A Study in Adults With Type 1 Diabetes (ELEMENT 1)
3. Oktober 2014 aktualisiert von: Eli Lilly and Company
A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
536
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Brussels, Belgien, 1090
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Leuven, Belgien, 3000
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Liège, Belgien, 4000
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Fulda, Deutschland, 36037
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Hamburg, Deutschland, 22607
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Heidelberg, Deutschland, 69115
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St. Ingbert-Oberwürzbach, Deutschland, 66386
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Athens, Griechenland, 11527
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Haidari/Athens, Griechenland, 12462
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Thessaloniki, Griechenland, 56429
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Fukuoka, Japan, 815-8555
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Kanagawa, Japan, 235-0045
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Kumamoto, Japan, 862-0976
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Miyazaki, Japan, 880-0034
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Nagasaki, Japan, 857-1195
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Tokyo, Japan, 105-8471
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Guadalajara, Mexiko, 44600
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Monterrey, Mexiko, 64461
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Puebla, Mexiko, 72190
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Tampico, Mexiko, 89249
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Krakow, Polen, 31-530
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Lodz, Polen, 90-153
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Szczecin, Polen, 70-376
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Bucharest, Rumänien, 020359
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Galati, Rumänien, 800587
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Iasi, Rumänien, 700547
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Oradea, Rumänien, 410025
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Timisoara, Rumänien, 300182
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Budapest, Ungarn, 1134
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Debrecen, Ungarn, 4032
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Salgotarjan, Ungarn, 3100
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
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Florida
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Hollywood, Florida, Vereinigte Staaten, 33021
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New Port Richey, Florida, Vereinigte Staaten, 34652
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West Palm Beach, Florida, Vereinigte Staaten, 33401
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30303
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Roswell, Georgia, Vereinigte Staaten, 30076
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Illinois
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Springfield, Illinois, Vereinigte Staaten, 62704
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Iowa
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Des Moines, Iowa, Vereinigte Staaten, 50314
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Kansas
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Topeka, Kansas, Vereinigte Staaten, 66606
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40503
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Louisiana
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Metairie, Louisiana, Vereinigte Staaten, 70006
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Michigan
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Kalamazoo, Michigan, Vereinigte Staaten, 49048
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68131
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New Hampshire
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Nashua, New Hampshire, Vereinigte Staaten, 03063
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New York
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Mineola, New York, Vereinigte Staaten, 11501
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New Hyde Park, New York, Vereinigte Staaten, 11040
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Syracuse, New York, Vereinigte Staaten, 13210
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North Carolina
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Asheville, North Carolina, Vereinigte Staaten, 28803
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Texas
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Austin, Texas, Vereinigte Staaten, 78731
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Dallas, Texas, Vereinigte Staaten, 75390
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San Antonio, Texas, Vereinigte Staaten, 78229
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Have type 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]
- Have duration of diabetes greater than or equal to one year
- Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]
- Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
Exclusion Criteria:
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- Have significant renal, cardiac, gastrointestinal or liver disease
- Have active cancer or cancer within the past 5 years
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: LY2963016 + Insulin Lispro
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro.
Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
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Subkutan verabreicht
Administered subcutaneously
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Aktiver Komparator: Lantus + Insulin Lispro
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro.
Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
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Subkutan verabreicht
Administered subcutaneously
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
Zeitfenster: Baseline, Endpoint (up to 24 weeks)
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HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline, Endpoint (up to 24 weeks)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change From Baseline in Insulin Antibody Levels
Zeitfenster: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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Change From Baseline in Hemoglobin A1c (HbA1c)
Zeitfenster: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
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HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Zeitfenster: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours.
PP glucose is measured 2 hours (hrs) after the start of the meal.
Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit.
If only 1 of the 3 days of data was collected, then the value of the 1 day was used.
If only 2 of the 3 days of data were collected, then the average of the 2 days was used.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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Glycemic Variability of Fasting Blood Glucose
Zeitfenster: Baseline and Endpoints (up to 24 weeks and up 52 weeks)
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Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline and Endpoints (up to 24 weeks and up 52 weeks)
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Change From Baseline in Body Weight
Zeitfenster: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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Adult Low Blood Sugar Survey (ALBSS)
Zeitfenster: Baseline and 24 weeks and Endpoint (up to 52 weeks)
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ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always).
Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33.
Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72.
Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar.
Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline and 24 weeks and Endpoint (up to 52 weeks)
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Insulin Treatment Satisfaction Questionnaire (ITSQ)
Zeitfenster: Baseline and 24 weeks and Endpoint (up to 52 weeks)
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ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin.
Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes.
Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42].
ITSQ Total Overall Scores range from 22-154.
Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6].
Higher scores indicate better treatment satisfaction.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Baseline and 24 weeks and Endpoint (up to 52 weeks)
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Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])
Zeitfenster: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)].
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])
Zeitfenster: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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Units of insulin taken daily were presented.
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
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Endpoints [up to 24 weeks (wk) and up to 52 weeks]
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Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%
Zeitfenster: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period.
The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
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Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
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Incidence of Hypoglycemic Events
Zeitfenster: Baseline through 24 weeks (wk) and 52 weeks
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Incidence of hypoglycemic events is defined as the number of hypoglycemic events.
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].
Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event).
Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
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Baseline through 24 weeks (wk) and 52 weeks
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Rate Per 30 Days of Hypoglycemic Events
Zeitfenster: Baseline through 24 weeks (wk) and 52 weeks
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The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days.
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).
Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event).
Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
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Baseline through 24 weeks (wk) and 52 weeks
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Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2011
Primärer Abschluss (Tatsächlich)
1. August 2012
Studienabschluss (Tatsächlich)
1. April 2013
Studienanmeldedaten
Zuerst eingereicht
19. August 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. August 2011
Zuerst gepostet (Schätzen)
22. August 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
9. Oktober 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Oktober 2014
Zuletzt verifiziert
1. Oktober 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 13712
- I4L-MC-ABEB (Andere Kennung: Eli Lilly and Company)
- 2011-000829-73 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .