Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)

Phase 4

Recruiting

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT1080222124
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Have a diagnosis of Type 2 Diabetes Mellitus for at least 6 months
Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
Have a qualifying hemoglobin A1c value greater than or equal to 7.0 persent and equal to or lower than 11.0 persent at screening
Have a body mass index (BMI) greater than or equal to 18.5 and less than 35.0 kilogram per square meter
Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site

Exclusion Criteria

Have a diagnosis of type 1 diabetes
Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association class III or class IV heart failure, or cerebrovascular accident (stroke)
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels greater than or equal to 3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula less than 30 milliliter per minute (mL/min), as determined by the central laboratory at screening
Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator
Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for less than 5 years
Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified