Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

This study is currently recruiting participants.
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01773473
First received: January 18, 2013
Last updated: March 14, 2014
Last verified: March 2014

January 18, 2013
March 14, 2014
January 2013
August 2014   (final data collection date for primary outcome measure)
Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01773473 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving HbA1c of <7% or ≤6.5% at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Serum Glucose at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Number of Hypoglycemic Events at 26 Weeks (Incidence) [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
  • Insulin Dose at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 1,5-Anhydroglucitol (1,5-AG) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Insulin Mix25 Versus Mix50
Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Insulin Lispro Mix25
    Administered SC
    Other Name: LY275585-75
  • Drug: Insulin Lispro Mix50
    Administered SC
    Other Name: LY275585-50
  • Experimental: Insulin Lispro Mix25
    Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
    Intervention: Drug: Insulin Lispro Mix25
  • Experimental: Insulin Lispro Mix50
    Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
    Intervention: Drug: Insulin Lispro Mix50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
China,   Japan,   Korea, Republic of,   Turkey
 
NCT01773473
14675, F3Z-CR-IOQI
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP