Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01773473
First received: January 18, 2013
Last updated: May 4, 2015
Last verified: May 2015
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin Lispro Mix25
Drug: Insulin Lispro Mix50
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.


Secondary Outcome Measures:
  • Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26 [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: No ]
    HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.

  • Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.

  • Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.

  • Number of Hypoglycemic Events Baseline Through Week 26 (Incidence) [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: Yes ]
    A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].

  • Insulin Dose at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Insulin dose is the total daily dose including basal and prandial doses.

  • Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.


Enrollment: 403
Study Start Date: January 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Lispro Mix25
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
Drug: Insulin Lispro Mix25
Administered SC
Other Name: LY275585-75
Experimental: Insulin Lispro Mix50
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Drug: Insulin Lispro Mix50
Administered SC
Other Name: LY275585-50

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773473

Locations
China
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Beijing, China, 100029
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Changsha, China, 410013
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Chengdu, China, 610041
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Chongqing, China, 404000
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Nanjing, China, 210028
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Shanghai, China, 200092
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Wulumuqi, China, 830000
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Zhengzhou, China, 450052
Japan
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Ibaraki, Japan, 302-0118
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Kagoshima, Japan, 895-0052
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Kanagawa, Japan, 242-0004
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Miyagi, Japan, 985-0835
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Nagano, Japan, 399-0006
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Okayama, Japan, 700-0013
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Osaka, Japan, 530-0001
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Saitama, Japan, 350-1305
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Tochigi, Japan, 329-0433
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Tokyo, Japan, 206-0633
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Yamaguchi, Japan, 751-0815
Korea, Republic of
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Daejeon, Korea, Republic of, 302-799
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Incheon, Korea, Republic of, 403-720
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Jeju Special Self-Governing Pr, Korea, Republic of, 690-767
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Seoul, Korea, Republic of, 137-701
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Suwon, Korea, Republic of, 442-723
Turkey
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Ankara, Turkey, 06500
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Antalya, Turkey, 07070
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Gaziantep, Turkey, 27070
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01773473     History of Changes
Other Study ID Numbers: 14675, F3Z-CR-IOQI
Study First Received: January 18, 2013
Results First Received: May 4, 2015
Last Updated: May 4, 2015
Health Authority: Japan: Institutional Review Board
South Korea: Institutional Review Board
China: Ethics Committee
Turkey: Ministry of Health
India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2015