A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
27 mars 2019 uppdaterad av: Eli Lilly and Company
Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Neuss, Tyskland, 41460
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: LY2605541
Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods.
Dose based on prestudy basal insulin dosing regimen.
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Aktiv komparator: Insulin Glargine
Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods.
Dose based on prestudy basal insulin dosing regimen.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Concentration of Epinephrine
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Epinephrine levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Amount of Glucose Required to Maintain BG of 72 mg/dL
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Cortisol
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Cortisol levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Glucagon
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Glucagon levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Growth Hormone
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Growth hormone levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Norepinephrine
Tidsram: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Norepinephrine values are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2013
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
14 januari 2013
Först inskickad som uppfyllde QC-kriterierna
14 januari 2013
Första postat (Uppskatta)
16 januari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14870
- I2R-MC-BIDM (Annan identifierare: Eli Lilly and Company)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .