Phase 1
Completed N=15
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01771250 ↗
Enrolled (actual)
15
Serious AEs
3.6%
Results posted
Mar 2019
Primary outcomePrimary: Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations — 0.27; 0.17 micromole per Liter (μmol/L)
Summary
This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations |
0.27; 0.17 | — |
| PRIMARY VLDL-TG Secretion Rate |
38.79; 25.61 | — |
| PRIMARY VLDL-TG Oxidation Rate |
20.13; 15.34 | — |
| PRIMARY VLDL-TG Clearance Rate |
142.16; 155.11 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
- Otherwise fit and healthy
- Non smoker
Exclusion Criteria
- Taking medication or supplements other than insulin to control diabetes.
- Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
Data sourced from ClinicalTrials.gov (NCT01771250). 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.