Clinical trial NCT01059825: Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2
safety and efficacy study with ertugliflozin (PF-04971729, MK-8835)
Type 2 diabetes mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-02-01
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Baseline Hemoglobin A1c (HbA1c)
timeFrame: Baseline
measure: Change From Baseline in HbA1c at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in HbA1C at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in HbA1c at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in HbA1c at Week 8
timeFrame: Baseline and Week 8
measure: Baseline Body Weight
timeFrame: Baseline
measure: Percent Change From Baseline in Body Weight at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Body Weight at Week 2
timeFrame: Baseline and Week 2
measure: Percent Change From Baseline in Body Weight at Week 4
timeFrame: Baseline and Week 4
measure: Percent Change From Baseline in Body Weight at Week 8
timeFrame: Baseline and Week 8
measure: Baseline Systolic Blood Pressure
timeFrame: Baseline
measure: Change From Baseline in Systolic Blood Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Systolic Blood Pressure at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Systolic Blood Pressure at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Systolic Blood Pressure at Week 8
timeFrame: Baseline and Week 8
measure: Baseline Diastolic Blood Pressure
timeFrame: Baseline
measure: Change From Baseline in Diastolic Blood Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Diastolic Blood Pressure at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Diastolic Blood Pressure at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Diastolic Blood Pressure at Week 8
timeFrame: Baseline and Week 8
measure: Baseline Fasting Plasma Glucose
timeFrame: Baseline
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Glucose at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Fasting Plasma Glucose at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Fasting Plasma Glucose at Week 8
timeFrame: Baseline and Week 8
measure: Percentage of Participants Achieving HbA1c <7% at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving HbA1C <6.5% at Week 12
timeFrame: Week 12
measure: Number of Participants Who Experienced an Advere Event (AE)
timeFrame: Up to 98 days
measure: Number of Participants Who Discontinued Study Medication Due to an AE
timeFrame: Up to 84 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.