A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
NCT ID: NCT01644500
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
737 participants
INTERVENTIONAL
2012-07-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
Dulaglutide
Administered SC
Placebo as Capsules
Placebo for glimepiride is administered orally as one to three capsules daily.
0.75 mg Dulaglutide
0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
Dulaglutide
Administered SC
Placebo as Capsules
Placebo for glimepiride is administered orally as one to three capsules daily.
Glimepiride
1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
Glimepiride
Administered orally
Placebo as SC Injection
Placebo for dulaglutide is administered as one SC injection.
Interventions
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Dulaglutide
Administered SC
Glimepiride
Administered orally
Placebo as Capsules
Placebo for glimepiride is administered orally as one to three capsules daily.
Placebo as SC Injection
Placebo for dulaglutide is administered as one SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* OAM-naïve or have been taking OAM monotherapy for at least 3 months
* Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy
* Adult men or adult non-pregnant, non-breastfeeding women
* Stable weight (±5%) ≥3 months prior to screening
* Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m\^2)
Exclusion Criteria
* Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
* Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
* Have gastric emptying abnormality
* Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
* Have poorly controlled hypertension (systolic blood pressure above 160 millimeters of mercury \[mmHg\] or diastolic blood pressure above 95 mmHg)
* Have impaired liver function
* Have impaired kidney function
* Have history of chronic pancreatitis or acute pancreatitis
* Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
* Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Beijing, , China
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.
Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guiyang, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Huai'an, , China
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Jinan, , China
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Nanjing, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Wuhan, , China
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Wuxi, , China
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Xi'an, , China
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Xiamen, , China
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Gangwon-Do, , South Korea
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Jeju Special Self-Governing Pr, , South Korea
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Seoul, , South Korea
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Niao Sung Hsiang, , Taiwan
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.
Sindian City, , Taiwan
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Yong Kung City, , Taiwan
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Zhonghe, , Taiwan
Countries
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References
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Kuang J, Zhu J, Liu S, Li Q. Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies. Diabetes Ther. 2020 Oct;11(10):2329-2339. doi: 10.1007/s13300-020-00910-1. Epub 2020 Aug 28.
Guo L, Zhang B, Hou J, Zhou Z. Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials. Diabetes Ther. 2020 Aug;11(8):1821-1833. doi: 10.1007/s13300-020-00869-z. Epub 2020 Jul 4.
Yu M, Yuan GY, Zhang B, Wu HY, Lv XF. Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis. Diabetes Ther. 2020 May;11(5):1147-1159. doi: 10.1007/s13300-020-00804-2. Epub 2020 Apr 10.
Li YM, Zhang LH, Li XJ, Zhang B, Hou JN, Tong NW. Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naive Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1. Diabetes Ther. 2020 May;11(5):1077-1090. doi: 10.1007/s13300-020-00799-w. Epub 2020 Mar 26.
Li H, Xu X, Wang J, Kong X, Chen M, Jing T, Zhang Z, Yin G, Liu X, Hu Y, Ye L, Su X, Ma J. A Randomized Study to Compare the Effects of Once-Weekly Dulaglutide Injection and Once-Daily Glimepiride on Glucose Fluctuation of Type 2 Diabetes Mellitus Patients: A 26-Week Follow-Up. J Diabetes Res. 2019 Apr 30;2019:6423987. doi: 10.1155/2019/6423987. eCollection 2019.
Other Identifiers
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H9X-JE-GBCG
Identifier Type: OTHER
Identifier Source: secondary_id
11991
Identifier Type: -
Identifier Source: org_study_id
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