A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01644500
First received: July 17, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dulaglutide
Drug: Glimepiride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β) - cell function (HOMA2-%B) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 789
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Placebo
Placebo for Dulaglutide is administered as one SC injection. Placebo for Glimepiride is administered as one to three capsules daily.
Experimental: 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.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Placebo
Placebo for Dulaglutide is administered as one SC injection. Placebo for Glimepiride is administered as one to three capsules daily.
Active Comparator: Glimepiride
1 to 3 mg/day Glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes.
Drug: Glimepiride
Administered orally
Drug: Placebo
Placebo for Dulaglutide is administered as one SC injection. Placebo for Glimepiride is administered as one to three capsules daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • 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 participant or ≥6.5% to ≤10.0% for participant 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/square meter (kg/m^2)

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • 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 millimeter of mercury [mmHg] or diastolic blood pressure above 95 mmHg)
  • Impaired liver function
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644500

Locations
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.
Beijing, China, 100088
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, 410011
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Chengdu, China, 610041
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Chongqing, China
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Guang Zhou, China, 510120
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Guiyang, China, 550004
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Hangzhou, China, 310009
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Harbin, China, 150001
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Hefei, China, 230022
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Huai'An, China, 223300
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Jinan, China, 250001
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Nanjing, China, 210029
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Nanning, China, 530007
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Qingdao, China, 266003
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Shanghai, China, 200040
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Shenyang, China, 110004
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Shijiazhuang, China, 050000
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Wu Han, China, 430022
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Wuxi, China, 214023
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Xi'An, China, 710032
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Xiamen, China, 361003
Korea, Republic of
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.
Gangwon-Do, Korea, Republic of, 200-722
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Jeju Special Self-Governing Pr, Korea, Republic of, 690-767
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Seoul, Korea, Republic of, 134-090
Taiwan
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Changhua, Taiwan, 500
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Jhonghe City, Taiwan, 235
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Kaohsiung, Taiwan, 824
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Niao Sung Hsiang, Taiwan, 833
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Sindian City, Taiwan, 23148
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.
Yong Kung City, Taiwan, 71004
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01644500     History of Changes
Other Study ID Numbers: 11991, H9X-JE-GBCG
Study First Received: July 17, 2012
Last Updated: August 22, 2014
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
India: Ministry of Health
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 14, 2014