- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00729326
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
20. März 2015 aktualisiert von: AstraZeneca
Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
83
Phase
- Phase 4
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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Texas
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San Antonio, Texas, Vereinigte Staaten
- Research Site
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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 bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Have type 2 diabetes
- Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
- Have a fasting glucose concentration <280 mg/dL at Visit 1
- Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
- Are between 18 and 70 years of age, inclusive.
- Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
- Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
- Can swallow oral study drug capsule, without splitting or crushing.
Exclusion Criteria:
Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- Are breastfeeding.
- Test positive for pregnancy at the time of screening.
- Intend to become pregnant during the study.
- Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
Treated with any of the following medications:
- Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
- Alpha-glucosidase inhibitor within 2 months of screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
- Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
- Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have had organ transplantation.
- Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Folge A
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subkutane Injektion (5 µg oder 10 µg), zweimal täglich
Andere Namen:
orale Verabreichung (100 mg), einmal täglich morgens
Andere Namen:
subcutaneous injection (5mcg or 10mcg), twice a day
oral administration (100mg), once a day in the morning
|
Experimental: Folge B
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subkutane Injektion (5 µg oder 10 µg), zweimal täglich
Andere Namen:
orale Verabreichung (100 mg), einmal täglich morgens
Andere Namen:
subcutaneous injection (5mcg or 10mcg), twice a day
oral administration (100mg), once a day in the morning
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Time-averaged Glucose During a 24 Hour Period
Zeitfenster: baseline and 8 Weeks
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Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
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baseline and 8 Weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Two-hour Postprandial Glucose After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Fasting Blood Glucose After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
|
baseline and 8 Weeks
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Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Triglyceride AUC After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial C-peptide AUC After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Insulin AUC After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Insulin AUC Excursion After the Morning Meal
Zeitfenster: baseline and 8 Weeks
|
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Active GLP-1 AUC After the Morning Meal
Zeitfenster: baseline and 8 Weeks
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Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
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baseline and 8 Weeks
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Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Zeitfenster: baseline and 8 Weeks
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Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
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baseline and 8 Weeks
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Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Zeitfenster: 4 Weeks
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Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
|
4 Weeks
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Episodes of Hypoglycemia (Baseline to Week 4)
Zeitfenster: 4 weeks
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Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
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4 weeks
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Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Zeitfenster: 8 weeks
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Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
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8 weeks
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Episodes of Hypoglycemia (Week 4 to Week 8)
Zeitfenster: 8 weeks
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Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
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8 weeks
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Percentage of Patients Experiencing Hypoglycemia (Overall)
Zeitfenster: 4 weeks and 8 weeks
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Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
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4 weeks and 8 weeks
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Episodes of Hypoglycemia (Overall)
Zeitfenster: 4 weeks and 8 weeks
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Number of episodes of hypoglycemia experienced overall during the study
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4 weeks and 8 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
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 2008
Primärer Abschluss (Tatsächlich)
1. Oktober 2009
Studienabschluss (Tatsächlich)
1. Oktober 2009
Studienanmeldedaten
Zuerst eingereicht
4. August 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. August 2008
Zuerst gepostet (Schätzen)
7. August 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
9. April 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. März 2015
Zuletzt verifiziert
1. März 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
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
- Enzym-Inhibitoren
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Protease-Inhibitoren
- Mittel gegen Fettleibigkeit
- Inkretine
- Dipeptidyl-Peptidase IV-Inhibitoren
- Sitagliptinphosphat
- Exenatide
Andere Studien-ID-Nummern
- H8O-US-GWCV
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 .
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