Type 2 DiabetesPhase 3AWARD-6NCT01624259
A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
A Phase 3 study testing LY2189265, Liraglutide and Metformin in people with Type 2 Diabetes, run by Eli Lilly and Company at 57 sites in 10 countries.
Trial summary
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- LY2189265, Liraglutide and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 57 sitesin 10 countries
- Study dates
- Jun 2012to Nov 2013
- 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
- Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
- Accept continued treatment with metformin throughout the trial, as required per protocol
- Men and nonpregnant women aged greater than or equal to 18 years
- Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
- Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)
Who cannot join
- Have type 1 diabetes mellitus
- Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 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 use within 3 months prior to the first study visit
- Have been treated with drugs that promote weight loss within 3 months of the first study visit
- Are receiving chronic (greater than 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 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 (such as, 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 greater than or equal to 3 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 a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) 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, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
United States18 sites
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Chino, California, 91710
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Dallas, Texas, 75230
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Fort Lauderdale, Florida, 33316
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Fresno, California, 93720
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Hurst, Texas, 76054
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Kingsport, Tennessee, 37660
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Las Vegas, Nevada, 89119
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Los Angeles, California, 90057
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Louisville, Kentucky, 40218
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Miami, Florida, 33175
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Oviedo, Florida, 32765
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Perrysburg, Ohio, 43551
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Phoenix, Arizona, 85027
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Royal Oak, Michigan, 48073
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San Antonio, Texas, 78228
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Shreveport, Louisiana, 71101
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Spring Valley, California, 91978
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Topeka, Kansas, 66606
Poland9 sites
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Bialystok, 15-445
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Gdansk, 80-546
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Kamieniec Ząbkowicki, 57-230
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Lodz, 90-242
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Poznan, 61-853
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Ruda Śląska, 41-709
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Szczecin, 70-506
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Tychy, 43-100
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Wroclaw, 50-306
Germany7 sites
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Dresden, 01307
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Hohenmölsen, 06679
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Lingen, 49808
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Mainz, 55116
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Neunkirchen, 66539
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Saint Ingbert-Oberwürzbach, 66386
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Sulzbach, 92237
Spain7 sites
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Alicante, 03114
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Alzira, 46600
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Barcelona, 08022
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Centelles, 08540
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Málaga, 29006
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Palma de Mallorca, 07014
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Petrel, 03610
Hungary4 sites
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Budapest, H-1139
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Debrecen, 4043
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Dombóvár, 7200
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Székesfehérvár, 8000
Romania4 sites
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Bucharest, 020045
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Galati, 800098
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Ploieşti, 100342
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Sibiu, 550371
Slovakia4 sites
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Košice, 04012
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Malacky, 90101
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Nitra, 94901
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Nové Mesto nad Váhom, 91501
Puerto Rico2 sites
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Hato Rey, 00917
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Rio Grande, 00745
Czechia1 site
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Prague, 181 00
Mexico1 site
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Monterrey, 64620
About this study
Official title: A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
- Conditions
- Type 2 Diabetes
- Being tested
- LY2189265, Liraglutide, Metformin
- 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.
LY2189265Drug
Also called Dulaglutide
Administered SC
LiraglutideDrug
Administered SC
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks Receives: Drug: LY2189265; Drug: Metformin |
| Liraglutide | Active comparator | Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks Receives: Drug: Liraglutide; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
Measured: Baseline, 26 Weeks
Secondary outcomes (22)
Change From Baseline in Body Weight at 26 Weeks
LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.
Measured: Baseline, Up to 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 of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.
Measured: Baseline, Up to 26 Weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks
LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.
Measured: Baseline, Up to 26 Weeks
Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks
The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.
LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML.
Measured: Baseline, 26 Weeks
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks
The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.
Measured: Up to 26 Weeks
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.
LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF.
Measured: Baseline, Up to 26 Weeks
Number of Participants With Reported and Adjudicated Cardiovascular Events
Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include 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. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline up to 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks
ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.
Measured: Baseline, Up to 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals 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. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.
Measured: Baseline, 26 Weeks
Change From Baseline in Heart Rate (HR) at 26 Weeks
Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.
Measured: Baseline, 26 Weeks
Change From Baseline in Blood Pressure (BP) at 26 Weeks
Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.
Measured: Baseline, 26 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline up to 30 Weeks
Change From Baseline in Calcitonin at 26 Weeks
A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.
Measured: Baseline, Up to 26 Weeks
Change From Baseline in Lipase at 26 Weeks
A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.
Measured: Baseline, Up to 26 Weeks
Change From Baseline in Amylase at 26 Weeks
A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.
Measured: Baseline, Up to 26 Weeks
Percentage of Participants With Self-Reported Hypoglycemia Events
Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
Percentage of Participants Requiring 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.
Measured: Baseline through 26 Weeks
Rate of Hypoglycemic Events Adjusted Per 30 Days
HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 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 26 Weeks
Number of Participants With Allergic or Hypersensitivity Reactions
Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose
LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 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. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.
Measured: Baseline up to 4 Weeks Post Last Dose of Study Drug
Percent Change From Baseline in Lipid Parameters at 26 Weeks
A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.
Measured: Baseline, Up to 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionNov 2013
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 (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 599 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
- NCT01624259
- Sponsor's protocol ID
- 11377
- Other IDs
- H9X-MC-GBDE, 2011-003810-18
- Acronym
- AWARD-6
- Status last verified
- Oct 2014
- First submitted
- 18 Jun 2012
- Last updated
- 9 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
PubMed 27161178Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
PubMed 26691396Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. doi: 10.1016/S0140-6736(14)60976-4. Epub 2014 Jul 10.
PubMed 25018121
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
- ClinicalTrials.gov ID
- NCT01624259
- Acronym / sponsor ID
- AWARD-6 / 11377
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Posted 9 Oct 2014
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 the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg LY2189265 | Experimental | Drug: LY2189265, Drug: MetforminLY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks |
| Liraglutide | Active comparator | Drug: Liraglutide, Drug: MetforminLiraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks |
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
- Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
- Accept continued treatment with metformin throughout the trial, as required per protocol
- Men and nonpregnant women aged greater than or equal to 18 years
Key exclusion criteria (13 listed)
- Have type 1 diabetes mellitus
- Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 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 use within 3 months prior to the first study visit
- Have been treated with drugs that promote weight loss within 3 months of the first study visit
- Are receiving chronic (greater than 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 |
|---|---|---|
| LY2189265Also: DulaglutideAdministered SC | Drug | 1.5 mg LY2189265 |
| LiraglutideAdministered SC | Drug | Liraglutide |
| Metformin | Drug | 1.5 mg LY2189265, Liraglutide |
Primary outcome
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 26 Weeks
Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
22 secondary outcomes
Change From Baseline in Body Weight at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in Body Mass Index (BMI) at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks
Time frame: Baseline, 26 Weeks
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks
Time frame: Up to 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
Number of Participants With Reported and Adjudicated Cardiovascular Events
Time frame: Baseline up to 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Heart Rate (HR) at 26 Weeks
Time frame: Baseline, 26 Weeks
Change From Baseline in Blood Pressure (BP) at 26 Weeks
Time frame: Baseline, 26 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
Time frame: Baseline up to 30 Weeks
Change From Baseline in Calcitonin at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in Lipase at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Change From Baseline in Amylase at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Percentage of Participants With Self-Reported Hypoglycemia Events
Time frame: Baseline through 26 Weeks
Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
Time frame: Baseline through 26 Weeks
Rate of Hypoglycemic Events Adjusted Per 30 Days
Time frame: Baseline through 26 Weeks
Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
Time frame: Baseline through 26 Weeks
Number of Participants With Allergic or Hypersensitivity Reactions
Time frame: Baseline through 26 Weeks
Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose
Time frame: Baseline up to 4 Weeks Post Last Dose of Study Drug
Percent Change From Baseline in Lipid Parameters at 26 Weeks
Time frame: Baseline, Up to 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27161178Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
- Derived from this study: PubMed 26691396Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
- Derived from this study: PubMed 25018121Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. doi: 10.1016/S0140-6736(14)60976-4. Epub 2014 Jul 10.
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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
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2189265, Liraglutide and Metformin in people with Type 2 Diabetes, run by Eli Lilly and Company at 57 sites in 10 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 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Poland, Germany, Spain, Hungary and 5 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. 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 9 Oct 2014). 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 to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (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 NCT01624259, which also lists 3 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 9 Oct 2014.