N/A
Completed N=45
Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT02324842 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
May 2019
Primary outcomePrimary: HbA1c at 4 Months — 8.2; 8.4; 8.1 percentage glycated hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c at 4 Months |
8.2; 8.4; 8.1 | — |
| PRIMARY Fasting Plasma Glucose (FPG) at 4 Months |
174; 177; 180 | — |
| SECONDARY Body Mass Index (BMI) at 4 Months |
34.8; 35.1; 34.8 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02324842). 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. Informational only — not medical advice.