← Trials/Trial dossier/NCT01722240

1966

CompletedPhase 3Results posted

Liraglutide in Type 1 Diabetes

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 criteria

•BMI 20-40•HbA1c ≤8.5%

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 IDNCT01722240

Org study ID1966

Secondary ID1R01DK092653-01A1

Timeline

Milestones

Study start2012-11-01actual

Study first posted2012-11-06estimated

Primary completion2019-01-01actual

Study completion2019-07-29actual

Last update posted2024-01-23actual

Results first posted2024-01-23actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day.

2. Regularly measuring blood sugars four times daily.

3. HbA1c of less than 8.5%.

4. Well versed with carbohydrate counting.

5. Age 18-75 years.

6. BMI 20-40 kg/m2

Exclusion criteria

1. Type 1 diabetes for less than 6 months;

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

3. Hepatic disease (transaminase > 3 times normal) or cirrhosis;

4. Renal impairment (serum eGFR < 30ml/min/1.73m2);

5. HIV or Hepatitis B or C positive status;

6. Participation in any other concurrent clinical trial;

7. Any other life-threatening, non-cardiac disease;

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

9. history of pancreatitis

10. pregnancy

11. inability to give informed consent

12. history of gastroparesis

13. history of medullary thyroid carcinoma or MEN 2 syndrome.

Endpoints (6)

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

Weight & body composition

2 endpoints

Secondary/registry result

Body Weight

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Liraglutideweek 0	83.6	—
week 52	80.5	—
Placeboweek 0	84.1	—
week 52	83.8	—

Secondary/protocol endpoint

Body Weight

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/registry result

HbA1c (%)

Time frame:52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent of Hemoglobin (%)	95% CI
Liraglutideweek 0	7.92	—
week 52	7.45	—
Placeboweek 0	7.48	—
week 52	7.58	—

Primary/protocol endpoint

HbA1c (%)

Time frame:52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result/low confidence

Mean Weekly Glucose Concentrations.

Time frame:52 Weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutideweek 0	173	—
week 52	156	—
Placeboweek 0	160	—
week 52	156	—

Secondary/protocol endpoint

Mean Weekly Glucose Concentrations.

Time frame:52 Weeks

change from baseline, improvement

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.