NIPH Clinical Trials Search

Basic Information

Recruitment status	recruiting
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	24/06/2013
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Insulin Lispro Mix25 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks. control material(s) Generic name etc : Insulin Lispro Mix50 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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