Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059825
• Other study ID #: 8835-016
• Secondary ID: B15210062009-017
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2010
• Est. completion date: January 20, 2011

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: January 20, 2011
• Est. primary completion date: January 20, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
• Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
• Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
• Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
• Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
• Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
• Metformin
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Pfizer

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Hemoglobin A1c (HbA1c)	HbA1c is measured as percent.	Baseline
Primary	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	Change From Baseline in HbA1C at Week 2	HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).	Baseline and Week 2
Secondary	Change From Baseline in HbA1c at Week 4	HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).	Baseline and Week 4
Secondary	Change From Baseline in HbA1c at Week 8	HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).	Baseline and Week 8
Secondary	Baseline Body Weight		Baseline
Secondary	Percent Change From Baseline in Body Weight at Week 12	The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).	Baseline and Week 12
Secondary	Percent Change From Baseline in Body Weight at Week 2	The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).	Baseline and Week 2
Secondary	Percent Change From Baseline in Body Weight at Week 4	The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).	Baseline and Week 4
Secondary	Percent Change From Baseline in Body Weight at Week 8	The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).	Baseline and Week 8
Secondary	Baseline Systolic Blood Pressure	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.	Baseline
Secondary	Change From Baseline in Systolic Blood Pressure at Week 12	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).	Baseline and Week 12
Secondary	Change From Baseline in Systolic Blood Pressure at Week 2	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).	Baseline and Week 2
Secondary	Change From Baseline in Systolic Blood Pressure at Week 4	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).	Baseline and Week 4
Secondary	Change From Baseline in Systolic Blood Pressure at Week 8	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).	Baseline and Week 8
Secondary	Baseline Diastolic Blood Pressure	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.	Baseline
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 12	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).	Baseline and Week 12
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 2	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).	Baseline and Week 2
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 4	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).	Baseline and Week 4
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 8	Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).	Baseline and Week 8
Secondary	Baseline Fasting Plasma Glucose	Laboratory measurements were performed after an overnight fast =8 hours in duration.	Baseline
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 12	The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast =8 hours in duration.	Baseline and Week 12
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 2	The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast =8 hours in duration.	Baseline and Week 2
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 4	The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast =8 hours in duration.	Baseline and Week 4
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 8	The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast =8 hours in duration.	Baseline and Week 8
Secondary	Percentage of Participants Achieving HbA1c <7% at Week 12	Laboratory measurements were performed after an overnight fast =8 hours in duration.	Week 12
Secondary	Percentage of Participants Achieving HbA1C <6.5% at Week 12	Laboratory measurements were performed after an overnight fast =8 hours in duration.	Week 12
Secondary	Number of Participants Who Experienced an Advere Event (AE)	An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.	Up to 98 days
Secondary	Number of Participants Who Discontinued Study Medication Due to an AE	An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.	Up to 84 days