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CompletedPhase NAResults posted

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

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

1

Recruiting sites

Enrollment

45

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-10%

Primary endpoints

HbA1cFasting glucose, changeHbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02324842
Org study ID28431754DIA4009
Secondary IDHSC20140322HUniversity of Texas Health Science Center- San Antonio

Timeline

Milestones

Study first posted2014-12-24estimated
Primary completion2018-03-28actual
Study completion2019-03-31actual
Results first posted2019-05-14actual
Last update posted2019-12-18actual
Study start2014-11 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Weight & body composition
4
Cardiometabolic biomarkers
3
Other (unclassified)
1

Weight & body composition

4 endpoints
Secondary/registry result

Body Mass Index (BMI) at 4 Months

Time frame:Approximately 4 months

descriptive, improvement

Posted result

GroupValue (mean), kg/m295% CI
Canagliflozin34.8
Liraglutide35.1
Canagliflozin Plus Liraglutide34.8
Secondary/protocol endpoint

Body Mass Index (BMI) at 4 Months

Time frame:Approximately 4 months

descriptive

Other/protocol endpoint

Change in Total Body Weight at Study End Compared to Baseline

Time frame:Approximately 4 months

Body weight, absolute change (kg)

change from baseline, improvement

Other_pre_specified/registry result

Change in Total Body Weight at Study End Compared to Baseline

Time frame:Approximately 4 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Canagliflozin-3.5
Liraglutide-1.9
Canagliflozin Plus Liraglutide-6.0

Glycemic / diabetes

8 endpoints
Primary/registry result

HbA1c at 4 Months

Time frame:Approximately 4 months

descriptive, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage glycated hemoglobin95% CI
Canagliflozin8.2
Liraglutide8.4
Canagliflozin Plus Liraglutide8.1
Primary/registry result

Fasting Plasma Glucose (FPG) at 4 Months

Time frame:Baseline to Approximately 4 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dl95% CI
Canagliflozin174
Liraglutide177
Canagliflozin Plus Liraglutide180
Primary/protocol endpoint

HbA1c at 4 Months

Time frame:Approximately 4 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Fasting Plasma Glucose (FPG) at 4 Months

Time frame:Baseline to Approximately 4 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint/low confidence

Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)

Time frame:Change from Baseline to Approximately 4 months

change from baseline, improvement

Other/protocol endpoint

Change in Free Plasma Insulin at the End of the Study From Baseline Value

Time frame:At Approximately 4 months

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)

Time frame:Change from Baseline to Approximately 4 months

change from baseline, improvement

Posted result

GroupValue (mean), index value95% CI
Canagliflozin0.8
Liraglutide-0.5
Canagliflozin Plus Liraglutide0.1
Other_pre_specified/registry result

Change in Free Plasma Insulin at the End of the Study From Baseline Value

Time frame:At Approximately 4 months

change from baseline, improvement

Posted result

GroupValue (mean), mg/ml95% CI
Canagliflozin-2
Liraglutide2
Canagliflozin Plus Liraglutide0.7

Cardiometabolic biomarkers

3 endpoints
Other/protocol endpoint

Change in 24-hour Blood Pressure at Study End Compared to Baseline.

Time frame:Approximately 4 months

change from baseline, improvement

Other_pre_specified/registry result

Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline

Time frame:Approximately 4 months

change from baseline, improvement

Posted result

GroupValue (mean), mg/ml95% CI
Canagliflozin12
Liraglutide-7
Canagliflozin Plus Liraglutide-5
Other_pre_specified/registry result

Change in 24-hour Blood Pressure at Study End Compared to Baseline.

Time frame:Approximately 4 months

change from baseline, improvement

Posted result

GroupValue (mean), mmHg95% CI
Canagliflozin-5.2
Liraglutide5.1
Canagliflozin Plus Liraglutide-14.1

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline

Time frame:Approximately 4 months

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.