Primary outcomeMean· Approximately 4 months
HbA1c at 4 Months
| Group | Value (percentage glycated hemoglobin) | Spread |
|---|---|---|
| Canagliflozin | 8.2 | 0.3 |
| Liraglutide | 8.4 | 0.3 |
| Canagliflozin Plus Liraglutide | 8.1 | 0.3 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 45 participants (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Nov 2014
- Primary completion
- 28 Mar 2018
- Completion
- 31 Mar 2019
- First posted
- 24 Dec 2014 (estimated)
- Last update posted
- 18 Dec 2019
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017201820192020
- N/A
Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients
NCT02324842Nov 2014 to 31 Mar 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CanagliflozinDrug
- LiraglutideDrug
Arms3
Active comparator
Canagliflozin
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Active comparator
liraglutide
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Active comparator
canagliflozin plus liraglutide
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Primary outcomes2
Outcomes the sponsor listed as primary.
HbA1c at 4 Months
Time frame · Approximately 4 months
Registry description
Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.
Fasting Plasma Glucose (FPG) at 4 Months
Time frame · Baseline to Approximately 4 months
Registry description
Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.
Secondary outcomes(1)
Body Mass Index (BMI) at 4 Months
Time frame · Approximately 4 months
Registry description
A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin.
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 Approximately 4 months
Fasting Plasma Glucose (FPG) at 4 Months
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Canagliflozin | 174 | 12 |
| Liraglutide | 177 | 10 |
| Canagliflozin Plus Liraglutide | 180 | 15 |
Secondary and other outcome results(6)
Secondary outcomeMean· Approximately 4 months
Body Mass Index (BMI) at 4 Months
| Group | Value (kg/m2) | Spread |
|---|---|---|
| Canagliflozin | 34.8 | 1.7 |
| Liraglutide | 35.1 | 1.1 |
| Canagliflozin Plus Liraglutide | 34.8 | 1.1 |
Other pre specified outcomeMean· Change from Baseline to Approximately 4 months
Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)
| Group | Value (index value) | Spread |
|---|---|---|
| Canagliflozin | 0.8 | 0.4 |
| Liraglutide | -0.5 | 0.4 |
| Canagliflozin Plus Liraglutide | 0.1 | 0.2 |
Other pre specified outcomeMean· At Approximately 4 months
Change in Free Plasma Insulin at the End of the Study From Baseline Value
| Group | Value (mg/ml) | Spread |
|---|---|---|
| Canagliflozin | -2 | 2 |
| Liraglutide | 2 | 2 |
| Canagliflozin Plus Liraglutide | 0.7 | 1 |
Other pre specified outcomeMean· Approximately 4 months
Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline
| Group | Value (mg/ml) | Spread |
|---|---|---|
| Canagliflozin | 12 | 6 |
| Liraglutide | -7 | 5 |
| Canagliflozin Plus Liraglutide | -5 | 5 |
Other pre specified outcomeMean· Approximately 4 months
Change in Total Body Weight at Study End Compared to Baseline
| Group | Value (kg) | Spread |
|---|---|---|
| Canagliflozin | -3.5 | 0.5 |
| Liraglutide | -1.9 | .8 |
| Canagliflozin Plus Liraglutide | -6.0 | 0.8 |
Other pre specified outcomeMean· Approximately 4 months
Change in 24-hour Blood Pressure at Study End Compared to Baseline.
| Group | Value (mmHg) | Spread |
|---|---|---|
| Canagliflozin | -5.2 | 2.2 |
| Liraglutide | 5.1 | 3.8 |
| Canagliflozin Plus Liraglutide | -14.1 | 3.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Canagliflozincanagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) | 0 / 15 | 1 / 15 | 13 / 15 |
| Liraglutideliraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 0 / 15 | 0 / 15 | 13 / 15 |
| Canagliflozin Plus Liraglutidecanagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 0 / 15 | 0 / 15 | 12 / 15 |
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
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2020
9 results
Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA1c, in Patients With Type 2 Diabetes.
Ali et al. 2020Diabetes carecited by 36
PMID 32220916PMC7411279DOI 10.2337/dc18-2460PUB-32220916
Rights unknown9 results
Indexing hint: Randomized controlled trial · 2020
12 results
Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM.
Ali et al. 2020The Journal of clinical endocrinology and metabolismcited by 10
PMID 32745202DOI 10.1210/clinem/dgaa494PUB-32745202
Rights unknown12 results
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:
* 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
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