Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: HCTZ 12.5mg; Drug: Ertugliflozin 25 mg; Drug: Ertugliflozin 1 mg; Drug: Placebo to HCTZ; Drug: Placebo to Ertuglilflozin 1 or 5 mg; Drug: Placebo to ertuglilflozin 25 mg; Drug: Ertugliflozin 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096667

MK-8835-042 (Other Identifier)

8835-042

B1521004 (Other Identifier)

Details and patient eligibility

About

MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.

Enrollment: 194 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with type 2 diabetes and hypertension
• Medically stable
• On at least 1 (and up to 2) oral diabetes drugs
• And up to 2 medicines for blood pressure control

Exclusion criteria

• Participants with type 1 diabetes
• Heart attack
• Stroke
• Uncontrolled blood pressure
• Significant kidney disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.

Treatment:

Drug: Placebo to HCTZ

Drug: Placebo to Ertuglilflozin 1 or 5 mg

Drug: Placebo to ertuglilflozin 25 mg

Ertugliflozin 1 mg

Experimental group

Description:

Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days

Treatment:

Drug: Placebo to HCTZ

Drug: Ertugliflozin 1 mg

Drug: Placebo to ertuglilflozin 25 mg

Ertugliflozin 5 mg

Experimental group

Description:

Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days

Treatment:

Drug: Placebo to HCTZ

Drug: Ertugliflozin 5 mg

Drug: Placebo to ertuglilflozin 25 mg

Ertugliflozin 25 mg

Experimental group

Description:

Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days

Treatment:

Drug: Placebo to HCTZ

Drug: Ertugliflozin 25 mg

Drug: Placebo to Ertuglilflozin 1 or 5 mg

HCTZ 12.5mg

Active Comparator group

Description:

HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days

Treatment:

Drug: Placebo to Ertuglilflozin 1 or 5 mg

Drug: HCTZ 12.5mg

Drug: Placebo to ertuglilflozin 25 mg