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: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in Hepatic Glucose Production (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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ralph DeFronzo; The University of Texas Health Science Center at San Antonio
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Canagliflozin; Incretins; Liraglutide

Criteria

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 with or without sulfonylurea

• 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 estimated Glomerular Filtration Rate (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