Type 2 Diabetes MellitusPhase 3AWARD-8NCT01769378
Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
A Phase 3 study testing Dulaglutide and Glimepiride in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 31 sites in 8 countries.
Trial 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. 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 31 sitesin 8 countries
- Study dates
- Jan 2013to Dec 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
- 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)
Who cannot join
- 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 used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary
- 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
Show all 13Show fewer
- 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 type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
- 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
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States6 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.
Beaver, Pennsylvania, 15009
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Chino, California, 91710
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Miami, Florida, 33175
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St Louis, Missouri, 63141
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The Bronx, New York, 10461
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Trenton, New Jersey, 08611
Croatia6 sites
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Krapinske Toplice, 49217
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Osijek, 31000
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Rijeka, HR-51000
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Slavonski Brod, 35000
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Varaždin, 42000
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Zagreb, 10000
Romania6 sites
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Alba Iulia, 510053
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Bucharest, 13682
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Galati, 800098
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Iași, 700547
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Oradea, 410169
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Sibiu, 550371
Argentina4 sites
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Buenos Aires, (C1056ABJ)
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Caba, C1204AAD
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Corrientes, 3400
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Rosario, 2000
South Africa3 sites
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Bloemfontein, 9301
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Durban, 4092
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Somerset West, 7130
Austria2 sites
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Salzburg, 5026
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Zams, 6511
Mexico2 sites
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Mexico City, 06700
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Tampico, 89000
Slovenia2 sites
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Celje, 3000
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Ljubljana, 1000
About this study
Official title: 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)
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Placebo, Dulaglutide, Glimepiride
- 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.
PlaceboDrug
Administered SQ
DulaglutideDrug
Also called LY2189265
Administered SQ
GlimepirideDrug
Administered PO
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Receives: Drug: Placebo; Drug: Glimepiride |
| Dulaglutide | Experimental | Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Receives: Drug: Dulaglutide; Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 24 Weeks
Secondary outcomes (15)
Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks
The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.
Measured: 24 Weeks
Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks
LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).
Measured: Baseline, 24 Weeks
Change From Baseline in Body Weight at 24 Weeks
LS Means of the body weight 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 body weight as covariate, via a MMRM analysis using REML.
Measured: Baseline, 24 Weeks
Change From Baseline in Body Mass Index (BMI) at 24 Weeks
LS Means of the BMI 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 BMI as covariate, via a MMRM analysis using REML.
Measured: Baseline, 24 Weeks
Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks
LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.
Measured: Baseline, 24 Weeks
Number of Participants With Reported and Adjudicated Cardiovascular Events
Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Measured: Baseline through 24 Weeks, 30-day Follow Up
Number of Participants With Adjudicated Acute Pancreatitis Events
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 24 Weeks, 30-day Follow Up
Change From Baseline in Calcitonin at 24 Weeks
Measured: Baseline, 24 Weeks
Percentage of Participants With Self-Reported Events of Hypoglycemia
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.
Measured: Baseline through 24 Weeks
Rate of HE Adjusted Per 30 Days
The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.
Measured: Baseline through 24 weeks
Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Measured: Baseline through 24 Weeks
Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.
Measured: Baseline through 24 Weeks
Dulaglutide Anti-Drug Antibodies (ADA)
Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Measured: Baseline up to 4 Weeks Post-Last Dose of Study Drug
Change From Baseline in Lipase
A summary of changes in lipase evaluation from baseline to endpoint.
Measured: Baseline, 24 Weeks
Change From Baseline in Amylase
A summary of changes in amylase evaluation from baseline to endpoint.
Measured: Baseline, 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 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 (1)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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769378
- Sponsor's protocol ID
- 13193
- Other IDs
- H9X-MC-GBDG
- Acronym
- AWARD-8
- Status last verified
- Dec 2015
- First submitted
- 14 Jan 2013
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36894938
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01769378
- Acronym / sponsor ID
- AWARD-8 / 13193
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: GlimepiridePlacebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose. |
| Dulaglutide | Experimental | Drug: Dulaglutide, Drug: GlimepirideDulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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 used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary
- 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
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 |
|---|---|---|
| PlaceboAdministered SQ | Drug | Placebo |
| DulaglutideAlso: LY2189265Administered SQ | Drug | Dulaglutide |
| GlimepirideAdministered PO | Drug | Dulaglutide, Placebo |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks
Time frame: Baseline, 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).
15 secondary outcomes
Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks
Time frame: 24 Weeks
Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks
Time frame: Baseline, 24 Weeks
Change From Baseline in Body Weight at 24 Weeks
Time frame: Baseline, 24 Weeks
Change From Baseline in Body Mass Index (BMI) at 24 Weeks
Time frame: Baseline, 24 Weeks
Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks
Time frame: Baseline, 24 Weeks
Number of Participants With Reported and Adjudicated Cardiovascular Events
Time frame: Baseline through 24 Weeks, 30-day Follow Up
Number of Participants With Adjudicated Acute Pancreatitis Events
Time frame: Baseline through 24 Weeks, 30-day Follow Up
Change From Baseline in Calcitonin at 24 Weeks
Time frame: Baseline, 24 Weeks
Percentage of Participants With Self-Reported Events of Hypoglycemia
Time frame: Baseline through 24 Weeks
Rate of HE Adjusted Per 30 Days
Time frame: Baseline through 24 weeks
Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
Time frame: Baseline through 24 Weeks
Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
Time frame: Baseline through 24 Weeks
Dulaglutide Anti-Drug Antibodies (ADA)
Time frame: Baseline up to 4 Weeks Post-Last Dose of Study Drug
Change From Baseline in Lipase
Time frame: Baseline, 24 Weeks
Change From Baseline in Amylase
Time frame: Baseline, 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36894938Ferdinand 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.
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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
31 sites in 8 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 31 sites in 8 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 7 inclusion and 13 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Croatia, Romania, Argentina, South Africa and 3 more countries. 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. Some participants in this study may receive a placebo. 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 14 Oct 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 Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks (time frame: Baseline, 24 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 NCT01769378, which also lists 1 linked publication.
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 25 Jan 2016.