Phase 1
Completed N=25
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01769404 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Concentration of Epinephrine — 157.2; 196.5; 607.5; 525.2 picomole per liter (pmol/L)
Summary
This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Epinephrine |
157.2; 196.5; 607.5; 525.2 | — |
| SECONDARY Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL |
11600; 12700 | — |
| SECONDARY Amount of Glucose Required to Maintain BG of 72 mg/dL |
15400; 15900 | — |
| SECONDARY Concentration of Cortisol |
206.7; 260.0; 337.3; 333.8 | — |
| SECONDARY Concentration of Glucagon |
8.02; 5.28; 5.89; 4.98 | — |
| SECONDARY Concentration of Growth Hormone |
1.0816; 1.3948; 6.8752; 8.0114 | — |
| SECONDARY Concentration of Norepinephrine |
1004.2; 1139.8; 1235.8; 1434.8 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%
- Otherwise fit and healthy
- Nonsmoker
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 has poor awareness of hypoglycemia
Data sourced from ClinicalTrials.gov (NCT01769404). 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.