ClinicalTrials.Veeva

Menu

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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems