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A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

3 ottobre 2014 aggiornato da: Eli Lilly and Company

Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus

The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Neuss, Germania, 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.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
  • have had a duration of diabetes ≥1 year
  • have hemoglobin A1c ≤10.0%
  • have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
  • have a body mass index ≤29 kilograms per square meter (kg/m²)
  • have venous access sufficient to allow blood sampling and cannulation for clamp procedures

Exclusion Criteria:

  • are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
  • have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
  • have a history of proliferative retinopathy
  • have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
  • have an electrocardiogram (ECG) reading considered outside the normal limits
  • have an abnormal blood pressure
  • have abnormal clinical laboratory tests
  • have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
  • show evidence of significant active neuropsychiatric disease
  • regular use of known drugs of abuse and/or show positive findings on drug screening
  • show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
  • show evidence of hepatitis C and/or positive hepatitis C antibody
  • show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • are women with a positive pregnancy test or women who are lactating
  • have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
  • had more than 1 episode of severe hypoglycemia within 6 months prior to study
  • undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
  • had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
  • are receiving systemic glucocorticoid therapy
  • have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
  • show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
  • smoke more than 10 cigarettes (or equivalent other tobacco products) per day

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LY2963016
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
Single 0.3 U/kg dose administered subcutaneously
Comparatore attivo: Lantus
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Single 0.3 U/kg dose administered subcutaneously

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
Periods 1 and 2: Baseline up to 42 hours postdose

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum Glucose Infusion Rate (Rmax)
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.
Periods 1 and 2: Baseline up to 42 hours postdose
Total Glucose Infused (Gtot)
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.
Periods 1 and 2: Baseline up to 42 hours postdose
Time of Maximum Glucose Infusion Rate (tRmax)
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
Lasso di tempo: Periods 1 and 2: Baseline up to 42 hours postdose
AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Periods 1 and 2: Baseline up to 42 hours postdose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2012

Completamento primario (Effettivo)

1 luglio 2012

Completamento dello studio (Effettivo)

1 luglio 2012

Date di iscrizione allo studio

Primo inviato

15 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2012

Primo Inserito (Stima)

17 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 ottobre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 ottobre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su LY2963016

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