Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:1/13/2019
Start Date:November 2014
End Date:March 31, 2019

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Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can
prevent the increase in HGP following institution of canagliflozin therapy and produce an
additive or even synergistic effect to lower the plasma glucose concentration and A1c.

Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin
can produce an additive, or even synergistic, effect to promote weight loss and reduction in
hepatic and visceral fat content.

Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin
can produce an additive or even synergistic effect to reduce systolic/diastolic blood
pressure and 24-hour integrated blood pressure.

Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can
prevent the increase in HGP following institution of canagliflozin therapy and produce an
additive or even synergistic effect to lower the plasma glucose concentration and A1c. We
will examine this hypothesis by comparing the effect of administration of liraglutide alone,
canagliflozin alone, and the combination of liraglutide plus canagliflozin on:(i) the rate of
HGP; (ii) decrease in fasting plasma glucose concentration; (iii) counter-regulatory hormone
response and (iv) A1c. We anticipate that the addition of liraglutide to canagliflozin will
prevent the increase in plasma glucagon concentration, augment insulin secretion, and
blunt/block the increase in HGP in response to canagliflozin, resulting in a greater decrease
in fasting plasma glucose concentration and A1c than observed with each therapy alone.

Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin
can produce an additive, or even synergistic, effect to promote weight loss and reduction in
hepatic and visceral fat content.

Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin
can produce an additive or even synergistic effect to reduce systolic/diastolic blood
pressure and 24-hour integrated blood pressure.

Inclusion Criteria:

- Male and female subjects between the ages of 18-70

- Subjects with Type 2 Diabetes Mellitus (T2DM)

- Drug naïve or on stable dose (more than 3 months) of metformin

- Have an HbA1c levels ≥7.0% and <10.0%

- Stable weight (± 3 lbs) over the preceding 3 months

Exclusion Criteria:

- Subjects taking drugs known to affect glucose metabolism (other than metformin) will
be excluded.

- Individuals with evidence of proliferative diabetic retinopathy or plasma creatinine
>1.4 females or >1.5 males or eGFR< 60 ml/min.172m2 will be excluded

- Unstable body weight (change of greater than ±3 lbs over the preceding 3 months)

- Participates in excessively heavy exercise program
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Ralph A DeFronzo, MD
Phone: 210-567-6691
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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San Antonio, TX
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