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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02106364
• Other study ID #: 13564
• Secondary ID: I2R-MC-BIDB
• Status: Withdrawn
• Phase: Phase 3
• First received: April 3, 2014
• Last updated: March 25, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIndia: Ministry of HealthChina: Food and Drug AdministrationTaiwan : Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Peglispro
Administered SQ
• Insulin Glargine
Administered SQ

Locations

Country	Name	City	State
United States	Albuquerque Rehabilitation & Rheumatology, PC	Albuquerque	New Mexico
United States	Rheumatology Associates PC	Birmingham	Alabama
United States	STAT Research	Dayton	Ohio
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Diagnostic Rheumatology and Research	Indianapolis	Indiana
United States	Apex Clinical Research	Kennewick	Washington
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Heartland Research Associates	Wichita	Kansas
United States	Carolina Arthritis Associates	Wilmington	North Carolina
United States	Florida Medical Clinic PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint		Baseline, 26 Weeks	No
Secondary	Proportion of Participants with HbA1c =6.5% and <7.0%		Week 26 and Week 52	No
Secondary	Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event		Baseline through 26 Weeks and Baseline through 52 Weeks	No
Secondary	Rate of Total and Nocturnal Hypoglycemia Events		Baseline to 26 Weeks	Yes
Secondary	Fasting Serum Glucose (FSG) by Laboratory Measurements		26 Weeks	No
Secondary	9 Point Self Monitored Blood Glucose		26 Weeks	No
Secondary	Change from Baseline in Body Weight at Week 26 Endpoint		Baseline, 26 Weeks	No
Secondary	Change from Baseline in HbA1c at 52 Week Endpoint		Baseline, Week 52	No
Secondary	Insulin Dose by Unit		26 Weeks	No
Secondary	Time to Reach Steady-State		Baseline through 52 Weeks	No
Secondary	Fasting Blood Glucose by Self Monitoring		Baseline through 52 Weeks	No
Secondary	Intra-Participant Variability in Fasting Blood Glucose		Baseline through 52 Weeks	No
Secondary	Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score		Baseline, Week 26, Week 52	No
Secondary	Change from Baseline in the Low Blood Sugar Survey (LBSS)		Baseline, Week 26, Week 52	No
Secondary	Number of Participants Developing Anti-Insulin Peglispro Antibodies		Week 26 and Week 52	Yes
Secondary	Change from Baseline in Lipid Profile		Baseline, Week 26	No