A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics

NCT ID: NCT02197520

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

Brief Summary

This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insulin Peglispro (with Insulin Lispro)

Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Group Type: EXPERIMENTAL

Insulin Peglispro

Intervention Type: DRUG

Administered subcutaneously (SC), (U-100 formulation)

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC), (U-100 formulation)

Insulin Glargine (with Insulin Lispro)

Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: DRUG

Administered subcutaneously (SC), (U-100 formulation)

Insulin Lispro

Intervention Type: DRUG

Administered subcutaneously (SC), (U-100 formulation)

Interventions

Insulin Peglispro

Administered subcutaneously (SC), (U-100 formulation)

Intervention Type: DRUG

Insulin Glargine

Administered subcutaneously (SC), (U-100 formulation)

Intervention Type: DRUG

Insulin Lispro

Administered subcutaneously (SC), (U-100 formulation)

Intervention Type: DRUG

Other Intervention Names

LY2605541

Eligibility Criteria

Inclusion Criteria

• Stable glycated hemoglobin (HbA1c) less than (<) 10.0 percent (%)
• Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (U/kg)
• C-peptide <0.3 nanomole per liter (nmol/L)
• Stable body during the last 2 months

Exclusion Criteria

• Corrected QT interval (QTc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
• Abnormal blood pressure
• A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
• Fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
• Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
• Currently receive insulin by pump or insulin degludec
• Poorly controlled diabetes or known to have poor awareness of hypoglycemia
• History of gastroparesis or gastrointestinal malabsorption
• Require treatment with any drug other than insulin to treat diabetes
• Previous history of proliferative retinopathy
• Excessive consumers of xanthines

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Profil Institute for Clinical Research Inc

Chula Vista, California, United States

Countries

United States

Other Identifiers

I2R-MC-BIDV

Identifier Type: OTHER

Identifier Source: secondary_id

15407

Identifier Type: -

Identifier Source: org_study_id