Clinical Trials List
Protocol NumberMK-8835-002
NCT Number(ClinicalTrials.gov Identfier)NCT01999218
2014-06-01 - 2016-08-31
Phase III
Terminated5
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
-
Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
-
Sponsor
Merck Sharp & Dohme Corp.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 鄭凱鴻 Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jin-Shang Wu Division of Family Medicine
- Yi-Ching Yang Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Treatment of Type 2 Diabetes Mellitus (T2DM)
Objectives
This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.
Test Drug
Ertugliflozin
Active Ingredient
Ertugliflozin
Dosage Form
Oral Administration. ( Film Coated Tablets)
Dosage
5/ 10
Endpoints
Primary Outcome Measures :
Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach [ Time Frame: Baseline and Week 52 ]
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106 [ Time Frame: Up to Week 106 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104 [ Time Frame: Up to Week 104 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach [ Time Frame: Baseline and Week 52 ]
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106 [ Time Frame: Up to Week 106 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104 [ Time Frame: Up to Week 104 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Inclution Criteria
Inclusion Criteria:
Diagnosis of T2DM in accordance to American Diabetes Association guidelines
On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
Body Mass Index (BMI) ≥18.0 kg/m^2
Male or female not of reproductive potential
If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.
Diagnosis of T2DM in accordance to American Diabetes Association guidelines
On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
Body Mass Index (BMI) ≥18.0 kg/m^2
Male or female not of reproductive potential
If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.
Exclusion Criteria
Exclusion Criteria:
History or presence of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
Known hypersensitivity or intolerance to metformin or glimepiride
On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)
History of bariatric surgery less than 12 months prior to study participation
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
Active, obstructive uropathy or an indwelling urinary catheter
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
Known history of Human Immunodeficiency Virus (HIV)
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
Any clinically significant malabsorption condition
Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
Previous randomization in a study with ertugliflozin
Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
A positive urine pregnancy test
Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
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
History or presence of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
Known hypersensitivity or intolerance to metformin or glimepiride
On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)
History of bariatric surgery less than 12 months prior to study participation
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
Active, obstructive uropathy or an indwelling urinary catheter
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
Known history of Human Immunodeficiency Virus (HIV)
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
Any clinically significant malabsorption condition
Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
Previous randomization in a study with ertugliflozin
Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
A positive urine pregnancy test
Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
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
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
1230 participants
