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 |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/3/2018 |
| Start Date: | July 2014 |
| End Date: | June 2015 |
The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus
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.
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.
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
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