GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes. A Randomized Clinical Trial

Lead sponsor

University at Buffalo

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤11%

Primary endpoint

•HbA1c, 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 IDNCT02518945

Org study ID1969

Timeline

Milestones

Study first posted2015-08-10estimated

Last update posted2024-01-24actual

Results first posted2024-01-24actual

Study start2015-08actual (month precision)

Primary completion2015-12actual (month precision)

Study completion2016-04actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 1 diabetes mellitus: Fasting c-peptide < 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis and treatment with liraglutide at maximal tolerated doses for at least 6 months prior to start of the study.

•Willing to use a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily

•HbA1c of less than or equal to 11%.

•Well versed with carbohydrate counting

•Age 18-75 years

Exclusion criteria

•Type 1 diabetes for less than 12 months.

•Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks

•Hepatic disease (transaminase > 3 times normal) or cirrhosis

•ESRD on hemodialysis; and or e-GFR less than 30 ml/min/1.73m2

•HIV or Hepatitis C positive status

•Participation in any other concurrent clinical trial

•Any other life-threatening, non-cardiac disease

•Use of an investigational agent or therapeutic regimen within 30 days of study

•History of pancreatitis

•Pregnancy

•Inability to give informed consent

•History of gastroparesis

•History of medullary thyroid carcinoma or MEN 2 syndrome

•Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer

•Women of childbearing potential who are not using adequate contraception

•Women who are pregnant

•History of serious hypersensitivity reaction to these agents.

Endpoints (14)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Placebo	0.7	—
Active Drugs	-1.9	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), % HbA1c	95% CI
Placebo	0	—
Active Drugs	-0.66	—

Primary/protocol endpoint

Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl

Time frame:12 weeks

CGM time-in-range

change from baseline, improvement

Posted result

Group	Value (mean), percentage of time	95% CI
Placebo	-1.4	—
Active Drugs	10	—

Secondary/registry result/low confidence

Change in 24-hour Urine Glucose Excretion.

Time frame:12 weeks.

change from baseline, improvement

Posted result

Group	Value (mean), gram/day	95% CI
Placebo	2.1	—
Active Drugs	66.9	—

Secondary/registry result

Change in Total Daily Insulin Requirements

Time frame:12 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Units/Kg	95% CI
Placebo	-0.1	—
Active Drugs	-3.5	—

Secondary/protocol endpoint

Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl

Time frame:12 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Change in 24-hour Urine Glucose Excretion.

Time frame:12 weeks.

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Daily Insulin Requirements

Time frame:12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/registry result

Change in Systolic Blood Pressure Before and After Treatment

Time frame:12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Placebo	-2	—
Active Drugs	-12	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure Before and After Treatment

Time frame:12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Blood Ketone Bodies

Time frame:12 weeks

change from baseline, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/registry result

Change in Blood Ketone Bodies

Time frame:12 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), mM	95% CI
Placebo	-0.03	—
Active Drugs	0.20	—

Publications (1)

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

Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.
The Journal of clinical endocrinology and metabolism2016 Sep (month)PMID27490915doi:10.1210/jc.2016-1451via clinicaltrials gov reference derived + pubmed nct search

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.