A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
19. mars 2015 oppdatert av: AstraZeneca
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone.
The safety and tolerability of the three treatment regimens will also be compared.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
514
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Peoria, Arizona, Forente stater
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California
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Artesia, California, Forente stater
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Concord, California, Forente stater
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Encino, California, Forente stater
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Greenbrae, California, Forente stater
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La Mesa, California, Forente stater
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Orange, California, Forente stater
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Walnut Creek, California, Forente stater
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Whittier, California, Forente stater
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Colorado
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Colorado Springs, Colorado, Forente stater
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District of Columbia
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Washington, District of Columbia, Forente stater
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Florida
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Coral Gables, Florida, Forente stater
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Deland, Florida, Forente stater
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Melbourne, Florida, Forente stater
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Miami, Florida, Forente stater
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New Port Richey, Florida, Forente stater
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Georgia
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Decatur, Georgia, Forente stater
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Indiana
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Avon, Indiana, Forente stater
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Kansas
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Wichita, Kansas, Forente stater
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Kentucky
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Paducah, Kentucky, Forente stater
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Louisiana
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Baton Rouge, Louisiana, Forente stater
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New Orleans, Louisiana, Forente stater
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Maryland
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Oxon Hill, Maryland, Forente stater
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Massachusetts
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Boston, Massachusetts, Forente stater
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Michigan
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Chelsea, Michigan, Forente stater
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Ypsilanti, Michigan, Forente stater
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Minnesota
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St. Louis Park, Minnesota, Forente stater
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Missouri
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St. Louis, Missouri, Forente stater
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Montana
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Butte, Montana, Forente stater
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Nebraska
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Lincoln, Nebraska, Forente stater
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Nevada
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Las Vegas, Nevada, Forente stater
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New York
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New Hyde Park, New York, Forente stater
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New Windsor, New York, Forente stater
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New York, New York, Forente stater
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Rochester, New York, Forente stater
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North Carolina
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Durham, North Carolina, Forente stater
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Statesville, North Carolina, Forente stater
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Winston-Salem, North Carolina, Forente stater
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Ohio
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Athens, Ohio, Forente stater
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Cincinnati, Ohio, Forente stater
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Dayton, Ohio, Forente stater
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater
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South Dakota
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Rapid City, South Dakota, Forente stater
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Tennessee
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Memphis, Tennessee, Forente stater
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Texas
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Austin, Texas, Forente stater
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Dallas, Texas, Forente stater
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San Antonio, Texas, Forente stater
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Virginia
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Richmond, Virginia, Forente stater
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Washington
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Olympia, Washington, Forente stater
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Spokane, Washington, Forente stater
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Tacoma, Washington, Forente stater
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Bangalore, India
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Indore, India
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Karnal, India
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Mumbai, India
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Pune, India
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Toluca, Mexico
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Distrito Federal
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Mexico City, Distrito Federal, Mexico
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Jalisco
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Morelos
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Cuernavaca, Morelos, Mexico
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NuevoLeon
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Monterrey, NuevoLeon, Mexico
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Has been diagnosed with type 2 diabetes mellitus
- Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents
Exclusion Criteria:
- Has been previously exposed to exenatide once weekly
- Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
- Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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subkutan injeksjon, 2,0 mg, en gang i uken
oral tablet, once a day
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Aktiv komparator: 2
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oral tablet, 100mg, once a day
Andre navn:
subcutaneous injection, once a week
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Aktiv komparator: 3
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subcutaneous injection, once a week
oral tablet, 45mg, once a day
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in HbA1c From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
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Day 1, Week 26
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Tidsramme: Week 26
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Percentages of subjects achieving HbA1c target values of <7% at Week 26.
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Week 26
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Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Tidsramme: Week 26
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Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
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Week 26
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Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Tidsramme: Week 26
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Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
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Week 26
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Change in Body Weight From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in body weight from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting Plasma Glucose From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in fasting plasma glucose from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Systolic Blood Pressure From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in systolic blood pressure from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Diastolic Blood Pressure From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in diastolic blood pressure from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting Total Cholesterol From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in fasting total cholesterol from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Tidsramme: Day 1, Week 26
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Change in fasting HDL from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Ratio of Fasting Triglycerides at Week 26 to Baseline
Tidsramme: Day 1, Week 26
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Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1).
Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
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Day 1, Week 26
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Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Tidsramme: Day 1 to Week 26
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Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment.
Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
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Day 1 to Week 26
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
- Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.
- Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
- Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
- Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
- Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
- Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2008
Primær fullføring (Faktiske)
1. februar 2009
Studiet fullført (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først innsendt
6. mars 2008
Først innsendt som oppfylte QC-kriteriene
10. mars 2008
Først lagt ut (Anslag)
17. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehemmere
- Midler mot fedme
- Inkretiner
- Dipeptidyl-Peptidase IV-hemmere
- Pioglitazon
- Sitagliptinfosfat
- Exenatid
Andre studie-ID-numre
- BCB106 (DURATION - 2)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .