- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00494013
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
4. November 2009 aktualisiert von: Eli Lilly and Company
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
442
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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Buenos Aires, Argentinien, C1188AAF
- 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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Ramos Mejia, Argentinien, B1704ETD
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Bangalore, Indien, 560052
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Chennai, Indien, 600086
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Cochin, Indien, 682026
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Mumbai, Indien, 400 067
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Pune, Indien, 411011
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Goyang-Si, Korea, Republik von, 410-719
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Sungnam-Si, Korea, Republik von, 463-712
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Chihuahua, Mexiko, 31238
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Guadalajara, Mexiko, 44340
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Krakow, Polen, 30-349
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Poznan, Polen, 61-495
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Rzeszow, Polen, 35-068
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Lugo, Spanien, 27004
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Palma de Mallorca, Spanien, 07014
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Santa Cruz de Tenerife, Spanien, 38320
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Valencia, Spanien, 46015
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Chiayi City, Taiwan, 600
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Neihu Taipei, Taiwan, 114
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Tainan, Taiwan, 704
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Taipei, Taiwan, 100
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Yung-Kang, Tainan, Taiwan, 710
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Budapest, Ungarn, H-1139
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Eger, Ungarn, 3300
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Mako, Ungarn, 6900
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Szekesfehervar, Ungarn, 8000
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Szekszard, Ungarn, 7100
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Veszprem, Ungarn, 8200
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Alabama
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Hueytown, Alabama, Vereinigte Staaten, 35023
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Arizona
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Litchfield Park, Arizona, Vereinigte Staaten, 85340
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Phoenix, Arizona, Vereinigte Staaten, 85016
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California
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Buena Park, California, Vereinigte Staaten, 90620
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Fountain Valley, California, Vereinigte Staaten, 92708
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Los Angeles, California, Vereinigte Staaten, 90057
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32257
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30312
- 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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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
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Indiana
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Evansville, Indiana, Vereinigte Staaten, 47714
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Indianapolis, Indiana, Vereinigte Staaten, 46202
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Newburgh, Indiana, Vereinigte Staaten, 47630
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40503
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Louisiana
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Slidell, Louisiana, Vereinigte Staaten, 70458
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Maryland
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Prince Frederick, Maryland, Vereinigte Staaten, 20678
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Michigan
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Novi, Michigan, Vereinigte Staaten, 48374
- 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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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89101
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New York
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Syracuse, New York, Vereinigte Staaten, 13210
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North Carolina
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Goldsboro, North Carolina, Vereinigte Staaten, 27530
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45236
- 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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London, Ohio, Vereinigte Staaten, 43140
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Oregon
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Bend, Oregon, Vereinigte Staaten, 97701
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Pennsylvania
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Lansdale, Pennsylvania, Vereinigte Staaten, 19446
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South Carolina
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Taylors, South Carolina, Vereinigte Staaten, 29687
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Tennessee
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Johnson City, Tennessee, Vereinigte Staaten, 37604
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Texas
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Grand Prairie, Texas, Vereinigte Staaten, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
- 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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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 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Exclusion Criteria
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
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: Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Andere Namen:
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Aktiver Komparator: Detemir
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Zeitfenster: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Zeitfenster: Baseline to 24 Weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
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Baseline to 24 Weeks
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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Zeitfenster: Baseline, 12 Weeks, 24 Weeks
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Baseline, 12 Weeks, 24 Weeks
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Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
Zeitfenster: 24 Weeks
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Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
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24 Weeks
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Glycemic Variability
Zeitfenster: 24 Weeks
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Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.
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24 Weeks
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7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Zeitfenster: 24 Weeks
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Actual daily mean blood glucose levels at endpoint.
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24 Weeks
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Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Zeitfenster: Baseline to 24 Weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Results are for the combined titration and maintenance periods.
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Baseline to 24 Weeks
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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Zeitfenster: Baseline to 24 Weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
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Baseline to 24 Weeks
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Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Zeitfenster: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Total Daily Insulin Dose (Units) at Endpoint
Zeitfenster: 24 Weeks
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Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
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24 Weeks
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Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
Zeitfenster: 24 Weeks
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Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
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24 Weeks
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Number of Injections of Basal Insulin Analog at Endpoint
Zeitfenster: 24 Weeks
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24 Weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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.
Allgemeine Veröffentlichungen
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
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 2007
Primärer Abschluss (Tatsächlich)
1. September 2008
Studienabschluss (Tatsächlich)
1. September 2008
Studienanmeldedaten
Zuerst eingereicht
27. Juni 2007
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. Juni 2007
Zuerst gepostet (Schätzen)
29. Juni 2007
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
11. November 2009
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. November 2009
Zuletzt verifiziert
1. November 2009
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Erkrankungen des endokrinen Systems
- Diabetes Mellitus
- Diabetes mellitus, Typ 2
- Hypoglykämische Mittel
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Gerinnungsmittel
- Heparin-Antagonisten
- Insulin Lispro
- Protamine
Andere Studien-ID-Nummern
- 10935 (DAIDS-ES)
- F3Z-MC-IOOY
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