Overview

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

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Globin Zinc
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