Phase 1 N=15 Randomized Other

A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT01771250 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Mar 2019

Primary outcome: Primary: Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations — 0.27; 0.17 micromole per Liter (μmol/L)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Insulin Peglispro (Biological); Insulin Glargine (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Dec 2014

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	—

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.

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

View full record on ClinicalTrials.gov →

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.