Description:

ODM derived from http://clinicaltrials.gov/show/NCT00770445

Link:

http://clinicaltrials.gov/show/NCT00770445

Keywords:
Versions (3) ▾
  1. 12/6/13
  2. 4/16/14
  3. 9/20/21
Uploaded on:

September 20, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00770445 Diabetes Mellitus

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 30 Years to 75 Years
Has Diabetes Mellitus type 2.
Hemoglobin, Glycosylated
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
Long acting basal insulin analogs
Neutral protamine hagedorn insulin
Combination insulin with 1-2 daily doses except intensified insulin therapies.
Body mass index
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion Criteria
Has a history of type 1 diabetes mellitus.
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
Acute infection
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
Has a history of severe or multiple allergies.
History of drug or alcohol abuse in the past 5 years
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, Glomerular Filtration Rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator
History of macular edema.
State after kidney transplantation.
Serum Potassium Measurement
History of primary hyperaldosteronism.
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Pre-treatment with gemfibrozil within the last 12 weeks.
Pre-treatment with rifampicin within the last 12 weeks.
Treatment with thiazolidinediones within the past 3 months.
If statin therapy applicable: Change of medication within the last 4 weeks.
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
Treatment with any other investigational drug within 4 weeks before trial entry.
Any elective surgery during study participation.
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
Acute or scheduled investigation with iodine containing radiopaque material.
Uncontrolled unstable angina pectoris.
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.

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