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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01191268




Registration number
NCT01191268
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010
Date last updated
8/10/2014

Titles & IDs
Public title
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Scientific title
The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)
Secondary ID [1] 0 0
H9X-MC-GBDD
Secondary ID [2] 0 0
11376
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1.5 mg LY2189265 - LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Experimental: 0.75 mg LY2189265 - LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Active comparator: Insulin Glargine - Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline, 26 weeks
Secondary outcome [1] 0 0
Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [2] 0 0
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52
Timepoint [2] 0 0
26 weeks and 52 weeks
Secondary outcome [3] 0 0
Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia
Timepoint [3] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [4] 0 0
Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Timepoint [4] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [5] 0 0
Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose
Timepoint [5] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [6] 0 0
Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)
Timepoint [6] 0 0
Baseline and 26 weeks and 52 weeks
Secondary outcome [7] 0 0
Change From Baseline to 26 and 52 Weeks in Body Weight
Timepoint [7] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [8] 0 0
Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [8] 0 0
Baseline and 52 weeks and 4 weeks after last dose
Secondary outcome [9] 0 0
Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)
Timepoint [9] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [10] 0 0
Change From Baseline to 26 and 52 Weeks in the EQ-5D
Timepoint [10] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [11] 0 0
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
Timepoint [11] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [12] 0 0
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)
Timepoint [12] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [13] 0 0
Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)
Timepoint [13] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [14] 0 0
Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
Timepoint [14] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [15] 0 0
Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [15] 0 0
Baseline and 52 weeks and 4 weeks after last dose
Secondary outcome [16] 0 0
Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
Timepoint [16] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [17] 0 0
Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [17] 0 0
Baseline and 52 weeks and 4 weeks after last dose
Secondary outcome [18] 0 0
Change From Baseline to 26 and 52 Weeks in Blood Pressure
Timepoint [18] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [19] 0 0
Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [19] 0 0
Baseline and 52 weeks and 4 weeks after last dose
Secondary outcome [20] 0 0
Change From Baseline to 26 and 52 Weeks in Pulse Rate
Timepoint [20] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [21] 0 0
Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [21] 0 0
Baseline and 52 weeks and 4 weeks after last dose
Secondary outcome [22] 0 0
Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Timepoint [22] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [23] 0 0
Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
Timepoint [23] 0 0
Baseline, 26 weeks, and 52 weeks
Secondary outcome [24] 0 0
Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [24] 0 0
Baseline through 52 weeks
Secondary outcome [25] 0 0
Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [25] 0 0
Baseline through 26 weeks and 52 weeks
Secondary outcome [26] 0 0
Rate of Self-reported Hypoglycemic Events up to 52 Weeks
Timepoint [26] 0 0
Baseline through 52 weeks
Secondary outcome [27] 0 0
Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks
Timepoint [27] 0 0
Baseline through 52 weeks
Secondary outcome [28] 0 0
Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [28] 0 0
Baseline through 4 weeks after last dose
Secondary outcome [29] 0 0
Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Timepoint [29] 0 0
Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose

Eligibility
Key inclusion criteria
* Type 2 diabetes
* Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
* Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
* Willing to inject subcutaneous medication
* Willing to monitor blood glucose levels and adjust insulin dose
* Willing to maintain a study diary
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
* Stable weight for 3 months prior to screening
* Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Type 1 Diabetes
* Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
* 1 or more episodes of ketoacidosis within 6 months prior to screening
* Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
* Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
* Acute or chronic hepatitis or pancreatitis
* Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
* Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
* Organ transplant except cornea
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
* Known drug or alcohol abuse
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
884
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
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. - Keswick
Recruitment hospital [2] 0 0
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. - Box Hill
Recruitment hospital [3] 0 0
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. - Melbourne
Recruitment postcode(s) [1] 0 0
5035 - Keswick
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
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South Carolina
Country [19] 0 0
United States of America
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Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Cipolletti
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Salta
Country [26] 0 0
Belgium
State/province [26] 0 0
Bonheiden
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Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Genk
Country [29] 0 0
Belgium
State/province [29] 0 0
Liège
Country [30] 0 0
Brazil
State/province [30] 0 0
Belem
Country [31] 0 0
Brazil
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Fortaleza
Country [32] 0 0
Brazil
State/province [32] 0 0
Porto Alegre
Country [33] 0 0
Brazil
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São Paulo
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus
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Denmark
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Hillerod
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Denmark
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Kobenhavn
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Denmark
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Koege
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Denmark
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Kolding
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Greece
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Ampelokipoi
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Greece
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Athens
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Greece
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Nikaias - Piraeus
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Greece
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Thessaloniki
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Hungary
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Bekescsaba
Country [48] 0 0
Hungary
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Budapest
Country [49] 0 0
Hungary
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Gyongyos
Country [50] 0 0
Hungary
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Miskolc
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Hungary
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Nagykanizsa
Country [52] 0 0
Hungary
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Nyiregyhaza
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Hungary
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Papa
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Mexico
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Culiacan
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Monterrey
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Poland
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Gdynia
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Poland
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Lodz
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Poland
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Radzymin
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Poland
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Wroclaw
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Puerto Rico
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Manati
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Puerto Rico
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Yabucoa
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Spain
State/province [69] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Palma De Mallorca
Country [72] 0 0
Spain
State/province [72] 0 0
Pozuelo De Alarcon
Country [73] 0 0
Spain
State/province [73] 0 0
Teruel
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Sweden
State/province [75] 0 0
Karlstad
Country [76] 0 0
Sweden
State/province [76] 0 0
Lund
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Sweden
State/province [77] 0 0
Stockholm
Country [78] 0 0
Taiwan
State/province [78] 0 0
Kaohsiung
Country [79] 0 0
Taiwan
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Sindian City
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Taiwan
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Taichung
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
Yong Kang City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01191268