Phase 3
N=30
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
Type II Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02592421 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Change in Plasma Glucose Concentration — -29.7; -17.2; 3.1; 0.9 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Glucose Concentration |
-29.7; -17.2; 3.1; 0.9; -30.3; -2.3 | — |
| PRIMARY Change in Endogenous Glucose Production (EGP) |
0.1; -0.56; -0.57; -1.28; -0.23; -0.48 | — |
| SECONDARY Change in Plasma Insulin During Measurement of EGP |
5; 3; 0; 0; 2; 0 | — |
| SECONDARY Change in Glucagon During EGP Measurement |
5; -1; -6; -7; -1; -2 | — |
Summary
In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP following SGLT2 inhibition.
Eligibility Criteria
Inclusion Criteria
- T2DM subjects
- 18 - 70 yrs old
- BMI = 25-45 kg/m2
- Must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- HbA1c 1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg
Data sourced from ClinicalTrials.gov (NCT02592421). 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.