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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE

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Clinical Trials for Ertugliflozin; Metformin Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT01986855 A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001) Completed Pfizer Phase 3 This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the A1C-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
NCT01986855 A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001) Completed Merck Sharp & Dohme Corp. Phase 3 This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the A1C-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
NCT01986881 Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004) Recruiting Pfizer Phase 3 A study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes a pre-defined glycemic sub-study in participants receiving background insulin with or without metformin, a pre-defined glycemic sub-study in participants receiving background sulfonylurea monotherapy, and a pre-defined sub-study in participants receiving background metformin with sulfonylurea (all fully-enrolled).
NCT01986881 Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004) Recruiting Merck Sharp & Dohme Corp. Phase 3 A study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes a pre-defined glycemic sub-study in participants receiving background insulin with or without metformin, a pre-defined glycemic sub-study in participants receiving background sulfonylurea monotherapy, and a pre-defined sub-study in participants receiving background metformin with sulfonylurea (all fully-enrolled).
NCT01999218 Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) Active, not recruiting Pfizer Phase 3 This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.
NCT01999218 Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ertugliflozin; Metformin Hydrochloride

Condition Name

Condition Name for Ertugliflozin; Metformin Hydrochloride
Intervention Trials
Type 2 Diabetes Mellitus 7
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Condition MeSH

Condition MeSH for Ertugliflozin; Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 7
Diabetes Mellitus 7
Vascular Diseases 1
Renal Insufficiency, Chronic 1
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Clinical Trial Locations for Ertugliflozin; Metformin Hydrochloride

Trials by Country

Trials by Country for Ertugliflozin; Metformin Hydrochloride
Location Trials
United States 32
Slovakia 1
Argentina 1
Thailand 1
Romania 1
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Trials by US State

Trials by US State for Ertugliflozin; Metformin Hydrochloride
Location Trials
Wisconsin 1
Massachusetts 1
Arizona 1
Arkansas 1
California 1
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Clinical Trial Progress for Ertugliflozin; Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ertugliflozin; Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Ertugliflozin; Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for Ertugliflozin; Metformin Hydrochloride

Sponsor Name

Sponsor Name for Ertugliflozin; Metformin Hydrochloride
Sponsor Trials
Merck Sharp & Dohme Corp. 7
Pfizer 7
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Sponsor Type

Sponsor Type for Ertugliflozin; Metformin Hydrochloride
Sponsor Trials
Industry 14
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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Baxter
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Daiichi Sankyo
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