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A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Ertugliflozin 5 mg (Drug); Ertugliflozin 15 mg (Drug); Placebo to Ertugliflozin (Drug); Glimepiride (Other); Placebo to Glimepiride (Drug); Basal Insulin (Biological); Metformin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes mellitus and inadequate glycemic control on metformin monotherapy. The primary study hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for ertugliflozin is greater than that for placebo.

Clinical Details

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change from Baseline in Hemoglobin A1c

Number of Participants Experiencing An Adverse Event (AE)

Number of Participants Discontinuing Study Treatment Due to an AE

Secondary outcome:

Change from Baseline in Fasting Plasma Glucose

Change from Baseline in Body Weight at Week 26

Number of participants with a HbA1c of <7% (53 mmol/mol) at Week 26

Change from Baseline in Systolic Blood Pressure

Change from Baseline in Diastolic Blood Pressure

Change from Baseline in Bone Mineral Density at Week 26

Change from Baseline in Bone Mineral Density at Week 52

Change from Baseline in Bone Mineral Density at Week 104

Number of participants with HbA1c <=6.5% (48 mmol/mol) at Week 26

Number of participants requiring glycemic rescue therapy up to Week 26

Time to glycemic rescue therapy up to Week 26

Change from baseline in bone biomarkers at Week 26

Change from baseline in bone biomarkers at Week 52

Change from baseline in bone biomarkers at Week 104

Detailed description: The trial includes a 13-15 week run-in period prior to randomization, and a 26-week, double-blind, placebo-controlled treatment period (Phase A) followed by a 78-week double-blind, extension period (Phase B).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of T2DM in accordance to American Diabetes Association guidelines

- Participants must be receiving metformin monotherapy for less than 8 weeks prior to

study participation or require change in their diabetes regimen to remain eligible to participate in the trial (including discontinuing anti-hyperglycemic agent [AHA] therapy) and must have a hemoglobin A1c of 7. 0 to 10. 5% (53-91 mmol/mol) after at least 8 weeks on a regimen of metformin monotherapy

Exclusion Criteria: - History of myocardial infarction, unstable angina, arterial

revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation

- A clinically significant electrocardiogram abnormality

- A history of malignancy ≤5 years prior to study participation, except for adequately

treated basal or squamous cell skin cancer or in situ cervical cancer

- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2

(SGLT2) inhibitor or glimepiride

- On a blood pressure or lipid altering medication that have not been on a stable dose

for at least 4 weeks prior to study participation

- A surgical procedure within 6 weeks prior to study participation or planned major

surgery during the trial

- Donation of blood or blood products within 6 weeks of study participation or plans to

donate blood or blood products at any time during the trial

- Pregnant or breast-feeding, or is expecting to conceive during the trial, including

14 days following the last dose of study drug

Locations and Contacts

Additional Information

Starting date: December 2013
Last updated: June 10, 2015

Page last updated: August 20, 2015

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