Phase 2
Completed N=375
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
Source: ClinicalTrials.gov NCT01059825 ↗Enrolled (actual)
375
Serious AEs
0.9%
Results posted
Oct 2017
Primary outcomePrimary: Baseline Hemoglobin A1c (HbA1c) — 8.08; 8.01; 7.88; 8.13 Percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Hemoglobin A1c (HbA1c) |
8.08; 8.01; 7.88; 8.13; 8.30; 8.24 | — |
| PRIMARY Change From Baseline in HbA1c at Week 12 |
-0.11; -0.56; -0.80; -0.73; -0.83; -0.87 | 0.002 sig |
| SECONDARY Change From Baseline in HbA1C at Week 2 |
0.00; -0.14; -0.29; -0.22; -0.17; -0.26 | 0.049 sig |
| SECONDARY Change From Baseline in HbA1c at Week 4 |
-0.04; -0.40; -0.49; -0.48; -0.40; -0.48 | 0.000 sig |
| SECONDARY Change From Baseline in HbA1c at Week 8 |
-0.10; -0.57; -0.76; -0.73; -0.75; -0.77 | 0.000 sig |
| SECONDARY Baseline Body Weight |
83.78; 83.44; 85.74; 82.28; 81.81; 85.52 | — |
| SECONDARY Percent Change From Baseline in Body Weight at Week 12 |
-0.75; -1.90; -2.50; -2.90; -2.66; -0.30 | 0.007 sig |
| SECONDARY Percent Change From Baseline in Body Weight at Week 2 |
-0.24; -0.65; -1.36; -1.14; -1.11; 0.21 | 0.043 sig |
| SECONDARY Percent Change From Baseline in Body Weight at Week 4 |
-0.44; -1.20; -1.76; -1.68; -1.52; 0.01 | 0.008 sig |
| SECONDARY Percent Change From Baseline in Body Weight at Week 8 |
-0.62; -1.65; -2.18; -2.30; -2.40; -0.38 | 0.003 sig |
| SECONDARY Baseline Systolic Blood Pressure |
126.7; 126.5; 127.9; 125.8; 124.9; 126.6 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 12 |
-0.55; -2.69; -4.03; -3.43; -3.93; -1.09 | 0.163 |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 2 |
-1.93; -2.30; -4.73; -2.28; -5.39; -0.91 | 0.425 |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 4 |
-2.57; -3.94; -5.15; -5.43; -3.33; -3.32 | 0.234 |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 8 |
-0.44; -1.53; -2.85; -3.04; -3.30; -2.43 | 0.306 |
| SECONDARY Baseline Diastolic Blood Pressure |
79.14; 78.95; 78.19; 78.45; 78.61; 79.15 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 12 |
0.81; -1.12; -1.01; -3.18; -1.83; 1.68 | 0.072 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 2 |
-0.57; -1.25; -1.26; -1.97; -3.01; 0.92 | 0.289 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 4 |
-0.80; -2.47; -3.08; -2.81; -2.10; -0.51 | 0.063 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 8 |
0.80; -1.40; -0.69; -2.23; -1.20; 0.32 | 0.045 sig |
| SECONDARY Baseline Fasting Plasma Glucose |
165.3; 162.5; 156.5; 163.3; 171.3; 166.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
2.76; -18.23; -23.06; -31.47; -29.26; -17.29 | 0.000 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 2 |
5.89; -15.07; -15.68; -26.65; -16.44; -14.69 | 0.000 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 4 |
5.17; -16.91; -22.77; -27.95; -26.62; -18.00 | 0.000 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 8 |
3.82; -18.25; -24.69; -31.59; -30.99; -18.93 | 0.000 sig |
| SECONDARY Percentage of Participants Achieving HbA1c <7% at Week 12 |
15.6; 44.0; 42.9; 38.6; 36.2; 43.1 | — |
| SECONDARY Percentage of Participants Achieving HbA1C <6.5% at Week 12 |
6.7; 12.0; 20.4; 13.6; 14.9; 25.5 | — |
| SECONDARY Number of Participants Who Experienced an Advere Event (AE) |
29; 31; 30; 29; 28; 30 | — |
| SECONDARY Number of Participants Who Discontinued Study Medication Due to an AE |
1; 1; 3; 2; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01059825). 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.