Primary outcomeMean· Baseline to 240-300 minutes
Change in Plasma Glucose Concentration
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Dapagliflozin | -29.7 | 3 |
| Placebo | -17.2 | 2.9 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
This trial does not test a peptide that PepBank tracks.
- Measures Glucagon, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 30 participants (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- 23 Oct 2015
- Primary completion
- 1 Oct 2018
- Completion
- 31 Oct 2019
- First posted
- 30 Oct 2015 (estimated)
- Last update posted
- 17 Sept 2020
- Conditions
- Type II Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201520162017201820192020
- Ph 3
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
NCT0259242123 Oct 2015 to 31 Oct 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- DapagliflozinDrug
- PlaceboDrug
Arms2
Active comparator
Dapagliflozin
20 subjects will receive dapagliflozin 10mg
Placebo comparator
Placebo
10 subjects will receive placebo
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in Plasma Glucose Concentration
Time frame · Baseline to 240-300 minutes
Registry description
Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration
Change in Endogenous Glucose Production (EGP)
Time frame · Baseline to 240-300 minutes
Registry description
The change in endogenous glucose production is measured from baseline until the last hour of the study
Secondary outcomes(2)
Change in Plasma Insulin During Measurement of EGP
Time frame · Baseline to 240-300 minutes
Registry description
Measurement of change in plasma insulin concentration during measurement of of EGP from baseline to last hour of the study
Change in Glucagon During EGP Measurement
Time frame · Baseline to 240-300 minutes
Registry description
Measurement of change in glucagon during EGP measurement from baseline to the last hour of the study
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline to 240-300 minutes
Change in Endogenous Glucose Production (EGP)
| Group | Value (mg/kg.min) | Spread |
|---|---|---|
| Dapagliflozin | 0.1 | 0.1 |
| Placebo | -0.56 | 0.1 |
Secondary and other outcome results(2)
Secondary outcomeMean· Baseline to 240-300 minutes
Change in Plasma Insulin During Measurement of EGP
| Group | Value (microUnits/mL) | Spread |
|---|---|---|
| Dapagliflozin | 5 | 1 |
| Placebo | 3 | 1 |
Secondary outcomeMean· Baseline to 240-300 minutes
Change in Glucagon During EGP Measurement
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Dapagliflozin | 5 | 2 |
| Placebo | -1 | 2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| DapagliflozinSubjects will receive dapagliflozin 10mg Dapagliflozin: SGLT2 inhibitor (dapagliflozin) | 0 / 20 | 0 / 20 | 4 / 20 |
| PlaceboSubjects will receive placebo Placebo: Placebo Comparator | 0 / 10 | 0 / 10 | 0 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedAlatrach M, Laichuthai N, Martinez R, Agyin C, Ali AM, Al-Jobori H, Lavynenko O, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Evidence Against an Important Role of Plasma Insulin and Glucagon Concentrations in the Increase in EGP Caused by SGLT2 Inhibitors. Diabetes. 2020 Apr;69(4):681-688. doi: 10.2337/db19-0770. Epub 2020 Jan 8. PMID 31915153
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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 \<10.0%
* Stable body weight (± 3 lbs) over preceding 3 months
* Do not participate in excessively heavy exercise
Exclusion Criteria:
* Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males, or 24-hour urine albumin excretion \> 300 mg
PepBank is a research reference. Talk to a doctor before you use any peptide.