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

NCT02106364 | Withdrawn Phase 3 DMC

• 2 other identifiers: 13564I2R-MC-BIDB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint

  Baseline, 26 Weeks

Secondary Outcomes (15)

• 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

Study Arms (2)

LY2605541

EXPERIMENTAL

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

Insulin Glargine

ACTIVE COMPARATOR

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

Interventions

Insulin Peglispro DRUG

Administered SQ

Also known as: LY2605541

LY2605541

Insulin Glargine DRUG

Administered SQ

Insulin Glargine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (10)

Rheumatology Associates PC

Birmingham, Alabama, 35205, United States

Location

Florida Medical Clinic PA

Zephyrhills, Florida, 33542-7505, United States

Location

Diagnostic Rheumatology and Research

Indianapolis, Indiana, 46227, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Albuquerque Rehabilitation & Rheumatology, PC

Albuquerque, New Mexico, 87102, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28602, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, United States

Location

STAT Research

Dayton, Ohio, 45417, United States

Location

Apex Clinical Research

Kennewick, Washington, 99336, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

basal insulin peglispro; LY2605541; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

US (10)