Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT01334606
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus
* Have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening
* Use a pen device to self-administer greater than 40 units of Lantus, Levemir, and/or NPH in one or more single injections. For split doses, at least one of the injections must deliver more than 40 units.
* Documented hemoglobin A1c (HbA1c) from 5.5% to 9.5%, inclusive
* Self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study
* On a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening
* Able to read, write and follow instructions in English
Exclusion Criteria:
* Current administration of insulin with a pump.
* Current use a syringe to inject insulin or any diabetes-related medication
* Participation in clinical study BDDC-08-011 or DBC-10-SQUIR05
* History of intravenous drug abuse.
* Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc).
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01334606
Study Brief:
Protocol Section:
NCT01334606