Phase 3
Completed N=30
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
Type II Diabetes Mellitus
Source: ClinicalTrials.gov NCT02592421 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Plasma Glucose Concentration — -29.7; -17.2; 3.1; 0.9 mg/dl
◆ Published Evidence
Established
35citations · ~6 / year
Evidence Against an Important Role of Plasma Insulin and Glucagon Concentrations in the Increase in EGP Caused by SGLT2 Inhibitors.
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.
Linked Publications
-
Evidence Against an Important Role of Plasma Insulin and Glucagon Concentrations in the Increase in EGP Caused by SGLT2 Inhibitors.
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 | — |
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) and the linked publication. 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.