The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
591
Administered SC
Administered orally
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.
Time frame: Baseline, Week 26
Change From Baseline in HbA1c at Week 52
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Time frame: Baseline, Week 52
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Time frame: Week 52
Change From Baseline in Fasting Serum Glucose (FSG)
FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables.
Time frame: Baseline, Week 52
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.
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Nakayama Clinic
Nagoya, Aichi-ken, Japan
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, Japan
Kashiwa City Hospital
Kashiwa, Chiba, Japan
Kobari General Clinic
Noda, Chiba, Japan
Nippon Kokan Fukuyama Hospital
Fukuyama-shi, Hiroshima, Japan
Yamagata Naika Clinic
Asahikawa, Hokkaido, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, Japan
Yuri Ono Clinic
Sapporo, Hokkaido, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, Japan
Miyanosawa Clinic of Internal Medicine and Cardiology
Sapporo, Hokkaido, Japan
...and 34 more locations
Time frame: Baseline, Week 26
Change From Baseline in Body Weight
LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables.
Time frame: Baseline, Week 52