Last updated: 11/07/2018 12:19:46
Indirect Comparison of Albiglutide and Exenatide QW using the Bucher method
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Indirect Comparison of Albiglutide and Exenatide QW using the Bucher method
Trial description: An indirect comparison of efficacy on blood glucose control, as measured by change from baseline in HbA1c, with albiglutide 50mg once weekly and exenatide 2mg once weekly. The objective is to determine whether albiglutide 50mg and exenatide 2mg are of comparable efficacy. The indirect comparison will be conducted using two studies: HARMONY 7, a 32-week, randomised, open-label study in adults with type 2 diabetes inadequately controlled on oral therapy, comparing albiglutide 50mg once weekly and liraglutide 1.8mg once daily; and DURATION 6: a 26 week, open-label, randomised study in adults with type 2 diabetes uncontrolled with oral antihyperglycaemic drugs, comparing once weekly exenatide 2mg and once-daily liraglutide 1.8 mg. The analysis will be conducted using the Bucher method, a technique for indirectly comparing two treatments that have both been compared to a third treatment. In this case, liraglutide 1.8mg once daily is the common comparator.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Blood glucose control measured as the change from baseline in HbA1c
Timeframe: 32 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Alan Martin, Daniel Parks. Indirect Comparison of Hb1Ac treatment effect with albiglutide and exenatide QW suing the Bucher Method. Diabetes Metab Syndrome Obes. 2016;9:163-168.
- Inclusion Criteria:
- Patients with type 2 diabetes
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Patients with type 2 diabetes
- Aged 18 or over
- Diabetes not well controlled with metformin or metformion and a sulfonyurea Exclusion criteria:
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-23-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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