Phase 1
Completed N=52
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
Type 2 Diabetes Mellitus · Adult
Source: ClinicalTrials.gov NCT01054300 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Cumulative Urinary Glucose Excretion Over 0 to 24 Hours — 69.45; 70.43; 78.29; 80.54 Grams
Summary
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in adults with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Urinary Glucose Excretion Over 0 to 24 Hours |
69.45; 70.43; 78.29; 80.54 | — |
| PRIMARY Urinary Glucose Excretion by Time Period |
12.88; 14.03; 14.66; 16.34; 15.42; 17.87 | — |
| PRIMARY 24-hour Weighted Mean Plasma Glucose |
173.6; 175.7; 169.1; 170.4 | — |
| PRIMARY Weighted Mean Postprandial Plasma Glucose |
200.1; 187.2; 194.1; 189.9; 159.4; 159.8 | — |
| PRIMARY Fasting Plasma Glucose |
— | — |
| PRIMARY Fasting C-peptide |
2.82; 2.76; 3.00; 2.99 | — |
| PRIMARY Number of Participants Experiencing an Adverse Event |
5; 8; 3; 5 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an Adverse Event |
0; 1; 0; 0 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin |
131.8; 132.7; 272; 270.5 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Ertugliflozin |
19.51; 26.98; 34.80; 50.83 | — |
| PRIMARY Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin |
6.00; 1.00; 6.00; 1.00 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.
Exclusion Criteria
- Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
Data sourced from ClinicalTrials.gov (NCT01054300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.