NCT01769378|CompletedPhase 3Results

Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

AWARD-8

A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

13193H9X-MC-GBDG

Study Type

interventional

Target

300

Locations

8 countries

Sites

Timeline

RegisteredJan 2013

StartedJan 2013

CompletionDec 2014

Brief Summary

The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

300

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline

Completed

Started Jan 2013

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach

8 countries

31 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

1.9 years study duration

Study Start

First participant enrolled

January 1, 2013

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed

11 months until next milestone

Results Posted

Study results publicly available

October 14, 2015

Completed

Last Updated

January 25, 2016

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

January 14, 2013

Results QC Date

September 14, 2015

Last Update Submit

December 18, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks
Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
Baseline, 24 Weeks

Secondary Outcomes (15)

Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks
24 Weeks
Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks
Baseline, 24 Weeks
Change From Baseline in Body Weight at 24 Weeks
Baseline, 24 Weeks
Change From Baseline in Body Mass Index (BMI) at 24 Weeks
Baseline, 24 Weeks
Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks
Baseline, 24 Weeks
+10 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

Drug: PlaceboDrug: Glimepiride

Dulaglutide

EXPERIMENTAL

Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

Drug: DulaglutideDrug: Glimepiride

Interventions

PlaceboDRUG

Administered SQ

Placebo

DulaglutideDRUG

Administered SQ

Also known as: LY2189265

Dulaglutide

GlimepirideDRUG

Administered PO

DulaglutidePlacebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes mellitus
Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit
Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit
Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol
Men and nonpregnant women aged ≥18 years
Stable weight (±5%) ≥3 months prior to screening
Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m\^2)

You may not qualify if:

Have type 1 diabetes mellitus
Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months prior to the first study visit
Have been treated with drugs that promote weight loss within 3 months prior to the first study visit
Are receiving chronic (\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
Have had any of the following Cardiovascular (CV) conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level \>2.5 times the upper limit of normal
Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
Have an estimated glomerular filtration rate \[eGFR\] \<30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation as determined by the central laboratory at the first study visit
Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
Have a serum calcitonin ≥20 picogram per milliliter (pg/mL) as determined by the central laboratory at the first study visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (31)

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.

Chino, California, 91710, United States

Location

Miami, Florida, 33175, United States

Location

St Louis, Missouri, 63141, United States

Location

Trenton, New Jersey, 08611, United States

Location

The Bronx, New York, 10461, United States

Location

Beaver, Pennsylvania, 15009, United States

Location

Buenos Aires, (C1056ABJ), Argentina

Location

Caba, C1204AAD, Argentina

Location

Corrientes, 3400, Argentina

Location

Rosario, 2000, Argentina

Location

Salzburg, 5026, Austria

Location

Zams, 6511, Austria

Location

Krapinske Toplice, 49217, Croatia

Location

Osijek, 31000, Croatia

Location

Rijeka, HR-51000, Croatia

Location

Slavonski Brod, 35000, Croatia

Location

Varaždin, 42000, Croatia

Location

Zagreb, 10000, Croatia

Location

Mexico City, 06700, Mexico

Location

Tampico, 89000, Mexico

Location

Alba Iulia, 510053, Romania

Location

Bucharest, 13682, Romania

Location

Galati, 800098, Romania

Location

Iași, 700547, Romania

Location

Oradea, 410169, Romania

Location

Sibiu, 550371, Romania

Location

Celje, 3000, Slovenia

Location

Ljubljana, 1000, Slovenia

Location

Bloemfontein, 9301, South Africa

Location

Durban, 4092, South Africa

Location

Somerset West, 7130, South Africa

Location

Related Publications (1)

Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
PMID: 36894938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 25, 2016

Results First Posted

October 14, 2015

Record last verified: 2015-12

Locations

CR(6)SL(2)RO(6)ZA(3)AU(2)ME(2)US(6)AR(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Placebo

Dulaglutide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations