NCT01059825

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

February 24, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2011

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

October 4, 2017

Completed
Last Updated

September 13, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

January 29, 2010

Results QC Date

September 8, 2017

Last Update Submit

August 15, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 2safety and efficacy study with ertugliflozin (PF-04971729, MK-8835)Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • Baseline Hemoglobin A1c (HbA1c)

    HbA1c is measured as percent.

    Baseline

  • Change From Baseline in HbA1c at 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 \[LOCF\]).

    Baseline and Week 12

Secondary Outcomes (27)

  • Change From Baseline in HbA1C at Week 2

    Baseline and Week 2

  • Change From Baseline in HbA1c at Week 4

    Baseline and Week 4

  • Change From Baseline in HbA1c at Week 8

    Baseline and Week 8

  • Baseline Body Weight

    Baseline

  • Percent Change From Baseline in Body Weight at Week 12

    Baseline and Week 12

  • +22 more secondary outcomes

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days

Drug: Placebo to ErtugliflozinDrug: Placebo to SitagliptinDrug: Metformin

Ertugliflozin 1 mg

EXPERIMENTAL

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 ErtugliflozinDrug: Ertugliflozin 1 mgDrug: Placebo to SitagliptinDrug: Metformin

Ertugliflozin 5 mg

EXPERIMENTAL

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 ErtugliflozinDrug: Ertugliflozin 5 mgDrug: Placebo to SitagliptinDrug: Metformin

Ertugliflozin 10 mg

EXPERIMENTAL

Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Drug: Placebo to ErtugliflozinDrug: Ertugliflozin 5 mgDrug: Placebo to SitagliptinDrug: Metformin

Ertugliflozin 25 mg

EXPERIMENTAL

Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days

Drug: Placebo to ErtugliflozinDrug: Ertugliflozin 25 mgDrug: Placebo to SitagliptinDrug: Metformin

Sitagliptin 100 mg

ACTIVE COMPARATOR

Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days

Drug: Placebo to ErtugliflozinDrug: Sitagliptin 100 mgDrug: Metformin

Interventions

Placebo to ErtugliflozinDRUG

Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days

Ertugliflozin 1 mgErtugliflozin 10 mgErtugliflozin 25 mgErtugliflozin 5 mgPlaceboSitagliptin 100 mg
Ertugliflozin 1 mgDRUG

Tablet, 1 mg, once daily for 84 days

Ertugliflozin 1 mg
Ertugliflozin 5 mgDRUG

Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days

Ertugliflozin 10 mgErtugliflozin 5 mg
Ertugliflozin 25 mgDRUG

Tablet, 25 mg, once daily for 84 days

Ertugliflozin 25 mg
Sitagliptin 100 mgDRUG

Tablet, 100 mg, once daily for 84 days

Also known as: Januvia®, Tesavel®, Xelevia®, Ristaben®
Sitagliptin 100 mg
Placebo to SitagliptinDRUG

Tablet, matching placebo to 100 mg, once daily for 84 days

Ertugliflozin 1 mgErtugliflozin 10 mgErtugliflozin 25 mgErtugliflozin 5 mgPlacebo
MetforminDRUG

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).

Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Ertugliflozin 1 mgErtugliflozin 10 mgErtugliflozin 25 mgErtugliflozin 5 mgPlaceboSitagliptin 100 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25754396RESULT

  • Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.

    PMID: 34213819DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ertugliflozinSitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 1, 2010

Study Start

February 24, 2010

Primary Completion

January 20, 2011

Study Completion

January 20, 2011

Last Updated

September 13, 2018

Results First Posted

October 4, 2017

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information