200977 Study of Albiglutide in patients with Type 2 Diabetes Mellitus
Research type
Research Study
Full title
Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study
IRAS ID
163262
Contact name
Mimi Chen
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-001821-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
65177, IND Number
Duration of Study in the UK
1 years, 0 months, 28 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 glycaemic 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 aims to treat patients with T2DM along with diet and exercise, as a treatment on its own or in a combination with other therapies to improve glucose control. Information from this study will test if albiglutide is a good option instead of insulin lispro (insulin used before each main meal) in patients with T2DM that cannot be well controlled with use of a combination of insulin lispro and long acting insulin (insulin glargine).
In patients treated with combination of insulin lispro plus insulin glargine, albiglutide has the potential to maintain glycaemic control with less hypoglycaemia and less weight gain, while demonstrating a reduced total daily insulin requirement and reduced number of weekly injections.Albiglutide, is approved for doctors to treat patients with T2DM in Europe and the United States. The combination of albiglutide plus insulin glargine is also approved, but not as a replacement for insulin lispro.
The purpose of this study sponsored by GlaxoSmithKline (GSK) is to test the safety and effectiveness of a once a week injection of albiglutide when taken with insulin glargine as a replacement for insulin lispro. The combination of albiglutide plus insulin glargine will be compared with daily injections of insulin lispro and insulin glargine. Approximately 397 participants will be randomly assigned into each group. Expected participation will last 36 weeks.
Study procedures include: Medical history, physical examination, eye test, electrocardiogram, weight, height, blood pressure and heart rate, blood and urine tests, questionnaires.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1337
Date of REC Opinion
15 Dec 2014
REC opinion
Further Information Favourable Opinion