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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00641056




Registration number
NCT00641056
Ethics application status
Date submitted
17/03/2008
Date registered
21/03/2008
Date last updated
15/06/2015

Titles & IDs
Public title
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
Scientific title
Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
Secondary ID [1] 0 0
H8O-MC-GWBR (DURATION - 3)
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Exenatide Once Weekly
Treatment: Drugs - Insulin Glargine

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: Exenatide Once Weekly
subcutaneous injection, 2.0mcg, once weekly

Treatment: Drugs: Insulin Glargine
subcutaneous injection, variable dose, QD

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26 - Change in HbA1c from baseline to Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Percentage of Patients Achieving HbA1c <=7.0% at Week 26 - Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Percentage of Patients Achieving HbA1c <=6.5% at Week 26 - Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [3] 0 0
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 - Change in FSG (mmol/L) from Baseline to Week 26
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change in Body Weight (BW) From Baseline to Week 26 - Change in BW (kg) from Baseline to Week 26
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [5] 0 0
Change in Total Cholesterol From Baseline to Week 26 - Change in Total Cholesterol (mmol/L) from Baseline to Week 26
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26 - Change in HDL (mmol/L) from Baseline to Week 26
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Ratio of Triglycerides at Week 26 to Baseline - Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change in Blood Pressure From Baseline to Week 26 - Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
Timepoint [8] 0 0
Baseline, Week 26
Secondary outcome [9] 0 0
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes - Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.
Timepoint [9] 0 0
Baseline to Week 26

Eligibility
Key inclusion criteria
- Has type 2 diabetes and at least 18 years of age at screening.

- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

- Have a history of stable body weight (not varying by >5% for at least 3 months prior
to screening).

- Have been treated with metformin(Met) for at least 3 months and have been taking a
stable dose for at least 8 weeks prior to screening OR

- Have been treated with metformin(Met) for at least 3 months and have been taking a
stable dose for at least 8 weeks prior to screening and have been treated with SU for
at least 3 months and have been taking a stable dose of at least an optimally
effective dose of brand of SU for 8 weeks prior to screening.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have had a clinically significant history of cardiac disease or presence of active
cardiac disease within the year prior to inclusion in the study, including myocardial
infarction, clinically significant arrhythmia, unstable angina, moderate to severe
congestive heart failure, coronary artery bypass surgery, or angioplasty; or is
expected to require coronary artery bypass surgery or angioplasty during the course of
the study.

- Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.

- Have a history of renal transplantation or are currently receiving renal dialysis.

- Have active or untreated malignancy, or have been in remission from clinically
significant malignancy (other than basal cell or squamous cell skin cancer, in situ
carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

- Have had greater than three episodes of major hypoglycemia within 6 months prior to
screening.

- Have any contraindication for the oral antidiabetic agent which they use.

- Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly,
or excipients contained in these agents.

- Are known to have active proliferative retinopathy.

- Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat],
Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or
similar over-the-counter medications) within 3 months of screening.

- Have been treated for longer than 2 weeks with any of the following excluded
medications within 3 months prior to screening:

- Insulin

- Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])

- Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])

- Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).

- Byetta® (exenatide BID formulation)

- Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus®
[vildagliptin])

- Symlin® (pramlintide acetate).

- Have had an organ transplant.

- Have donated blood within 30 days of screening.

- Have previously completed or withdrawn from this study or any other study
investigating exenatide once weekly.

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.

- Are currently enrolled in any other clinical 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Wollongong
Recruitment hospital [2] 0 0
Research Site - Herston
Recruitment hospital [3] 0 0
Research Site - Adelaide
Recruitment hospital [4] 0 0
Research Site - Keswick
Recruitment hospital [5] 0 0
Research Site - Box Hill
Recruitment hospital [6] 0 0
Research Site - Geelong
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Keswick
Recruitment postcode(s) [5] 0 0
- Box Hill
Recruitment postcode(s) [6] 0 0
- Geelong
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Melnik
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Stodulky
Country [16] 0 0
Denmark
State/province [16] 0 0
Aalborg
Country [17] 0 0
Denmark
State/province [17] 0 0
Arhus C
Country [18] 0 0
Denmark
State/province [18] 0 0
Herlev
Country [19] 0 0
Denmark
State/province [19] 0 0
Koge
Country [20] 0 0
France
State/province [20] 0 0
Angers
Country [21] 0 0
France
State/province [21] 0 0
Corbeil Essoness
Country [22] 0 0
France
State/province [22] 0 0
Nancy
Country [23] 0 0
France
State/province [23] 0 0
Nanterre
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Germany
State/province [25] 0 0
Bad Mergentheim
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Falkensee
Country [29] 0 0
Germany
State/province [29] 0 0
Fulda
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg-Othmarschen
Country [31] 0 0
Germany
State/province [31] 0 0
Munster
Country [32] 0 0
Germany
State/province [32] 0 0
Rothenburg an der fulda
Country [33] 0 0
Germany
State/province [33] 0 0
Speyer
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Thessaloniki
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Eger
Country [38] 0 0
Hungary
State/province [38] 0 0
Gyula
Country [39] 0 0
Hungary
State/province [39] 0 0
Pecs
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gyeonggi-Do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Mexico
State/province [42] 0 0
Merida
Country [43] 0 0
Mexico
State/province [43] 0 0
Mexico City
Country [44] 0 0
Mexico
State/province [44] 0 0
Tampico
Country [45] 0 0
Mexico
State/province [45] 0 0
Tijuana
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Gouda
Country [48] 0 0
Netherlands
State/province [48] 0 0
Hoogeveen
Country [49] 0 0
Netherlands
State/province [49] 0 0
Rotterdam
Country [50] 0 0
Netherlands
State/province [50] 0 0
Zwijndrecht
Country [51] 0 0
Netherlands
State/province [51] 0 0
Zwolle
Country [52] 0 0
Puerto Rico
State/province [52] 0 0
Caguas
Country [53] 0 0
Puerto Rico
State/province [53] 0 0
Yabucoa
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Rostov-on-Don
Country [56] 0 0
Russian Federation
State/province [56] 0 0
St. Petersburg
Country [57] 0 0
Spain
State/province [57] 0 0
Alicante
Country [58] 0 0
Spain
State/province [58] 0 0
Alzira-Valencia
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Bilbao
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Malaga
Country [63] 0 0
Spain
State/province [63] 0 0
Teruel
Country [64] 0 0
Taiwan
State/province [64] 0 0
Chia-Yi
Country [65] 0 0
Taiwan
State/province [65] 0 0
Tainan County
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and
insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen
et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and
tolerability.
Trial website
https://clinicaltrials.gov/show/NCT00641056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer, MD
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

Summary results
Other publications