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

NCT01059825

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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: Ertugliflozin 5 mg
    Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
  • Drug: Ertugliflozin 25 mg
    Tablet, 25 mg, once daily for 84 days
  • Drug: Sitagliptin 100 mg
    Tablet, 100 mg, once daily for 84 days
    Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®
  • 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®
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Placebo to Sitagliptin
    • Drug: Metformin
  • 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
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Ertugliflozin 1 mg
    • Drug: Placebo to Sitagliptin
    • Drug: Metformin
  • 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
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo to Sitagliptin
    • Drug: Metformin
  • Experimental: Ertugliflozin 10 mg
    Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo to Sitagliptin
    • Drug: Metformin
  • 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
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Ertugliflozin 25 mg
    • Drug: Placebo to Sitagliptin
    • Drug: Metformin
  • 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
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Sitagliptin 100 mg
    • Drug: Metformin
Publications * Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
375
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2010)
360
Actual Study Completion Date  ICMJE January 20, 2011
Actual Primary Completion Date January 20, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   India,   Korea, Republic of,   Mexico,   Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT01059825
Other Study ID Numbers  ICMJE 8835-016
B1521006 ( Other Identifier: Pfizer protocol number )
2009-017131-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialD…
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP