A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus
NCT ID: NCT01648582
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
774 participants
INTERVENTIONAL
2012-07-31
2014-12-31
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
NONE
Study Groups
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1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
Dulaglutide
Administered SC
Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
0.75 mg Dulaglutide
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
Dulaglutide
Administered SC
Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Insulin Glargine
Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.
Insulin glargine
Administered SC per dosing titration schedule
Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Interventions
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Dulaglutide
Administered SC
Insulin glargine
Administered SC per dosing titration schedule
Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
* Adult men or adult non-pregnant, non-breastfeeding women
* Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m\^2)
* Stable weight (±5%) ≥3 months prior to screening
Exclusion Criteria
* Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
* Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
* 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 millimeter 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 picograms per 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
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Dalian, , 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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Nanchang, , China
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Nanjing, , China
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Nanning, , 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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Xi'an, , China
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Yangzhou, , China
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Zhenjiang, , China
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Chihuahua City, , Mexico
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Monterrey, , Mexico
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Bucheon-si, , South Korea
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Kyunggi-Do, , South Korea
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Seoul, , South Korea
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Wŏnju, , South Korea
Countries
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References
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Cai TT, Li HQ, Jiang LL, Wang HY, Luo MH, Su XF, Ma JH. Effects of GLP-1 Receptor Agonists on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus: A 52-Week Clinical Study. Biomed Res Int. 2021 Sep 17;2021:3361309. doi: 10.1155/2021/3361309. eCollection 2021.
Zhou Y, Zhu J, Wu H, Deng Y, Ji Q. Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors. Diabetes Ther. 2021 Oct;12(10):2677-2690. doi: 10.1007/s13300-021-01139-2. Epub 2021 Aug 28.
Ma J, Zhang B, Hou J, Peng Y. Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors. Diabetes Ther. 2021 Jan;12(1):211-222. doi: 10.1007/s13300-020-00955-2. Epub 2020 Nov 8.
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.
Wang J, Li HQ, Xu XH, Kong XC, Sun R, Jing T, Ye L, Su XF, Ma JH. The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus. Biomed Res Int. 2019 Dec 24;2019:2682657. doi: 10.1155/2019/2682657. eCollection 2019.
Li Y, Li L, De Peng Y, Song GY, Ye SD, Du LY, Hou JN, Ji QH. Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2). Diabetes Ther. 2019 Aug;10(4):1435-1452. doi: 10.1007/s13300-019-0646-y. Epub 2019 Jun 21.
Other Identifiers
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H9X-CR-GBDK
Identifier Type: OTHER
Identifier Source: secondary_id
13439
Identifier Type: -
Identifier Source: org_study_id
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