*2), cardiac insufficiency New York Heart Association II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg, stroke and Transient ischemic attack
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia and medically treated hypertension
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
• Chronic or relevant acute infections (e.g. HIV, Hepatitis)
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial except allowed co-medication
• Use of drugs and/or food which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Antidiabetic treatment with more than one oral hypoglycaemic agent or insulin or glitazones
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 40 g/day = 5 units/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: February 1, 2007
• Primary Completion: June 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08