Last updated: 02/24/2020 17:50:13
Assessment of Patients Treated with Albiglutide – Phase 2
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Assessment of Patients Treated with Albiglutide – Phase 2
Trial description: The study will assess the effectiveness of albiglutide compared with liraglutide in a real-world setting. This study is the first comparative retrospective observational database study of patients with type 2 diabetes mellitus (T2DM) and using albiglutide since the product became available in the United States (US). This study will include adult commercial health plan members with T2DM with >= 1 pharmacy claims for albiglutide or liraglutide between 29 July 2014 and 31 December 2015.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Follow-up glycated hemoglobin (HbA1c) count
Timeframe: Up to 6 months
Change from baseline in HbA1c count
Timeframe: Baseline and up to 6 months
Number of days between index date and date of follow-up HbA1c
Timeframe: Up to 6 months
Type of glucagon-like peptide-1 (GLP-1) on index date
Timeframe: Up to 12 months
Number of pharmacy fills for glucagon-like peptide-1 (GLP-1) treatment
Timeframe: Up to 12 months
Albiglutide dose on index date and last albiglutide dose
Timeframe: Up to 12 months
Liraglutide dose on index date and last liraglutide dose
Timeframe: Up to 12 months
GLP-1 dose change in the follow-up period
Timeframe: Up to 12 months
Proportion of days covered (PDC) as a measure of compliance with index therapy.
Timeframe: Up to 12 months
Number of days for discontinuation and persistence of index therapy
Timeframe: Up to 12 months
Number of subjects with evidence of a non-index GLP-1 therapy
Timeframe: Up to 12 months
Secondary outcomes:
Not applicable
Interventions:
Drug: Albiglutide
Drug: Liraglutide
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2016-15-11
Time perspective:
Retrospective
Clinical publications:
Buysman EK, Sikirica MV, Thayer SW, Bogart M, DuCharme MC, Joshi AV. Real-World Comparison of Treatment Patterns and Effectiveness of Albiglutide and Liraglutide. J Compar Effect Res.2017;7(2):89-100.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Optum
Study date(s)
October 2016 to November 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Inclusion Criteria
- >=1 pharmacy claim for albiglutide or liraglutide between 29 July 2014 and 31 December 2015; the first fill date for albiglutide or liraglutide will be the index date and the product filled in the index date will be the index drug (albiglutide or liraglutide).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- >=1 pharmacy claim for albiglutide or liraglutide between 29 July 2014 and 31 December 2015; the first fill date for albiglutide or liraglutide will be the index date and the product filled in the index date will be the index drug (albiglutide or liraglutide).
- Age 18 or older as of the index year
- Continuous enrollment in the health plan for six months (182 days) prior to the index date (baseline period) and for six months (182 days) following and inclusive of the index date (follow-up period)
- >=1 medical claim with a T2DM diagnosis in any diagnosis position during the baseline period through the end of follow-up (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnosis codes 250.x0, 250.x2; for claims with service dates occurring on or after 01 October 2015 (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] codes are provided in the accompanying Excel file), OR >=1 pharmacy claim for an oral antidiabetic (OAD) during the baseline period through the end of follow-up HbA1c Subset analysis requirements:
- >=1 HbA1c result in the laboratory results data during the baseline period through the index date + 7 days
- >=1 HbA1c result between 30 days prior to and following the 6-month follow up period (index date +151 through index date + 211 days) 12-month follow-up requirements:
- >=1 pharmacy claim for GLP-1 agents (albiglutide or liraglutide) between 29 July 2014 and 30 June 2015; the first fill date for albiglutide or liraglutide will be the index date and the product filled in the index date will be the index drug (albiglutide or liraglutide).
- Age 18 or older as of the index year
- Continuous enrollment in the health plan for six months (182 days) prior to the index date (baseline period) and for 12 months following and inclusive of the index date (follow-up period)
- >=1 medical claim with a T2DM diagnosis in any diagnosis position during the baseline period through the end of follow-up (ICD-9-CM diagnosis codes 250.x0, 250.x2; for claims with service dates occurring on or after 01 October 2015 ICD-10-CM codes are provided in the accompanying Excel file), OR >=1 pharmacy claim for an OAD during the baseline period through the end of follow-up Exclusion Criteria
- Pharmacy claims for GLP-1 agents (albiglutide, liraglutide, exenatide, or dulaglutide) in the baseline period.
- Evidence of type 1 diabetes mellitus (T1DM) (ICD-9-CM diagnosis codes 250.x1, 250.x3; for claims with service dates occurring on or after 01 October 2015, ICD-10-CM codes are provided in the accompanying Excel file) in any diagnosis position AND >=1 claim for insulin during the baseline period through the end of follow-up
- Evidence of pregnancy or gestational diabetes (ICD-9-CM, ICD-10-CM, and Healthcare Common Procedure Coding System [HCPCS]) in any diagnosis position during the baseline or follow-up periods
Trial location(s)
No location data available.
Study documents
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
Finalized
Actual primary completion date
2016-15-11
Actual study completion date
2016-15-11
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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