Phase 1
Completed N=24
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
Source: ClinicalTrials.gov NCT02197520 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value) — 59.09; 55.52; 17.22; 19.67 milligram*hour per deciliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value) |
59.09; 55.52; 17.22; 19.67 | — |
| SECONDARY Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro |
437.78; 398.26; 334.23; 343.54; 244.68; 239.83 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro |
839; 835 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen |
33700; 35700 | — |
| SECONDARY Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29 |
25.7; 38.6; 30.2; 34.4; 41.5; 51.4 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp |
— | — |
Eligibility Criteria
Inclusion Criteria
- Stable glycated hemoglobin (HbA1c) less 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
Data sourced from ClinicalTrials.gov (NCT02197520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.