A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus

A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naïve Patients With Type 2 Diabetes Mellitus: An Open-Label, Randomized, 52-week Study

The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM). Both drugs will be given by an injection under the skin. Participants may continue to take oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal physician. The study is expected to last about 12 months for each participant.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin Peglispro

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Rheumatology Associates PC
  • Florida
    • Zephyrhills, Florida, United States, 33542-7505
      • Florida Medical Clinic PA
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Diagnostic Rheumatology and Research
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Rehabilitation & Rheumatology, PC
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • STAT Research
  • Washington
    • Kennewick, Washington, United States, 99336
      • Apex Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have T2DM (per World Health Organization [WHO] Classification of Diabetes) not treated with insulin.
• Have had diabetes for at least 1 year.
• Have been receiving at least 2 oral antihyperglycemic medications (OAMs) for at least 3 months prior to the study.
• Have hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central lab at screening.
• Have body mass index (BMI) ≤40 kilogram/square meter (kg/m^2).
• This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only: are not breastfeeding, test negative for a serum pregnancy test, intend not to become pregnant during study or willing to have a reliable method of birth control.

Exclusion Criteria:

• Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any duration during pregnancy is not considered an exclusion criterion.
• Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 3 months prior to screening.
• Local OAM restrictions: for participants on OAMs, restrictions for cardiac, renal, hepatic diseases and maximum dose, local product regulations must apply.
• Weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss.
• Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
• Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of DKA or hyperosmolar state/coma in the past 6 months.
• Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification).
• Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2 milligram/deciliter (mg/dL) (177 micromole/liter [mol/L]).
• Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements.

• Lipid-lowering medications:

  • Are using niacin preparations as a lipid-lowering medication or bile acid sequestrants within 90 days prior to screening; or,
  • Are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2605541; LY2605541 administered by subcutaneous (SQ) injection once daily for 52 weeks. Initial dose is 10 units (10 U) and is titrated by investigator. Participants may continue oral antihyperglycemic medication (OAM) as prescribed by their personal physician.	Drug: Insulin Peglispro; Administered SQ; Other Names: LY2605541
Active Comparator: Insulin Glargine; Insulin glargine administered by SQ injection once daily for 52 weeks. Initial dose is 10 U and is titrated by investigator. Participants may continue OAM as prescribed by their personal physician.	Drug: Insulin Glargine; Administered SQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint	Baseline, 26 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants with HbA1c ≤6.5% and <7.0%	Week 26 and Week 52
Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event	Baseline through 26 Weeks and Baseline through 52 Weeks
Rate of Total and Nocturnal Hypoglycemia Events	Baseline to 26 Weeks
Fasting Serum Glucose (FSG) by Laboratory Measurements	26 Weeks
9 Point Self Monitored Blood Glucose	26 Weeks
Change from Baseline in Body Weight at Week 26 Endpoint	Baseline, 26 Weeks
Change from Baseline in HbA1c at 52 Week Endpoint	Baseline, Week 52
Insulin Dose by Unit	26 Weeks
Time to Reach Steady-State	Baseline through 52 Weeks
Fasting Blood Glucose by Self Monitoring	Baseline through 52 Weeks
Intra-Participant Variability in Fasting Blood Glucose	Baseline through 52 Weeks
Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score	Baseline, Week 26, Week 52
Change from Baseline in the Low Blood Sugar Survey (LBSS)	Baseline, Week 26, Week 52
Number of Participants Developing Anti-Insulin Peglispro Antibodies	Week 26 and Week 52
Change from Baseline in Lipid Profile	Baseline, Week 26

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: March 25, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: 13564; I2R-MC-BIDB (Other Identifier: Eli Lilly and Company)