Phase 3
N=30
Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin
Type II; Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02984644 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Measurement of the Change in Plasma Glucose (mg/dL): Study 1 — -29; -17 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
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of the Change in Plasma Glucose (mg/dL): Study 1 |
-29; -17 | — |
| PRIMARY Change in Plasma Glucose Measurement Using a Glucose Clamp: Study 2 |
3; 1 | — |
| PRIMARY Change in Plasma Glucose Using a Pancreatic Clamp: Study 3 |
-30; -7 | — |
| PRIMARY Change in EGP: Study 1 |
0.10; -0.56 | — |
| PRIMARY Change in EGP With Glucose Clamp: Study 2 |
-0.57; -1.28 | — |
| PRIMARY Change in EGP With Pancreatic Clamp: Study 3 |
-0.23; -0.48 | — |
| SECONDARY Change in Plasma Insulin Concentrations: Study 1 |
5; 3 | — |
| SECONDARY Plasma Insulin Concentrations During Measurement of EGP Plus Glucose Clamp: Study 2 |
0; 0 | — |
| SECONDARY Change in Plasma Insulin While Using Pancreatic Clamp: Study 3 |
2; 0 | — |
| SECONDARY Change in Glucagon: Study 1 |
5; -1 | — |
| SECONDARY Change in Glucagon Using Glucose Clamp: Study 2 |
-6; -7 | — |
| SECONDARY Change in Glucagon Using Pancreatic Clamp: Study 3 |
-1; -2 | — |
Summary
To determine the role of plasma glucagon and insulin in the rise of endogenous glucose production (EGP) following the SGLT2 inhibition.
Eligibility Criteria
Inclusion Criteria
- T2DM according to ADA criteria-HbA1C 1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded
Data sourced from ClinicalTrials.gov (NCT02984644). 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.