A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine 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:
NCT01648582
First received: July 16, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with one or two oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea) in addition to any healthy lifestyle changes recommended by their healthcare providers.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dulaglutide
Drug: Insulin glargine
Drug: Metformin
Drug: Sulfonylureas
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

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:
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 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 and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 789
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 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 added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea. Participants are blinded to the Dulaglutide dose.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Experimental: 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. Participants are blinded to the Dulaglutide dose.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Active Comparator: Insulin Glargine
Insulin Glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
Drug: Insulin glargine
Administered SC per dosing titration schedule
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

  Eligibility

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

Inclusion Criteria:

  • Have type 2 diabetes mellitus for at least 6 months
  • 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
  • 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 type 1 diabetes mellitus
  • Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
  • Have treatment with dipeptidylpeptidase-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)
  • 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: NCT01648582

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, 100730
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
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.
Chongqing, China, 400030
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.
Dalian, China, 116011
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.
Guang Zhou, China, 510120
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.
Guiyang, China, 550004
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.
Hangzhou, China, 310009
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.
Harbin, China, 150001
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.
Hefei, China, 230022
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.
Nanchang, China, 330006
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.
Nanjing, China, 210006
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.
Nanning, China, 530021
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.
Shanghai, China, 200080
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.
Shenyang, China, 110004
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.
Shijiazhuang, China, 050051
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.
Wu Han, China, 430022
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.
Xi'An, China, 710032
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.
Yangzhou, China, 225001
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.
Zhenjiang, China, 212000
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.
Bucheon,, Korea, Republic of, 420-717
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.
Kyunggi-Do, Korea, Republic of, 425-020
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.
Seoul, Korea, Republic of, 137-701
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.
Wonju-Si, Korea, Republic of, 220-701
Mexico
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.
Chihuahua, Mexico, 31238
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.
Monterrey, Mexico, 64460
Russian Federation
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.
Chelyabinsk, Russian Federation, 454047
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.
Moscow, Russian Federation, 127018
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.
Saint Petersburg, Russian Federation, 192012
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.
Sankt-Petersburg, Russian Federation, 190000
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: NCT01648582     History of Changes
Other Study ID Numbers: 13439, H9X-CR-GBDK
Study First Received: July 16, 2012
Last Updated: February 18, 2014
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
India: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014