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

This study has been withdrawn prior to enrollment.
(Lilly's decision to cancel this trial is due to regulatory uncertainty in China.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02106364
First received: April 3, 2014
Last updated: March 25, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Peglispro
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 Week Endpoint [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants with HbA1c ≤6.5% and <7.0% [ Time Frame: Week 26 and Week 52 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Rate of Total and Nocturnal Hypoglycemia Events [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: Yes ]
  • Fasting Serum Glucose (FSG) by Laboratory Measurements [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • 9 Point Self Monitored Blood Glucose [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at Week 26 Endpoint [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in HbA1c at 52 Week Endpoint [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Insulin Dose by Unit [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Time to Reach Steady-State [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose by Self Monitoring [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Intra-Participant Variability in Fasting Blood Glucose [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Low Blood Sugar Survey (LBSS) [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants Developing Anti-Insulin Peglispro Antibodies [ Time Frame: Week 26 and Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Lipid Profile [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT02106364

Locations
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
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02106364     History of Changes
Other Study ID Numbers: 13564  I2R-MC-BIDB 
Study First Received: April 3, 2014
Last Updated: March 25, 2016
Health Authority: Israel: Ethics Commission
India: Ministry of Health
China: Food and Drug Administration
Taiwan : Food and Drug Administration
South Africa: Medicines Control Council

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

ClinicalTrials.gov processed this record on December 09, 2016