Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes

NCT02212925 | Terminated Phase 1

• 1 other identifier: 1233.2
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 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 14 days after last drug administration

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

  up to 14 days after last drug administration

• Number of patients with clinically significant findings in ECG

  up to 14 days after last drug administration

• Number of patients with clinically significant findings in laboratory tests

  up to 14 days after last drug administration

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

  up to 14 days after last drug administration

Secondary Outcomes (14)

• Cmax (maximum concentration of the analyte in plasma)

  up to 18 days after first drug administration

• tmax (time from dosing to maximum concentration)

  up to 18 days after first drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval)

  up to 18 days after first drug administration

• AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose)

  up to 18 days after first drug administration

• Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 h to 24 h)

  up to 11 days after first drug administration

Study Arms (2)

BI 14332 CL

EXPERIMENTAL

Drug: BI 14332 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 14332 CL DRUG

BI 14332 CL

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 diagnosis of type 2 diabetes mellitus treated with diet and exercise only, or with one oral hypoglycaemic agent besides glitazones and who are not taking the maximum approved dose
• Glycosylated haemoglobin A1 (HbA1c) ≥ 6.5% and ≤ 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)
• Body Mass Index (BMI) ≥18.5 and BMI ≤35 kg/m2

You may not qualify if:

• Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of not acceptable clinical relevance
• Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 140/90 mmHg, 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 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 and anti-hypertensive treatment with verapamil or diltiazem
• 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: November 1, 2006
• Primary Completion: March 1, 2007
• Last Updated: August 8, 2014

Record last verified: 2014-08