Description:

ODM derived from http://clinicaltrials.gov/show/NCT01435616

Link:

http://clinicaltrials.gov/show/NCT01435616

Keywords:
Versions (2) ▾
  1. 2/7/12
  2. 4/13/14
Uploaded on:

April 13, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01435616 Diabetes Mellitus, Type 2

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age 18 Years and older
Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior to the study
Have been receiving at least 2 oral antihyperglycemic medication for at least 3 months before entering the study
Have hemoglobin A1c value between 7.0% and 11.0%, inclusive, at screening
Are capable of, and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
Woman of Childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization and intend to not become pregnant during the trial. Have practiced a reliable method of birth control for at least 6 weeks prior to screening and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Exclusion Criteria
Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
Have had any episodes of severe hypoglycemia within 6 months prior to screening
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 mg/dL
Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hemoglobin A1c
Have active or untreated malignancy, have been in remission from clinically significant malignancy for less than 5 years
Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5 mmol/L) at screening
Are using lipid lowering medication at a dose that has not been stable for 90 days prior to screening
Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
Medical Concepts