SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-23

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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The inhibition of the renal (kidney) SGLT2 transporter has proven to be an effective therapeutic intervention to reduce plasma glucose levels (amount of glucose found in the liquid part of blood) and HbA1c.

In this study, the investigators hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. The investigators will examine whether the signal for the increase in EGP (endogenous glucose production) caused by glucosuria (an excess of sugar in the urine, typically associated with diabetes) is mediated via the decrease in plasma glucose and insulin concentrations, or by the increase in plasma glucagon concentration.

Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dapagliflozin

20 subjects will receive dapagliflozin 10mg

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

SGLT2 inhibitor (dapagliflozin)

Placebo

10 subjects will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator

Interventions

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Dapagliflozin

SGLT2 inhibitor (dapagliflozin)

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type DRUG

Other Intervention Names

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Farxiga

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No