A Study in Participants With Type 2 Diabetes Mellitus (AWARD-1)
15. Januar 2015 aktualisiert von: Eli Lilly and Company
A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes.
The participants must also be taking metformin and pioglitazone.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
During the study, if a participant developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, the participant received additional therapeutic intervention or initiation of an alternative antihyperglycemic medication following study drug discontinuation (rescue therapy).
Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified analyses.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
978
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, CBA 1419
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Guadalajara, Mexiko, 44600
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Mexico City, Mexiko, 6700
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Monterrey, Mexiko, 64461
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Caguas, Puerto Rico, 00726
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Hato Rey, Puerto Rico, 00917
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Manati, Puerto Rico, 00674
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Ponce, Puerto Rico, 00716
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San German, Puerto Rico, 00683
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San Juan, Puerto Rico, 00907
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Yabucoa, Puerto Rico, 00767
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Arizona
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Goodyear, Arizona, Vereinigte Staaten, 85395
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Phoenix, Arizona, Vereinigte Staaten, 85028
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California
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Cathedral City, California, Vereinigte Staaten, 92234
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Concord, California, Vereinigte Staaten, 94520
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Fresno, California, Vereinigte Staaten, 93720
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Greenbrae, California, Vereinigte Staaten, 94904
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Lancaster, California, Vereinigte Staaten, 93534
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Mission Hills, California, Vereinigte Staaten, 91345
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Monterey, California, Vereinigte Staaten, 93940
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National City, California, Vereinigte Staaten, 91950
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Oceanside, California, Vereinigte Staaten, 92056
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Paramount, California, Vereinigte Staaten, 90723
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Roseville, California, Vereinigte Staaten, 95661
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San Ramon, California, Vereinigte Staaten, 94583
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Tustin, California, Vereinigte Staaten, 92780
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Connecticut
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New Britain, Connecticut, Vereinigte Staaten, 06050
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Florida
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Fort Lauderdale, Florida, Vereinigte Staaten, 33316
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Hollywood, Florida, Vereinigte Staaten, 33021
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Orlando, Florida, Vereinigte Staaten, 32806
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Pembroke Pines, Florida, Vereinigte Staaten, 33027
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West Palm Beach, Florida, Vereinigte Staaten, 33401
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96813
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Idaho
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Boise, Idaho, Vereinigte Staaten, 83702
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Idaho Falls, Idaho, Vereinigte Staaten, 83404
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Meridian, Idaho, Vereinigte Staaten, 83646
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Illinois
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Crystal Lake, Illinois, Vereinigte Staaten, 60012
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Peoria, Illinois, Vereinigte Staaten, 61615
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Indiana
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Vincennes, Indiana, Vereinigte Staaten, 47591
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Kansas
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Topeka, Kansas, Vereinigte Staaten, 66606
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Kentucky
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Madisonville, Kentucky, Vereinigte Staaten, 42431
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
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Maine
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Bangor, Maine, Vereinigte Staaten, 04401
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Biddeford, Maine, Vereinigte Staaten, 04005
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Maryland
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Elkridge, Maryland, Vereinigte Staaten, 21075
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Michigan
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Bloomfield Hills, Michigan, Vereinigte Staaten, 48302
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Flint, Michigan, Vereinigte Staaten, 48503
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63141
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New Hampshire
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Nashua, New Hampshire, Vereinigte Staaten, 03063
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New Jersey
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Toms River, New Jersey, Vereinigte Staaten, 08753
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New York
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Albany, New York, Vereinigte Staaten, 12206
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Flushing, New York, Vereinigte Staaten, 11365
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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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Cary, North Carolina, Vereinigte Staaten, 27518
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Durham, North Carolina, Vereinigte Staaten, 27713
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Morehead City, North Carolina, Vereinigte Staaten, 28557
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45242
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Cleveland, Ohio, Vereinigte Staaten, 44122
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Columbus, Ohio, Vereinigte Staaten, 43210
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Dayton, Ohio, Vereinigte Staaten, 45439
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Delaware, Ohio, Vereinigte Staaten, 43015
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Perrysburg, Ohio, Vereinigte Staaten, 43551
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Oregon
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Bend, Oregon, Vereinigte Staaten, 97701
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Corvallis, Oregon, Vereinigte Staaten, 97330
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Eugene, Oregon, Vereinigte Staaten, 97401
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Pennsylvania
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Beaver, Pennsylvania, Vereinigte Staaten, 15009
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Danville, Pennsylvania, Vereinigte Staaten, 17822
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Levittown, Pennsylvania, Vereinigte Staaten, 19056
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
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Wilkes Barre, Pennsylvania, Vereinigte Staaten, 18711
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29412
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Greenville, South Carolina, Vereinigte Staaten, 29605
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Greer, South Carolina, Vereinigte Staaten, 29651
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Myrtle Beach, South Carolina, Vereinigte Staaten, 29572
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 38119
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Texas
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Arlington, Texas, Vereinigte Staaten, 76014
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Austin, Texas, Vereinigte Staaten, 78731
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Corpus Christi, Texas, Vereinigte Staaten, 78404
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Dallas, Texas, Vereinigte Staaten, 75231
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El Paso, Texas, Vereinigte Staaten, 79925
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San Antonio, Texas, Vereinigte Staaten, 78258
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Schertz, Texas, Vereinigte Staaten, 78154
- 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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Utah
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Ogden, Utah, Vereinigte Staaten, 84403
- 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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St. George, Utah, Vereinigte Staaten, 84790
- 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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West Jordan, Utah, Vereinigte Staaten, 84088
- 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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Washington
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Spokane, Washington, Vereinigte Staaten, 99202
- 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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Tacoma, Washington, Vereinigte Staaten, 98405
- 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:
Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
- HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
- Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
- Willing to inject subcutaneous (SC) medication up to 2 times per day
- Stable weight for 3 months prior to screening
- Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2)
- Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Exclusion Criteria:
- Type 1 Diabetes
- HbA1c equal to or less than 6.5 before randomization or at randomization
- Chronic insulin use
- Taking drugs to promote weight loss by prescription or over the counter
- Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
- History of fluid retention or edema
- History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
- Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
- Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
- Acute or chronic pancreatitis of any form
- Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)
- History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
- A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
- Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
- Organ transplant except cornea
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study
- Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
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: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks |
Andere Namen:
|
|
Experimental: 0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks |
Andere Namen:
|
|
Aktiver Komparator: Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks |
|
|
Placebo-Komparator: Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52). Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks |
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Zeitfenster: Baseline, 26 weeks
|
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
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Baseline, 26 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anzahl der Teilnehmer mit behandlungsbedingten unerwünschten Ereignissen nach 26 Wochen
Zeitfenster: Ausgangswert bis 26 Wochen
|
Ein behandlungsbedingtes unerwünschtes Ereignis (TEAE) wurde als ein Ereignis definiert, das unabhängig von der Ursache oder dem Schweregrad erstmals nach Studienbeginn auftritt oder sich verschlimmert (Schweregradzunahme).
Die Anzahl der Teilnehmer mit einem oder mehreren TEAE wird kumulativ auf 26 Wochen zusammengefasst.
Eine Zusammenfassung schwerwiegender und anderer nicht schwerwiegender unerwünschter Ereignisse, unabhängig von der Ursache, finden Sie im Modul „Gemeldete unerwünschte Ereignisse“.
|
Ausgangswert bis 26 Wochen
|
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Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Zeitfenster: Baseline, 52 weeks
|
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
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Baseline, 52 weeks
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Change From Baseline to 26 Weeks for Body Weight
Zeitfenster: Baseline, 26 weeks
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Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
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Baseline, 26 weeks
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Change From Baseline to 52 Weeks for Body Weight
Zeitfenster: Baseline, 52 weeks
|
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
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Change From Baseline to 26 Weeks on Body Mass Index (BMI)
Zeitfenster: Baseline, 26 weeks
|
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
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Change From Baseline to 52 Weeks on Body Mass Index (BMI)
Zeitfenster: Baseline, 52 weeks
|
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
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Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Zeitfenster: Baseline, 26 weeks
|
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime.
Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
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Baseline, 26 weeks
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Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Zeitfenster: Baseline, 52 weeks
|
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime.
Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
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Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks
Zeitfenster: Baseline, 26 weeks
|
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
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Baseline, 26 weeks
|
|
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks
Zeitfenster: Baseline, 52 weeks
|
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
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Baseline, 52 weeks
|
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Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Zeitfenster: Baseline, 26 weeks
|
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function.
HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults).
HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults).
The normal reference populations were set at 100%.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
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Baseline, 26 weeks
|
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Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Zeitfenster: Baseline, 52 weeks
|
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function.
HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults).
HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults).
The normal reference populations were set at 100%.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks in the EuroQol 5
Zeitfenster: Baseline, 26 weeks
|
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument.
It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem).
These dimensions are converted into a weighted health-state Index Score.
The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead.
The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health).
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
|
Baseline, 26 weeks
|
|
Change From Baseline to 52 Weeks in the EuroQol 5
Zeitfenster: Baseline, 52 weeks
|
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument.
It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem).
These dimensions are converted into a weighted health-state Index Score.
The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead.
The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health).
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version
Zeitfenster: Baseline, 26 weeks
|
The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit.
The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction.
Each item is rated on a 7-point Likert scale.
Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied).
The DTSQ change version (DTSQc) was not collected at 26 weeks.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
|
Baseline, 26 weeks
|
|
Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions
Zeitfenster: Baseline, 52 weeks
|
The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively.
Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction.
Each item is rated on a 7-point Likert scale.
The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living
Zeitfenster: Baseline, 26 weeks
|
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs.
Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do".
The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35.
A higher score indicates better ability to perform activities of daily living.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
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Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living
Zeitfenster: Baseline, 52 weeks
|
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs.
Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do".
The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35.
A higher score indicates better ability to perform activities of daily living.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception
Zeitfenster: Baseline, 26 weeks
|
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public.
Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always.
A single total score is calculated by summing the scores for all 3 items.
Total score ranges between 3 and 15, where a higher score is indicative of better self-perception.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
|
Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception
Zeitfenster: Baseline, 52 weeks
|
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public.
Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always.
A single total score is calculated by summing the scores for all 3 items.
Total score ranges between 3 and 15, where a higher score is indicative of better self-perception.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
Information on cardiovascular (CV) risk factors was collected at baseline.
Data on any new CV event was prospectively collected using a CV event electronic case report form.
At prespecified visits, participants were asked about any new CV event since the previous inquiry.
Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise.
Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack.
The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks.
Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
|
Baseline through 52 weeks
|
|
Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Zeitfenster: Baseline, 26 weeks
|
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33.
Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves.
PR is the interval between the P wave and the QRS complex.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
|
Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Zeitfenster: Baseline, 52 weeks
|
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33.
Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves.
PR is the interval between the P wave and the QRS complex.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Change in Baseline to 26 Weeks on Pulse Rate
Zeitfenster: Baseline, 26 weeks
|
Seated pulse rate was measured.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
|
Change in Baseline to 52 Weeks on Pulse Rate
Zeitfenster: Baseline, 52 weeks
|
Seated pulse rate was measured.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks on Blood Pressure
Zeitfenster: Baseline, 26 weeks
|
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 26 weeks
|
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Change From Baseline to 52 Weeks on Blood Pressure
Zeitfenster: Baseline, 52 weeks
|
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
|
Baseline, 52 weeks
|
|
Number of Participants With Adjudicated Pancreatitis at 26 Weeks
Zeitfenster: Baseline through 26 weeks
|
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 26 weeks
|
|
Number of Participants With Adjudicated Pancreatitis at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5
mg LY2189265 and Placebo/0.75
mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 52 weeks
|
|
Change From Baseline to 26 Weeks on Pancreatic Enzymes
Zeitfenster: Baseline, 26 weeks
|
Amylase (total and pancreas-derived) and lipase concentrations were measured.
|
Baseline, 26 weeks
|
|
Change From Baseline to 52 Weeks on Pancreatic Enzymes
Zeitfenster: Baseline, 52 weeks
|
Amylase (total and pancreas-derived) and lipase concentrations were measured.
|
Baseline, 52 weeks
|
|
Change From Baseline to 26 Weeks on Serum Calcitonin
Zeitfenster: Baseline, 26 weeks
|
Baseline, 26 weeks
|
|
|
Change From Baseline to 52 Weeks on Serum Calcitonin
Zeitfenster: Baseline, 52 weeks
|
Baseline, 52 weeks
|
|
|
Number of Self-reported Hypoglycemic Events at 26 Weeks
Zeitfenster: Baseline through 26 weeks
|
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination).
The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 26 weeks
|
|
Number of Self-reported Hypoglycemic Events at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination).
The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 52 weeks
|
|
Rate of Self-reported Hypoglycemic Events at 26 Weeks
Zeitfenster: Baseline through 26 weeks
|
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination).
The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 26 weeks
|
|
Rate of Self-reported Hypoglycemic Events at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination).
The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 52 weeks
|
|
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks
Zeitfenster: Baseline through 26 weeks
|
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.
Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
|
Baseline through 26 weeks
|
|
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.
Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
|
Baseline through 52 weeks
|
|
Number of Participants With LY2189265 Antibodies at 26 Weeks
Zeitfenster: Baseline through 26 weeks
|
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed.
The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.
|
Baseline through 26 weeks
|
|
Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug
Zeitfenster: 26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose
|
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed.
The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.
|
26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose
|
|
Number of Participants With Treatment Emergent Adverse Events at 52 Weeks
Zeitfenster: Baseline through 52 weeks
|
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity.
The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5
mg LY2189265 and Placebo/0.75
mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 52 weeks
|
|
Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values
Zeitfenster: Baseline, 26 weeks
|
Baseline, 26 weeks
|
|
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Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values
Zeitfenster: Baseline, 52 weeks
|
Baseline, 52 weeks
|
|
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Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Zeitfenster: Baseline, 26 weeks
|
Baseline, 26 weeks
|
|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265
Zeitfenster: 4 weeks, 13 weeks, 26 weeks, and 52 weeks
|
Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
|
4 weeks, 13 weeks, 26 weeks, and 52 weeks
|
Mitarbeiter und Ermittler
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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.
Allgemeine Veröffentlichungen
- Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
- Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
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. Februar 2010
Primärer Abschluss (Tatsächlich)
1. November 2011
Studienabschluss (Tatsächlich)
1. Mai 2012
Studienanmeldedaten
Zuerst eingereicht
5. Februar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Februar 2010
Zuerst gepostet (Schätzen)
8. Februar 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
26. Januar 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Januar 2015
Zuletzt verifiziert
1. Januar 2015
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
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Mittel gegen Fettleibigkeit
- Inkretine
- Dulaglutid
- Metformin
- Pioglitazon
- Exenatide
Andere Studien-ID-Nummern
- 11373
- H9X-MC-GBDA (Andere Kennung: Eli Lilly and Company)
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 .