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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00082381
Registration number
NCT00082381
Ethics application status
Date submitted
6/05/2004
Date registered
11/05/2004
Date last updated
7/04/2015
Titles & IDs
Public title
Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
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Scientific title
Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
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Secondary ID [1]
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H8O-MC-GWAA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Exenatide (AC2993)
Treatment: Drugs - Insulin glargine
Experimental: Exenatide Arm - exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Active comparator: Insulin Glargine Arm - subcutaneous injection, once daily; forced titration to target blood glucose level
Treatment: Drugs: Exenatide (AC2993)
subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Treatment: Drugs: Insulin glargine
subcutaneous injection, once daily; forced titration to target blood glucose level
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Glycosylated Hemoglobin (HbA1c)
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Assessment method [1]
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Change in HbA1c from baseline to week 26
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Timepoint [1]
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Baseline, week 26
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Secondary outcome [1]
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Percentage of Patients Achieving HbA1c <=7%
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Assessment method [1]
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Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
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Timepoint [1]
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26 weeks
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Secondary outcome [2]
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Change in Body Weight
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Assessment method [2]
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Change in body weight from baseline to week 26
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Timepoint [2]
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Baseline, week 26
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Secondary outcome [3]
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Change in Fasting Serum Glucose
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Assessment method [3]
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Change in fasting serum glucose from baseline to week 26
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Timepoint [3]
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Baseline, week 26
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Secondary outcome [4]
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Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
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Assessment method [4]
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Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26
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Timepoint [4]
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Baseline, week 26
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Secondary outcome [5]
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Percentage of Patients With Hypoglycemic Events
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Assessment method [5]
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Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study
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Timepoint [5]
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26 weeks
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Secondary outcome [6]
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Change in Rate of Hypoglycemic Events
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Assessment method [6]
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Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26
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Timepoint [6]
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Baseline, week 26
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Eligibility
Key inclusion criteria
* Patients have been treated with a stable dose of one of the following for at least 3 months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500 to 2000 mg/day extended-release metformin) and at least an optimally effective dose of a sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components.
* HbA1c between 7.0% and 10.0%, inclusive.
* History of stable body weight (not varying by >10% for at least three months prior to screening).
* Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause)
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Minimum age
30
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
* Patients are employed by Lilly or Amylin.
* Patients have participated in this study previously or any other study using AC2993 or GLP-1 analogs.
* Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.
* Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
* Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.
* Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or excipients contained in these agents.
* Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label, in the opinion of the investigator.
* Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.3 mg/dL for females.
* Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than three times the upper limit of the reference range.
* Patients have known hemoglobinopathy or chronic anemia.
* Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
* Patients have used any prescription drug to promote weight loss within 3 months prior to screening.
* Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.
* Patients fail to satisfy the investigator of suitability to participate for any other reason.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
551
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Australian Clinical Research Centre - Miranda
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Royal North Shore Hospital - St. Leonards
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Clinical Trial and Research Unit - Wollongong
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Royal Brisbane Hospital - Brisbane
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Royal Adelaid Hospital - Adelaid
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Repatriation General Hospital - Daw Park
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SA Endocrine Clinical Research - Keswick
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Eastern Health (Box Hill Hospital) - Box Hill
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Royal Melbourne Hospital - Parkville
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2228 - Miranda
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2065 - St. Leonards
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2500 - Wollongong
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4029 - Brisbane
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5000 - Adelaid
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5041 - Daw Park
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5035 - Keswick
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3128 - Box Hill
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3050 - Parkville
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Recruitment postcode(s) [10]
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- Freemantle
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Recruitment outside Australia
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Other collaborator category [1]
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Name [1]
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Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
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Trial website
https://clinicaltrials.gov/study/NCT00082381
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Trial related presentations / publications
Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG; GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2005 Oct 18;143(8):559-69. doi: 10.7326/0003-4819-143-8-200510180-00006. Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567. Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
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Public notes
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Contacts
Principal investigator
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Chief Medical Officer, MD
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Address
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Eli Lilly and Company
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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
Type
Citations or Other Details
Journal
Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH,...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00082381
Download to PDF