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 A1cNumber 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 GlucoseChange 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
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