NCT01644500

Brief Summary

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 mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2012

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
3 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

July 17, 2012

Results QC Date

August 3, 2015

Last Update Submit

September 5, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in HbA1c at 26 Weeks

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.

    Baseline, 26 Weeks

Secondary Outcomes (20)

  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks

    26 Weeks

  • Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks

    Baseline, 26 Weeks

  • Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks

    Baseline, 26 Weeks

  • Rate of Hypoglycemic Episodes

    Baseline through 26 Weeks

  • Number of Participants With Self-Reported Hypoglycemic Episodes

    Baseline through 26 Weeks

  • +15 more secondary outcomes

Study Arms (3)

1.5 mg Dulaglutide

EXPERIMENTAL

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.

Drug: DulaglutideDrug: Placebo as Capsules

0.75 mg Dulaglutide

EXPERIMENTAL

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.

Drug: DulaglutideDrug: Placebo as Capsules

Glimepiride

ACTIVE COMPARATOR

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.

Drug: GlimepirideDrug: Placebo as SC Injection

Interventions

DulaglutideDRUG

Administered SC

Also known as: LY2189265
0.75 mg Dulaglutide1.5 mg Dulaglutide
GlimepirideDRUG

Administered orally

Glimepiride
Placebo as CapsulesDRUG

Placebo for glimepiride is administered orally as one to three capsules daily.

0.75 mg Dulaglutide1.5 mg Dulaglutide
Placebo as SC InjectionDRUG

Placebo for dulaglutide is administered as one SC injection.

Glimepiride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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)

You may not qualify if:

  • 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

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, 100088, China

Location

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, 410011, China

Location

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Chengdu, 610041, China

Location

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Chongqing, China

Location

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Guangzhou, 510120, China

Location

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Guiyang, 550004, China

Location

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Hangzhou, 310009, China

Location

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Harbin, 150001, China

Location

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Hefei, 230022, China

Location

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Huai'an, 223300, China

Location

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Jinan, 250001, China

Location

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Nanjing, 210029, China

Location

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Nanning, 530007, China

Location

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Qingdao, 266003, China

Location

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Shanghai, 200040, China

Location

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Shenyang, 110004, China

Location

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Shijiazhuang, 050000, China

Location

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Wuhan, 430022, China

Location

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Wuxi, 214023, China

Location

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Xi'an, 710032, China

Location

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Xiamen, 361003, China

Location

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Gangwon-Do, 200-722, South Korea

Location

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.

Jeju Special Self-Governing Pr, 690-767, South Korea

Location

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, 134-090, South Korea

Location

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.

Changhua, 500, Taiwan

Location

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.

Kaohsiung City, 824, Taiwan

Location

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.

Niao Sung Hsiang, 833, Taiwan

Location

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, 23148, Taiwan

Location

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, 71004, Taiwan

Location

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.

Zhonghe, 235, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 32857293DERIVED

  • 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.

    PMID: 32621083DERIVED

  • 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.

    PMID: 32277401DERIVED

  • 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.

    PMID: 32219675DERIVED

  • 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.

    PMID: 31183384DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideglimepirideCapsules

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 18, 2019

Results First Posted

December 17, 2015

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

CN(21)TW(6)KR(3)