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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00099619




Registration number
NCT00099619
Ethics application status
Date submitted
17/12/2004
Date registered
20/12/2004
Date last updated
23/02/2015

Titles & IDs
Public title
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Scientific title
Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy
Secondary ID [1] 0 0
H8O-MC-GWAO
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/insulin glargine
Treatment: Drugs - insulin glargine/exenatide

Experimental: exenatide/insulin glargine - Arm that first receives exenatide, then crosses over to insulin glargine

Experimental: Insulin glargine/exenatide - Arm that first receives insulin glargine, then crosses over to exenatide


Treatment: Drugs: exenatide/insulin glargine
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels

Treatment: Drugs: insulin glargine/exenatide
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
Timepoint [1] 0 0
Baseline, Week 16, Week 32
Secondary outcome [1] 0 0
Change in patient-reported outcomes from Baseline to the end of each 16-week period
Timepoint [1] 0 0
Baseline, Week 16, Week 32

Eligibility
Key inclusion criteria
Main

* Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
* HbA1c between 7.1% and 11.0%, inclusive.
* Insulin therapy should be the next appropriate step of diabetes treatment.
* Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
* Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 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
Crossover
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Westmead
Recruitment hospital [2] 0 0
Research Site - Daw Park
Recruitment hospital [3] 0 0
Research Site - Fullarton
Recruitment hospital [4] 0 0
Research Site - Box Hill
Recruitment hospital [5] 0 0
Research Site - East Ringwood
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Daw Park
Recruitment postcode(s) [3] 0 0
- Fullarton
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- East Ringwood
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Athens
Country [2] 0 0
Greece
State/province [2] 0 0
Piraeus
Country [3] 0 0
Greece
State/province [3] 0 0
Thessaloniki
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Gyula
Country [6] 0 0
Hungary
State/province [6] 0 0
Pecs
Country [7] 0 0
Hungary
State/province [7] 0 0
Veszprem
Country [8] 0 0
Hungary
State/province [8] 0 0
Zalaegerszeg
Country [9] 0 0
Italy
State/province [9] 0 0
Bari
Country [10] 0 0
Italy
State/province [10] 0 0
Bergamo
Country [11] 0 0
Italy
State/province [11] 0 0
Catania
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Perugia
Country [14] 0 0
Italy
State/province [14] 0 0
Rome
Country [15] 0 0
Mexico
State/province [15] 0 0
Jalisco
Country [16] 0 0
Mexico
State/province [16] 0 0
N.l.
Country [17] 0 0
Mexico
State/province [17] 0 0
Mexico City
Country [18] 0 0
Poland
State/province [18] 0 0
Bydgoszcz
Country [19] 0 0
Poland
State/province [19] 0 0
Gdansk
Country [20] 0 0
Poland
State/province [20] 0 0
Lublin

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
This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.
Trial website
https://clinicaltrials.gov/study/NCT00099619
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
James Malone, 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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00099619