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

3 oktober 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Neuss, Duitsland, 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.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: LY2963016
Single 0.3 U/kg dose administered subcutaneously
Actieve vergelijker: Lantus
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Geneesmiddel: Lantus
Single 0.3 U/kg dose administered subcutaneously

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum Glucose Infusion Rate (Rmax)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2012

Primaire voltooiing (Werkelijk)

1 juli 2012

Studie voltooiing (Werkelijk)

1 juli 2012

Studieregistratiedata

Eerst ingediend

15 mei 2012

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2012

Eerst geplaatst (Schatting)

17 mei 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

7 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

3 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 13831
  • I4L-MC-ABEE (Andere identificatie: Eli Lilly and Company)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 1

Klinische onderzoeken op LY2963016

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