Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo to Ertugliflozin; Drug: Metformin; Drug: Ertugliflozin 1 mg; Drug: Sitagliptin 100 mg; Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 25 mg; Drug: Placebo to Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01059825

B1521006 (Other Identifier)

8835-016

2009-017131-18 (EudraCT Number)

Details and patient eligibility

About

MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

Enrollment: 375 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2

Exclusion criteria

• Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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375 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Metformin

Drug: Placebo to Sitagliptin

Ertugliflozin 1 mg

Experimental group

Description:

Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Metformin

Drug: Ertugliflozin 1 mg

Drug: Placebo to Sitagliptin

Ertugliflozin 5 mg

Experimental group

Description:

Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Metformin

Drug: Placebo to Sitagliptin

Drug: Ertugliflozin 5 mg

Ertugliflozin 10 mg

Experimental group

Description:

Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Metformin

Drug: Placebo to Sitagliptin

Drug: Ertugliflozin 5 mg

Ertugliflozin 25 mg

Experimental group

Description:

Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Ertugliflozin 25 mg

Drug: Metformin

Drug: Placebo to Sitagliptin

Sitagliptin 100 mg

Active Comparator group

Description:

Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days

Treatment:

Drug: Placebo to Ertugliflozin

Drug: Sitagliptin 100 mg

Drug: Metformin