Status:
COMPLETED
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02197520
Start Date
July 1 2014
End Date
June 1 2015
Last Update
November 1 2018
Active Locations (1)
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1
Profil Institute for Clinical Research Inc
Chula Vista, California, United States, 91911