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Proposal 1907

Title of the Proposed Research

The development of a disease progression model to describe the long-term effects of anti-diabetic medications on Hemoglobin A1C

Lead Researcher

Mohammad Saleh

Affiliation

The University of Jordan

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

4 October 2017

Lay Summary

Hemoglobin A1c is a form of hemoglobin that is used for checking blood sugar control in diabetic patients. Different anti-diabetic medications are available for the management of type 2 diabetes. The efficacy of these medications in lowering blood sugar is assessed by serial measurements of Hemoglobin A1c.

The objective of the present project is to describe the change in Hemoglobin A1c following anti-diabetic drug therapy. We will use specialized mathematical equations to quantify the effect of various anti-diabetic medications on Hemoglobin A1c level. We also plan to identify patients characteristics associated with poor response to anti-diabetic medications.

We plan to explore several anti-diabetic medications including: Liraglutide, Metformin, Albiglutide, Rosiglitazone, and Sitagliptin.

Study Data Provided

GSK-49653/231: A long term, open label, randomised study in patients with type 2 diabetes, comparing the combination of rosiglitazone and either metformin or sulfonylurea with metformin plus sulfonylurea on cardiovascular endpoints and glycaemia
GSK-GLP114179: A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
GSK-GLP114130: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
GSK-GLP112753: A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
GSK-GLP112757: A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and with Metformin plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
GSK-GLP112756: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.