Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02150824
First received: May 28, 2014
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: BI 187004
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Three BI 187004 Doses Given Once Daily as Mono-therapy and of the Highest BI 187004 Dose Given Once Daily as Add on Treatment to Metformin Over 28 Days in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The percentage of patients with drug- related adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 187004 low dose mono QD
patient to receive one tablet containing low dose of BI 187004 or matching placebo
Drug: Placebo
BI 187004 low dose matching placebo once daily
Drug: BI 187004
BI 187004 low dose once daily
Experimental: BI 187004 medium dose mono QD
patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
Drug: Placebo
BI 187004 medium dose matching placebo once daily
Drug: BI 187004
BI 187004 medium dose once daily
Experimental: BI 187004 high dose mono QD
patient to receive one tablet containing high dose of BI 187004 or matching placebo
Drug: Placebo
BI 187004 high dose matching placebo once daily
Drug: BI 187004
BI 187004 high dose once daily
Experimental: BI 187004 high dose QD add on
patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
Drug: Placebo
BI 187004 high dose matching placebo once daily add on to background metformin
Drug: BI 187004
BI 187004 high dose once daily add on to background metformin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or postmenopausal or hysterectomised female patients with diagnosis of Type 2 Diabetes Mellitus (T2DM) before informed consent
  2. To be eligible for Arm 1

    1. Oral antidiabetic mono-therapy for the last 12 weeks prior to Informed Consent AND Glycosylated haemoglobin (HbA1c) >= 6.5% and <= 8.5% at Visit 1a
    2. Therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to Informed Consent AND HbA1c >= 7.0% and <= 9.5% at Visit 1a.
  3. To be eligible for Arm 2:

    a. Antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to Informed Consent AND patient´s willingness to keep this therapy stable during the course of the trial AND HbA1c >= 7.0% and <= 9.5% at Visit 1a

  4. Age >=18 and <=80 years for female hysterectomised and male patients at Visit 1a
  5. Age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at Visit 1a
  6. Body mass index (BMI) >= 28 and <= 40 kg/m2 at Visit 1a
  7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

  1. Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
  2. Fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
  3. Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
  4. Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
  5. Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a.
  6. History of Cushing syndrome, Addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
  7. Treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
  8. Treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
  9. Use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
  10. Surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
  11. Any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. Smoking habits interfering with hospitalization. Patients not willing to abstain from alcoholic beverages during inpatient visits
  12. Male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02150824

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Germany
1307.4.49003 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1307.4.49002 Boehringer Ingelheim Investigational Site Recruiting
Mainz, Germany
1307.4.49001 Boehringer Ingelheim Investigational Site Recruiting
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02150824     History of Changes
Other Study ID Numbers: 1307.4, 2013-003646-16
Study First Received: May 28, 2014
Last Updated: August 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014