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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00099619
Ethics application status
Date submitted
17/12/2004
Date registered
17/12/2004
Date last updated
20/02/2015

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. - Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.
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 - Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires [Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument] from Baseline to the end of each 16-week exenatide or insulin glargine 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
Gender
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
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,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/show/NCT00099619
Trial related presentations / publications
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