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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01075282




Registration number
NCT01075282
Ethics application status
Date submitted
23/02/2010
Date registered
25/02/2010
Date last updated
16/01/2015

Titles & IDs
Public title
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
Scientific title
A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Secondary ID [1] 0 0
H9X-MC-GBDB
Secondary ID [2] 0 0
11374
Universal Trial Number (UTN)
Trial acronym
AWARD-2
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: LY2189265 1.5 mg - LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

Experimental: LY2189265 0.75 mg - LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

Active comparator: Insulin Glargine - Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks

Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [1] 0 0
Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline, 26 weeks, and 78 weeks
Secondary outcome [2] 0 0
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks
Timepoint [2] 0 0
26, 52, and 78 weeks
Secondary outcome [3] 0 0
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks
Timepoint [3] 0 0
26, 52, and 78 weeks
Secondary outcome [4] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles
Timepoint [4] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [5] 0 0
Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Timepoint [5] 0 0
Baseline, 52, and 78 weeks
Secondary outcome [6] 0 0
Change From Baseline to 52 and 78 Weeks in Glucagon Concentration
Timepoint [6] 0 0
Baseline, 52, and 78 weeks
Secondary outcome [7] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Body Weight
Timepoint [7] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [8] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index
Timepoint [8] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [9] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension
Timepoint [9] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [10] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living
Timepoint [10] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [11] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception
Timepoint [11] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [12] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey
Timepoint [12] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks
Timepoint [13] 0 0
26, 52, and 78 weeks
Secondary outcome [14] 0 0
Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
Timepoint [14] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [15] 0 0
Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
Timepoint [15] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [16] 0 0
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks
Timepoint [16] 0 0
26, 52, and 78 weeks
Secondary outcome [17] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes
Timepoint [17] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [18] 0 0
Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks
Timepoint [18] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [19] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin
Timepoint [19] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [20] 0 0
Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks
Timepoint [20] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [21] 0 0
Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate
Timepoint [21] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [22] 0 0
Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure
Timepoint [22] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [23] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate
Timepoint [23] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [24] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Timepoint [24] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [25] 0 0
Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)
Timepoint [25] 0 0
Baseline, 26, 52, 78, and 83 weeks

Eligibility
Key inclusion criteria
* Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)

1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
* Accept treatment with metformin and glimepiride throughout the study, as per protocol
* Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
* Stable weight for 3 months prior to screening
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
* Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test 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
* HbA1c equal to or less than 6.5 at randomization
* Chronic insulin use
* Taking drugs to promote weight loss by prescription or over the counter
* Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
* Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
* Acute or chronic pancreatitis of any form
* Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
* History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
* A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
* Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
* Organ transplant except cornea
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study
* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

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
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
810
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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. - Wollongong
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. - Brisbane
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. - Keswick
Recruitment hospital [4] 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. - East Ringwood
Recruitment hospital [5] 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. - Heidelberg
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
5035 - Keswick
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Mendoza
Country [5] 0 0
Belgium
State/province [5] 0 0
Gribomont
Country [6] 0 0
Belgium
State/province [6] 0 0
Halen
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Brazil
State/province [8] 0 0
Joinville
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Croatia
State/province [16] 0 0
Osijek
Country [17] 0 0
Croatia
State/province [17] 0 0
Slavonski Brod
Country [18] 0 0
Croatia
State/province [18] 0 0
Zagreb
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Holesov
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prague
Country [21] 0 0
France
State/province [21] 0 0
Corbeil-Essonnes
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Tours
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Mako
Country [29] 0 0
Hungary
State/province [29] 0 0
Mosonmagyarovar
Country [30] 0 0
Hungary
State/province [30] 0 0
Szekesfehervar
Country [31] 0 0
India
State/province [31] 0 0
Aligarh
Country [32] 0 0
India
State/province [32] 0 0
Bangalore
Country [33] 0 0
India
State/province [33] 0 0
Chennai
Country [34] 0 0
India
State/province [34] 0 0
Indore
Country [35] 0 0
India
State/province [35] 0 0
Jaipur
Country [36] 0 0
India
State/province [36] 0 0
Mumbai
Country [37] 0 0
India
State/province [37] 0 0
Patna
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Bucheon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Ilsan
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Pusan
Country [43] 0 0
Mexico
State/province [43] 0 0
Coatzacoalcos
Country [44] 0 0
Mexico
State/province [44] 0 0
Cuernavaca
Country [45] 0 0
Mexico
State/province [45] 0 0
Guadalajara
Country [46] 0 0
Mexico
State/province [46] 0 0
Monterrey
Country [47] 0 0
Poland
State/province [47] 0 0
Bialystok
Country [48] 0 0
Poland
State/province [48] 0 0
Bydogoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Krakow
Country [50] 0 0
Poland
State/province [50] 0 0
Szczecin
Country [51] 0 0
Poland
State/province [51] 0 0
Warsaw
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Romania
State/province [53] 0 0
Baia Mare
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Galati
Country [56] 0 0
Romania
State/province [56] 0 0
Oradea
Country [57] 0 0
Slovakia
State/province [57] 0 0
Kosice
Country [58] 0 0
Spain
State/province [58] 0 0
Alicante
Country [59] 0 0
Spain
State/province [59] 0 0
Avila
Country [60] 0 0
Spain
State/province [60] 0 0
Palencia
Country [61] 0 0
Spain
State/province [61] 0 0
Requena
Country [62] 0 0
Sweden
State/province [62] 0 0
Göteborg
Country [63] 0 0
Sweden
State/province [63] 0 0
Helsingborg
Country [64] 0 0
Sweden
State/province [64] 0 0
Lund
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Taiwan
State/province [66] 0 0
Chiayi City
Country [67] 0 0
Taiwan
State/province [67] 0 0
Kaohsiung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Tainan
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taipei
Country [70] 0 0
Taiwan
State/province [70] 0 0
Tao-Yuan
Country [71] 0 0
Taiwan
State/province [71] 0 0
Yung-Kang, Tainan

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/NCT01075282