Clinical trial NCT02106364: A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint
timeFrame: Baseline, 26 Weeks
Secondary outcomes:
measure: Proportion of Participants with HbA1c ≤6.5% and <7.0%
timeFrame: Week 26 and Week 52
measure: Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event
timeFrame: Baseline through 26 Weeks and Baseline through 52 Weeks
measure: Rate of Total and Nocturnal Hypoglycemia Events
timeFrame: Baseline to 26 Weeks
measure: Fasting Serum Glucose (FSG) by Laboratory Measurements
timeFrame: 26 Weeks
measure: 9 Point Self Monitored Blood Glucose
timeFrame: 26 Weeks
measure: Change from Baseline in Body Weight at Week 26 Endpoint
timeFrame: Baseline, 26 Weeks
measure: Change from Baseline in HbA1c at 52 Week Endpoint
timeFrame: Baseline, Week 52
measure: Insulin Dose by Unit
timeFrame: 26 Weeks
measure: Time to Reach Steady-State
timeFrame: Baseline through 52 Weeks
measure: Fasting Blood Glucose by Self Monitoring
timeFrame: Baseline through 52 Weeks
measure: Intra-Participant Variability in Fasting Blood Glucose
timeFrame: Baseline through 52 Weeks
measure: Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score
timeFrame: Baseline, Week 26, Week 52
measure: Change from Baseline in the Low Blood Sugar Survey (LBSS)
timeFrame: Baseline, Week 26, Week 52
measure: Number of Participants Developing Anti-Insulin Peglispro Antibodies
timeFrame: Week 26 and Week 52
measure: Change from Baseline in Lipid Profile
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates PC
state: Alabama
city: Zephyrhills
country: United States
facility: Florida Medical Clinic PA
state: Florida
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Rehabilitation & Rheumatology, PC
state: New Mexico
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Dayton
country: United States
facility: STAT Research
state: Ohio
city: Kennewick
country: United States
facility: Apex Clinical Research
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: