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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
514
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Peoria, Arizona, Förenta staterna
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California
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Artesia, California, Förenta staterna
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Concord, California, Förenta staterna
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Encino, California, Förenta staterna
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Greenbrae, California, Förenta staterna
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La Mesa, California, Förenta staterna
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Orange, California, Förenta staterna
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Walnut Creek, California, Förenta staterna
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Whittier, California, Förenta staterna
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Colorado
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Colorado Springs, Colorado, Förenta staterna
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District of Columbia
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Washington, District of Columbia, Förenta staterna
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Florida
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Coral Gables, Florida, Förenta staterna
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Deland, Florida, Förenta staterna
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Melbourne, Florida, Förenta staterna
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Miami, Florida, Förenta staterna
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New Port Richey, Florida, Förenta staterna
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Georgia
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Decatur, Georgia, Förenta staterna
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Indiana
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Avon, Indiana, Förenta staterna
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Kansas
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Wichita, Kansas, Förenta staterna
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Kentucky
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Paducah, Kentucky, Förenta staterna
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna
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New Orleans, Louisiana, Förenta staterna
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Maryland
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Oxon Hill, Maryland, Förenta staterna
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Massachusetts
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Boston, Massachusetts, Förenta staterna
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Michigan
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Chelsea, Michigan, Förenta staterna
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Ypsilanti, Michigan, Förenta staterna
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Minnesota
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St. Louis Park, Minnesota, Förenta staterna
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Missouri
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St. Louis, Missouri, Förenta staterna
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Montana
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Butte, Montana, Förenta staterna
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Nebraska
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Lincoln, Nebraska, Förenta staterna
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Nevada
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Las Vegas, Nevada, Förenta staterna
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New York
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New Hyde Park, New York, Förenta staterna
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New Windsor, New York, Förenta staterna
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New York, New York, Förenta staterna
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Rochester, New York, Förenta staterna
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North Carolina
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Durham, North Carolina, Förenta staterna
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Statesville, North Carolina, Förenta staterna
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Winston-Salem, North Carolina, Förenta staterna
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Ohio
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Athens, Ohio, Förenta staterna
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Cincinnati, Ohio, Förenta staterna
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Dayton, Ohio, Förenta staterna
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna
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South Dakota
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Rapid City, South Dakota, Förenta staterna
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Tennessee
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Memphis, Tennessee, Förenta staterna
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Texas
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Austin, Texas, Förenta staterna
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Dallas, Texas, Förenta staterna
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San Antonio, Texas, Förenta staterna
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Virginia
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Richmond, Virginia, Förenta staterna
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Washington
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Olympia, Washington, Förenta staterna
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Spokane, Washington, Förenta staterna
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Tacoma, Washington, Förenta staterna
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Bangalore, Indien
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Indore, Indien
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Karnal, Indien
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Mumbai, Indien
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Pune, Indien
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Toluca, Mexiko
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Distrito Federal
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Mexico City, Distrito Federal, Mexiko
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Jalisco
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Guadalajara, Jalisco, Mexiko
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Zapopan, Jalisco, Mexiko
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Morelos
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Cuernavaca, Morelos, Mexiko
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NuevoLeon
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Monterrey, NuevoLeon, Mexiko
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 1
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subkutan injektion, 2,0 mg, en gång i veckan
oral tablet, once a day
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Aktiv komparator: 2
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oral tablet, 100mg, once a day
Andra namn:
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in HbA1c From Baseline to Week 26
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2008
Primärt slutförande (Faktisk)
1 februari 2009
Avslutad studie (Faktisk)
1 juli 2009
Studieregistreringsdatum
Först inskickad
6 mars 2008
Först inskickad som uppfyllde QC-kriterierna
10 mars 2008
Första postat (Uppskatta)
17 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 mars 2015
Senast verifierad
1 mars 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabetes mellitus, typ 2
- Hypoglykemiska medel
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Proteashämmare
- Medel mot fetma
- Inkretiner
- Dipeptidyl-Peptidas IV-hämmare
- Pioglitazon
- Sitagliptinfosfat
- Exenatid
Andra studie-ID-nummer
- BCB106 (DURATION - 2)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .