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Last Updated: May 31, 2020

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CLINICAL TRIALS PROFILE FOR AVANDAMET

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All Clinical Trials for Avandamet

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00069836 Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies. Completed GlaxoSmithKline Phase 3 2003-10-01 This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
NCT00110851 Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet) Completed Wellstat Therapeutics Phase 2 2005-04-01 This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).
NCT00116922 A Lifestyle and Combination Medication Therapy Diabetes Prevention Study Completed University of Western Ontario, Canada Phase 3 2004-06-01 It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00116922 A Lifestyle and Combination Medication Therapy Diabetes Prevention Study Completed Samuel Lunenfeld Research Institute, Mount Sinai Hospital Phase 3 2004-06-01 It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00131664 Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study) Completed GlaxoSmithKline Phase 3 2005-09-01 The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00131664 Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study) Completed Canadian Heart Research Centre Phase 3 2005-09-01 The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00241605 AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus Completed GlaxoSmithKline Phase 4 2003-06-01 This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Avandamet

Condition Name

Condition Name for Avandamet
Intervention Trials
Diabetes Mellitus, Type 2 6
Type 2 Diabetes Mellitus 2
Diabetes 2
Impaired Glucose Tolerance 1
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Condition MeSH

Condition MeSH for Avandamet
Intervention Trials
Diabetes Mellitus, Type 2 9
Diabetes Mellitus 9
Non-alcoholic Fatty Liver Disease 1
Coronary Artery Disease 1
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Clinical Trial Locations for Avandamet

Trials by Country

Trials by Country for Avandamet
Location Trials
United States 75
Germany 22
Italy 9
Mexico 8
Canada 7
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Trials by US State

Trials by US State for Avandamet
Location Trials
Texas 5
Pennsylvania 3
Oregon 3
North Carolina 3
Florida 3
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Clinical Trial Progress for Avandamet

Clinical Trial Phase

Clinical Trial Phase for Avandamet
Clinical Trial Phase Trials
Phase 4 3
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Avandamet
Clinical Trial Phase Trials
Completed 12
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Avandamet

Sponsor Name

Sponsor Name for Avandamet
Sponsor Trials
GlaxoSmithKline 8
Brooke Army Medical Center 1
Samuel Lunenfeld Research Institute, Mount Sinai Hospital 1
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Sponsor Type

Sponsor Type for Avandamet
Sponsor Trials
Industry 10
Other 9
U.S. Fed 1
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