Phase 1
Completed N=27
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
Source: ClinicalTrials.gov NCT01925989 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM) — 0.822; 0.846 ratio
Summary
This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM) |
0.822; 0.846 | — |
| SECONDARY Lipid Oxidation in T1DM and Healthy Participants |
0.892; 0.900; 0.906 | — |
| SECONDARY Basal Metabolic Rate (BMR) for T1DM |
1511.0; 1403.6 | — |
| SECONDARY Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants |
0.848 | — |
| SECONDARY Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants |
22; 8; 4.5 | — |
| SECONDARY Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM |
0.836; 0.874 | — |
Eligibility Criteria
Inclusion Criteria
Type 1 Diabetics:
- T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%
All Participants:
- Otherwise fit and healthy
- Non smoker
Exclusion Criteria
Type 1 Diabetics:
- 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
All Participants:
- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
Data sourced from ClinicalTrials.gov (NCT01925989). 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.