Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments insulin lispro mix25, insulin lispro mix50
Phase phase 4
Sponsor Eli Lilly and Company
Start date January 2013
End date August 2014
Trial size 400 participants
Trial identifier NCT01773473, 14675, F3Z-CR-IOQI

Summary

The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
insulin lispro mix25 LY275585-75
Administered SC
(Experimental)
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
insulin lispro mix50 LY275585-50
Administered SC

Primary Outcomes

Measure
Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
time frame: Baseline, 26 Weeks

Secondary Outcomes

Measure
Percentage of Participants Achieving HbA1c of <7% or ≤6.5% at 26 Weeks
time frame: 26 Weeks
Change from Baseline in Fasting Serum Glucose at 26 Weeks
time frame: Baseline, 26 Weeks
Change from Baseline in Body Weight at 26 Weeks
time frame: Baseline, 26 Weeks
Number of Hypoglycemic Events at 26 Weeks (Incidence)
time frame: 26 Weeks
Insulin Dose at 26 Weeks
time frame: 26 Weeks
Change from Baseline in 1,5-Anhydroglucitol (1,5-AG) at 26 Weeks
time frame: Baseline, 26 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 ≥7.0% and ≤11.0% at screening - Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m^2) - 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 ≥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 <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 <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

Additional Information

Official title Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.