GLP111892 Albiglutide as Add-on to Basal-Bolus Insulin Therapy in T2DM
Research type
Research Study
Full title
Study GLP111892: Albiglutide Versus Placebo as Add-on to Intensified Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
IRAS ID
161795
Contact name
Jiten Vora
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-001969-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
65177, IND Number
Duration of Study in the UK
1 years, 0 months, 19 days
Research summary
Diabetes affects an estimated 346 million people worldwide. Type 2 diabetes mellitus (T2DM) accounts for more than 90% of these cases. There is an unmet medical need for diabetes medications that restore glycemic control in patients on insulin therapy, without increasing the risks of hypoglycaemia (low blood sugar), weight gain, loss of quality of life, and poor compliance with treatment. Albiglutide has the potential to become an acceptable treatment option to be used in combination with basal-bolus insulin therapy to achieve glycosylated haemoglobin (HbA1c) control while decreasing the total daily dose of insulin, decreasing the risk of hypoglycaemia, and limiting weight gain in patients with T2DM.
Albiglutide, is approved for doctors to treat patients with type 2 diabetes in Europe and the United States. This combination with basal-bolus insulin, however, is a new use for albiglutide and has not been studied before.
The purpose of this study sponsored by GlaxoSmithKline (GSK) is to test the safety and effectiveness of a once a week injection of albiglutide against placebo (an inactive solution) when added-on to intensified basal-bolus insulin therapy (with or without metformin). Approximately 225 participants will be randomly assigned into each group.
About 450 people in 14 countries will take part in this study. Their expected participation in this study will last about 32 weeks.
The study will have 3 study periods: Screening (2 weeks), Treatment (26 weeks), and Post-treatment Follow-up (4 weeks). There will be 7 study centre visits and approximately 17 telephone calls.
Study procedures include: Medical history, physical examination, eye sight check, electrocardiogram, weight, height, blood pressure and heart rate, blood and urine tests, questionnaires and optional genetic research: Participants will be provided with a glucometer, glucometer strips and electronic diary.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1336
Date of REC Opinion
15 Dec 2014
REC opinion
Further Information Favourable Opinion