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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01644500
First received: July 17, 2012
Last updated: March 31, 2014
Last verified: March 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
Estimated Study Completion Date: August 2014
Estimated 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
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
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.
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
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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: March 31, 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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014