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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 1

- 06/11/18 - 1 modulo, 8 itemgroups, 32 elementi, 1 linguaggio

Itemgroups: Randomization; Numbers, 12-lead ECG, Electrocardiogram; Telemetry, Vital Signs, Capillary Blood Glucose measurement, Pharmacokinetic aspects; Blood, Experimental drug, Therapeutic procedure; Confirmation

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 8

- 05/10/18 - 1 modulo, 11 itemgroups, 40 elementi, 1 linguaggio

Itemgroups: 12-lead ECG, Electrocardiogram; Telemetry, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Experimental drug, Therapeutic procedure; Confirmation

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Additional Forms - Investigational Product

- 08/02/18 - 1 modulo, 1 ItemGroup, 9 elementi, 1 linguaggio

ItemGroup: Investigational Product

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Additional Forms - Investigational Product

Throughout: Adverse Events [AE_1] NCT01117584

- 31/12/16 - 1 modulo, 3 itemgroups, 39 elementi, 1 linguaggio

Itemgroups: General Information, Genital Infection, Hypoglycemia Event

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 1 Run-ln Medical History [MH 1] NCT01117584 - Visit 1 Run-In Medical History NCT01117584

- 05/12/16 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio

Itemgroups: Elements of Medical History, General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

DM-ASP1941-1941-CL-0004 NCT01071850 - Visit 7, Visit 8 DM-ASP1941-1941-CL-0004 NCT01071850

- 14/08/16 - 1 modulo, 8 itemgroups, 27 elementi, 1 linguaggio

Itemgroups: Date of Visit, Orthostatic Vital Signs, ECG: 12 Lead ECG 1, Weight, Waist and Hip Circumference, Pregnancy Test, Meal Data, Blood Sample

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 7, Visit 8

Visit 2 Baseline ADDQoL [QS_2] NCT01117584

- 12/12/16 - 1 modulo, 1 ItemGroup, 45 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 2 Baseline ADDQoL [QS_2] NCT01117584

- 12/12/16 - 1 modulo, 1 ItemGroup, 45 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Throughout: Metformin Intake [CM_3] NCT01117584

- 04/02/17 - 1 modulo, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Dose Study Drug: Accountability - Visit 6 / Kit 4 [DA_1D] NCT01117584

- 04/02/17 - 1 modulo, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Unscheduled Visit Study Drug: Accountability - Unscheduled [DA_1E] NCT01117584

- 04/02/17 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Dose Study Drug: Accountability - Visit 5 / Kit 3 [DA_1C] NCT01117584

- 04/02/17 - 1 modulo, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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