We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01059825
First Posted: February 1, 2010
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: Sitagliptin 100 mg Drug: Placebo to Sitagliptin Drug: Metformin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:
  • Baseline Hemoglobin A1c (HbA1c) [ Time Frame: Baseline ]
    HbA1c is measured as percent.

  • Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline and Week 12 ]
    HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).


Secondary Outcome Measures:
  • Change From Baseline in HbA1C at Week 2 [ Time Frame: Baseline and Week 2 ]
    HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  • Change From Baseline in HbA1c at Week 4 [ Time Frame: Baseline and Week 4 ]
    HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  • Change From Baseline in HbA1c at Week 8 [ Time Frame: Baseline and Week 8 ]
    HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  • Baseline Body Weight [ Time Frame: Baseline ]
  • Percent Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline and Week 12 ]
    The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  • Percent Change From Baseline in Body Weight at Week 2 [ Time Frame: Baseline and Week 2 ]
    The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  • Percent Change From Baseline in Body Weight at Week 4 [ Time Frame: Baseline and Week 4 ]
    The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  • Percent Change From Baseline in Body Weight at Week 8 [ Time Frame: Baseline and Week 8 ]
    The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  • Baseline Systolic Blood Pressure [ Time Frame: Baseline ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

  • Change From Baseline in Systolic Blood Pressure at Week 12 [ Time Frame: Baseline and Week 12 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  • Change From Baseline in Systolic Blood Pressure at Week 2 [ Time Frame: Baseline and Week 2 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  • Change From Baseline in Systolic Blood Pressure at Week 4 [ Time Frame: Baseline and Week 4 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  • Change From Baseline in Systolic Blood Pressure at Week 8 [ Time Frame: Baseline and Week 8 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  • Baseline Diastolic Blood Pressure [ Time Frame: Baseline ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

  • Change From Baseline in Diastolic Blood Pressure at Week 12 [ Time Frame: Baseline and Week 12 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  • Change From Baseline in Diastolic Blood Pressure at Week 2 [ Time Frame: Baseline and Week 2 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  • Change From Baseline in Diastolic Blood Pressure at Week 4 [ Time Frame: Baseline and Week 4 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  • Change From Baseline in Diastolic Blood Pressure at Week 8 [ Time Frame: Baseline and Week 8 ]
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  • Baseline Fasting Plasma Glucose [ Time Frame: Baseline ]
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline and Week 12 ]
    The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Change From Baseline in Fasting Plasma Glucose at Week 2 [ Time Frame: Baseline and Week 2 ]
    The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Change From Baseline in Fasting Plasma Glucose at Week 4 [ Time Frame: Baseline and Week 4 ]
    The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Change From Baseline in Fasting Plasma Glucose at Week 8 [ Time Frame: Baseline and Week 8 ]
    The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Percentage of Participants Achieving HbA1c <7% at Week 12 [ Time Frame: Week 12 ]
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Percentage of Participants Achieving HbA1C <6.5% at Week 12 [ Time Frame: Week 12 ]
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  • Number of Participants Who Experienced an Advere Event (AE) [ Time Frame: Up to 98 days ]
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.

  • Number of Participants Who Discontinued Study Medication Due to an AE [ Time Frame: Up to 84 days ]
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.


Enrollment: 375
Actual Study Start Date: February 24, 2010
Study Completion Date: January 20, 2011
Primary Completion Date: January 20, 2011 (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, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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, matching placebo to 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, matching placebo to 100 mg, once daily for 84 days
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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, matching placebo to 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, matching placebo to 100 mg, once daily for 84 days
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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, matching placebo to 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, matching placebo to 100 mg, once daily for 84 days
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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, matching placebo to 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, matching placebo to 100 mg, once daily for 84 days
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Drug: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®
Drug: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059825


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01059825     History of Changes
Other Study ID Numbers: 8835-016
B1521006 ( Other Identifier: Pfizer protocol number )
2009-017131-18 ( EudraCT Number )
First Submitted: January 29, 2010
First Posted: February 1, 2010
Results First Submitted: September 8, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action