Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01773473
First received: January 18, 2013
Last updated: May 1, 2014
Last verified: May 2014
  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 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated 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 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
  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
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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
Last Updated: May 1, 2014
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 October 23, 2014