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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02106364
Recruitment Status : Withdrawn (Lilly's decision to cancel this trial is due to regulatory uncertainty in China.)
First Posted : April 8, 2014
Last Update Posted : March 28, 2016
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Peglispro Drug: Insulin Glargine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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 Name: 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

Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint [ Time Frame: Baseline, 26 Weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02106364

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

Responsible Party: Eli Lilly and Company Identifier: NCT02106364     History of Changes
Other Study ID Numbers: 13564
I2R-MC-BIDB ( Other Identifier: Eli Lilly and Company )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

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