Type 2 Diabetes MellitusPhase 3AWARD-CHN1NCT01644500

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

A Phase 3 study testing Dulaglutide and Glimepiride in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 30 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dulaglutide and Glimepiride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 737 participants
Where: 30 sitesin 3 countries
Study dates: Jul 2012to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

Show all 11Show fewer

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)

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

China21 sites

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
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Changsha, 410011
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Chengdu, 610041
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Chongqing
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Guangzhou, 510120
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Guiyang, 550004
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Hangzhou, 310009
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Harbin, 150001
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Hefei, 230022
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Huai'an, 223300
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Jinan, 250001
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Nanjing, 210029
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Nanning, 530007
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Qingdao, 266003
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Shanghai, 200040
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Shenyang, 110004
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Shijiazhuang, 050000
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Wuhan, 430022
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Wuxi, 214023
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Xi'an, 710032
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Xiamen, 361003

Other trials in China

Taiwan6 sites

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
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Kaohsiung City, 824
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Niao Sung Hsiang, 833
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Sindian City, 23148
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Yong Kung City, 71004
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Zhonghe, 235

Other trials in Taiwan

South Korea3 sites

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, 200-722
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Jeju Special Self-Governing Pr, 690-767
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Seoul, 134-090

Other trials in South Korea

About this study

Official title: The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Dulaglutide, Glimepiride, Placebo as Capsules, Placebo as SC Injection
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DulaglutideDrug
Also called LY2189265
Administered SC
GlimepirideDrug
Administered orally
Placebo as CapsulesDrug
Placebo for glimepiride is administered orally as one to three capsules daily.
Placebo as SC InjectionDrug
Placebo for dulaglutide is administered as one SC injection.

Study groups in NCT01644500
Study group	Role	What they receive
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. Receives: Drug: Dulaglutide; Drug: 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. Receives: Drug: Dulaglutide; Drug: 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. Receives: Drug: Glimepiride; Drug: Placebo as SC Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 26 Weeks

Secondary outcomes (20)

Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks
Percentages of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.
Measured: 26 Weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks
Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Rate of Hypoglycemic Episodes
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants.
Measured: Baseline through 26 Weeks
Number of Participants With Self-Reported Hypoglycemic Episodes
The overall number of participants with self-reported hypoglycemic episodes is presented.
Measured: Baseline through 26 Weeks
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks
Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects.
Measured: Baseline, up to 26 Weeks
Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks
Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects.
Measured: Baseline, up to 26 Weeks
Change From Baseline in Pancreatic Enzymes at 26 Weeks
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Measured: Baseline, 26 Weeks
Change From Baseline in Serum Calcitonin at 26 Weeks
Measured: Baseline, 26 Weeks
Change From Baseline in Sitting Blood Pressure at 26 Weeks
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline blood pressure as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Change From Baseline in Sitting Pulse Rate at 26 Weeks
LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline pulse rate as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
Measured: Baseline, 26 Weeks
Change From Baseline in Heart Rate From ECG at 26 Weeks
Measured: Baseline, 26 Weeks
Change From Baseline in Body Weight at 26 Weeks
LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Change From Baseline in Body Mass Index (BMI) at 26 Weeks
BMI is an estimate of body fat based on body weight divided by height squared. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.
Measured: Baseline, 26 Weeks
Percentage of Participants Developing Antibodies to Dulaglutide
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline and 26 weeks. A participant was considered to have treatment-emergent dulaglutide ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Measured: Baseline through 26 Weeks
Number of Participants With Adjudicated Cardiovascular Events
Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs that were adjudicated included myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
Number of Participants With Adjudicated Pancreatitis
The number of adjudicated (by an independent committee of expert physicians) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks
The EQ-5D questionnaire is a widely used, generic questionnaire that assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 5 response categories is summarized for each of the 5 dimensions.
Measured: Week 26
Visual Analog Scale (VAS) Score at 26 Weeks
The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life and consists of a 100-milliliter (mm) visual analog scale (VAS) on which the participant rated their perceived health state on that day from 0-mm (worst imaginable health state) to 100-mm (best imaginable health state).
Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Aug 2014

First posted19 Jul 2012 (estimated)
Study startJul 2012
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 737 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01644500
Sponsor's protocol ID: 11991
Other IDs: H9X-JE-GBCG
Acronym: AWARD-CHN1
Status last verified: Sep 2019
First submitted: 17 Jul 2012
Last updated: 18 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Publications

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.
PubMed 32857293
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.
PubMed 32621083
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.
PubMed 32277401
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.
PubMed 32219675
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.
PubMed 31183384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01644500
Acronym / sponsor ID: AWARD-CHN1 / 11991
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 737 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 19 Jul 2012 (estimated)
Results: Posted 17 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1.5 mg Dulaglutide	Experimental	Drug: Dulaglutide, Drug: Placebo as Capsules1.5 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.
0.75 mg Dulaglutide	Experimental	Drug: Dulaglutide, Drug: Placebo as Capsules0.75 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.
Glimepiride	Active comparator	Drug: Glimepiride, Drug: Placebo as SC Injection1 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DulaglutideAlso: LY2189265Administered SC	Drug	0.75 mg Dulaglutide, 1.5 mg Dulaglutide
GlimepirideAdministered orally	Drug	Glimepiride
Placebo as CapsulesPlacebo for glimepiride is administered orally as one to three capsules daily.	Drug	0.75 mg Dulaglutide, 1.5 mg Dulaglutide
Placebo as SC InjectionPlacebo for dulaglutide is administered as one SC injection.	Drug	Glimepiride

Primary outcome

Change From Baseline in HbA1c at 26 Weeks
Time frame: Baseline, 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.

20 secondary outcomes

Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks
Time frame: 26 Weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks
Time frame: Baseline, 26 Weeks
Rate of Hypoglycemic Episodes
Time frame: Baseline through 26 Weeks
Number of Participants With Self-Reported Hypoglycemic Episodes
Time frame: Baseline through 26 Weeks
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks
Time frame: Baseline, up to 26 Weeks
Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks
Time frame: Baseline, up to 26 Weeks
Change From Baseline in Pancreatic Enzymes at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Serum Calcitonin at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Sitting Blood Pressure at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Sitting Pulse Rate at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Heart Rate From ECG at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Body Weight at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Body Mass Index (BMI) at 26 Weeks
Time frame: Baseline, 26 Weeks
Percentage of Participants Developing Antibodies to Dulaglutide
Time frame: Baseline through 26 Weeks
Number of Participants With Adjudicated Cardiovascular Events
Time frame: Baseline through 26 Weeks
Number of Participants With Adjudicated Pancreatitis
Time frame: Baseline through 26 Weeks
European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks
Time frame: Week 26
Visual Analog Scale (VAS) Score at 26 Weeks
Time frame: Week 26

Results and safety

Results posted to the registry on 17 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1.5 mg Dulaglutide	244	222
0.75 mg Dulaglutide	248	224
Glimepiride	245	230

Primary outcome: Change From Baseline in HbA1c at 26 Weeks

Time frame: Baseline, 26 Weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	1.5 mg Dulaglutide n = 239	0.75 mg Dulaglutide n = 239	Glimepiride n = 242
Value	-1.48 (0.069)	-1.22 (0.069)	-0.92 (0.069)

1.5 mg Dulaglutide vs Glimepiride: Mean Difference (Net): -0.58 (95% CI -0.76 to -0.39), p <0.001, Mixed Models Analysis
0.75 mg Dulaglutide vs Glimepiride: Mean Difference (Net): -0.32 (95% CI -0.50 to -0.13), p <0.001, Mixed Models Analysis

Population analysed: Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.

20 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1.5 mg Dulaglutide	6 of 244 (2.5%)	165 of 244 (67.6%)	Not reported
0.75 mg Dulaglutide	4 of 248 (1.6%)	141 of 248 (56.9%)	Not reported
Glimepiride	3 of 243 (1.2%)	137 of 243 (56.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32857293Kuang 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.
Derived from this study: PubMed 32621083Guo 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.
Derived from this study: PubMed 32277401Yu 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.
Derived from this study: PubMed 32219675Li 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.
Derived from this study: PubMed 31183384Li 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide and Glimepiride in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China, Taiwan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at 26 Weeks (time frame: Baseline, 26 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644500, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.