Comparison of Insulin Mix25 Versus Mix50

NCT ID: NCT01773473

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-08-31

Brief 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).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Lispro Mix25

Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.

Group Type: EXPERIMENTAL

Insulin Lispro Mix25

Intervention Type: DRUG

Administered SC

Insulin Lispro Mix50

Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Group Type: EXPERIMENTAL

Insulin Lispro Mix50

Intervention Type: DRUG

Administered SC

Interventions

Insulin Lispro Mix25

Administered SC

Intervention Type: DRUG

Insulin Lispro Mix50

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY275585-75; LY275585-50

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Beijing, , China

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Changsha, , China

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Chengdu, , China

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Chongqing, , China

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Nanjing, , China

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Shanghai, , China

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Ürümqi, , China

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Zhengzhou, , China

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Ibaraki, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Yamaguchi, , Japan

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Daejeon, , South Korea

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Incheon, , South Korea

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Jeju Special Self-Governing Pr, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

Countries

China; Japan; South Korea; Turkey (Türkiye)

References

Su Q, Liu J, Li P, Qian L, Yang W. Relative Contribution of Fasting and Postprandial Blood Glucose in Overall Glycemic Control: Post Hoc Analysis of a Phase IV Randomized Trial. Diabetes Ther. 2018 Jun;9(3):987-999. doi: 10.1007/s13300-018-0403-7. Epub 2018 Mar 24.

Reference Type: DERIVED

PMID: 29574635 (View on PubMed)

Other Identifiers

F3Z-CR-IOQI

Identifier Type: OTHER

Identifier Source: secondary_id

14675

Identifier Type: -

Identifier Source: org_study_id