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

Phase 3

Conditions: Patients with Type 2 Diabetes Mellitus

Registration Number: CTRI/2014/09/005054

Lead Sponsor: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 663

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 percent to 11.0 percent, inclusive, according to central lab at screening.
Have body mass index (BMI) greater than equal to 40 kilogram/square meter (kg/m2).
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 â‰¥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 -Are using lipid-lowering medication at a dose that has not been stable for â‰¥90 days prior to screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint	Time Frame: Baseline, 26 Weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants with HbA1c greater than equal to 6.5 percent and greater than 7.0 percent	Time Frame: Week 26 and Week 52
Change from Baseline in Body Weight at Week 26 Endpoint	Time Frame: Baseline, 26 Weeks
Proportion of Participants with HbA1c greater than 7.0 percent Without Nocturnal Hypoglycemia Event	Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks
Rate of Total and Nocturnal Hypoglycemia Events	Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks
Time to Reach Steady-State	Time Frame: Baseline through 52 Weeks
Fasting Serum Glucose (FSG) by Laboratory Measurements	Time Frame: 26 Weeks
9 Point Self Monitored Blood Glucose	Time Frame: 26 Weeks
Insulin Dose by Unit	Time Frame: 26 Weeks
Change from Baseline in HbA1c at 52 Week Endpoint	Time Frame: Baseline, Week 52
Fasting Blood Glucose by Self Monitoring	Time Frame: Baseline through 52 Weeks
Intra-Participant Variability in Fasting Blood Glucose	Time Frame: Baseline through 52 Weeks
Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score	Time Frame: Baseline, Week 26, Week 52
Change from Baseline in the Low Blood Sugar Survey (LBSS)	Time Frame: Baseline, Week 26, Week 52
Number of Participants Developing Anti-Insulin Peglispro Antibodies	Time Frame: Week 26 and Week 52
Change from Baseline in Lipid Profile	Time Frame: Baseline, Week 26

Trial Locations

Locations (6): AMRITA Institute of Medical Sciences and Research Centre
🇮🇳
Ernakulam, KERALA, India
Apollo Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
KEM Hospital & Research Centre
🇮🇳
Pune, MAHARASHTRA, India
KLES Dr.Prabhakar Kore Hos, J.N.Medical College
🇮🇳
Belgaum, KARNATAKA, India
St. John Medical College & Hospital
🇮🇳
Bangalore, KARNATAKA, India
Topiwala National Medical College & BYL Nair Ch. Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
AMRITA Institute of Medical Sciences and Research Centre
🇮🇳Ernakulam, KERALA, India
Harish Kumar
Principal investigator
9446742989
harishkumar@aims.amrita.edu