Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

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Lilly

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin Lispro Mix25
Drug: Insulin Lispro Mix50

Study type

Interventional

Funder types

Industry

Identifiers

NCT01773473
14675
F3Z-CR-IOQI (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

403 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) 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 (HbA1C) value ≥7.0% and ≤11.0% at screening
  • Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)
  • 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 (NYHA) 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

403 participants in 2 patient groups

Insulin Lispro Mix25
Experimental group
Description:
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
Treatment:
Drug: Insulin Lispro Mix25
Insulin Lispro Mix50
Experimental group
Description:
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Treatment:
Drug: Insulin Lispro Mix50

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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