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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01059825
First received: January 29, 2010
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin 1 mg
Drug: Ertugliflozin 5 mg
Drug: Ertugliflozin 25 mg
Drug: 100 mg sitagliptin
Drug: Placebo to Sitagliptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in Hemoglobin A1C (HbA1C) at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Body Weight at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
  • Change from Baseline in Systolic and Diastolic Blood Pressure at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Plasma Glucose at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HbA1C <7% and <6.5% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Number of participants who experienced an advere event (AE) [ Time Frame: Up to 98 days ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study medication due to an AE [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]

Enrollment: 328
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, 100 mg, once daily for 84 days
Experimental: Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, 100 mg, once daily for 84 days
Experimental: Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, 100 mg, once daily for 84 days
Experimental: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, 100 mg, once daily for 84 days
Experimental: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, 100 mg, once daily for 84 days
Active Comparator: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Drug: Placebo to Ertugliflozin
Tablet(s), 1 or 2, 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: 100 mg sitagliptin
Tablet, 100 mg, once daily for 84 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 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/m2

Exclusion Criteria:

  • Patients with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059825

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01059825     History of Changes
Other Study ID Numbers: 8835-016
Study First Received: January 29, 2010
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Phase 2
safety and efficacy study with ertugliflozin (PF-04971729, MK-8835)
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on August 03, 2015