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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Lispro; Drug: Insulin Peglispro; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197520

15407

I2R-MC-BIDV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Insulin Peglispro (with Insulin Lispro)

Experimental group

Description:

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

Treatment:

Drug: Insulin Peglispro

Drug: Insulin Lispro

Insulin Glargine (with Insulin Lispro)

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Glargine

Drug: Insulin Lispro