GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01722266

CompletedPhase 3Results posted

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

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

•HbA1c ≤8.5%•Female

Primary endpoints

•Fasting glucose, change•Mean Weekly Glucose Concentrations

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 IDNCT01722266

Org study IDNN1962

Timeline

Milestones

Study start2012-11-01actual

Study first posted2012-11-06estimated

Primary completion2014-04-01actual

Study completion2014-12-01actual

Results first posted2015-03-13estimated

Last update posted2024-01-05actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

1. 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.

2. Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily

3. HbA1c of less than 8.5%.

4. Well versed with carbohydrate counting

5. Age 18-75 years

Exclusion criteria

1. Type 1 diabetes for less than 12 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 creatinine > 1.5);

5. HIV or Hepatitis 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.

14. Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer

15. Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant

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

Weight & body composition

Other (unclassified)

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight From Baseline

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Placebo	-0.3	—
Liraglutide 1.8mg	-4.8	—
Liraglutide 1.2mg	-5.0	—
Liraglutide 0.6 mg	-2.7	—

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

9 endpoints

Primary/registry result

Change in Mean Weekly Glucose Concentrations

Time frame:12 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dl	95% CI
Placebo	1	—
Liraglutide 1.8mg	-10	—
Liraglutide 1.2mg	-10	—
Liraglutide 0.6 mg	-0.3	—

Primary/protocol endpoint

Change in Mean Weekly Glucose Concentrations

Time frame:12 Weeks

change from baseline, improvement

Secondary/registry result

Change in HbA1c

Time frame:12 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent of Hemoglobin (%)	95% CI
Placebo	-0.30	—
Liraglutide 1.8mg	-0.42	—
Liraglutide 1.2mg	-0.78	—
Liraglutide 0.6 mg	-0.26	—

Secondary/registry result

Change in Total Insulin Dose From Baseline

Time frame:12 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Units of insulin	95% CI
Placebo	-3.4	—
Liraglutide 1.8mg	-10	—
Liraglutide 1.2mg	-12.1	—
Liraglutide 0.6 mg	-2.8	—

Secondary/registry result

Change in the Area Under Curve (AUC) of Glucose Following the Meal

Time frame:12 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), g * 5 h * dL^-1	95% CI
Placebo	0.04	—
Liraglutide 1.8mg	-0.55	—
Liraglutide 1.2mg	-0.55	—
Liraglutide 0.6 mg	-0.01	—

Secondary/registry result

Change in Glucagon Concentrations

Time frame:12 weeks

glucagon concentration change

change from baseline, improvement

Posted result

Group	Value (mean), ng/L	95% CI
Placebo	5	—
Liraglutide 1.8mg	9	—
Liraglutide 1.2mg	-6	—
Liraglutide 0.6 mg	7	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:12 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change in Total Insulin Dose From Baseline

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in the Area Under Curve (AUC) of Glucose Following the Meal

Time frame:12 weeks

Postprandial glucose

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/registry result

Change in Carbohydrate Intake

Time frame:12 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), grams	95% CI
Placebo	-13.4	—
Liraglutide 1.8mg	-46.4	—
Liraglutide 1.2mg	-47.6	—
Liraglutide 0.6 mg	-23.7	—

Other (unclassified)

2 endpoints

Secondary/protocol endpoint

Change in Carbohydrate Intake

Time frame:12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Glucagon Concentrations

Time frame:12 weeks

change from baseline, improvement

Publications (13)

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

Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks.
Diabetes care2016 Jun (month)PMID27208343doi:10.2337/dc15-1136via clinicaltrials gov reference derived + pubmed nct search
Liraglutide as additional treatment to insulin in obese patients with type 1 diabetes mellitus.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2013 Nov-Dec (year)PMID23807520doi:10.4158/EP13065.ORvia CT.gov background
Clinical use of liraglutide in type 2 diabetes and its effects on cardiovascular risk factors.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2012 Mar-Apr (year)PMID21856595doi:10.4158/EP11169.ORvia CT.gov background
Liraglutide as additional treatment for type 1 diabetes.
European journal of endocrinology2011 Jul (month)PMID21646283doi:10.1530/EJE-11-0330via CT.gov background
Durability of effects of exenatide treatment on glycemic control, body weight, systolic blood pressure, C-reactive protein, and triglyceride concentrations.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2011 Mar-Apr (year)PMID20841306doi:10.4158/EP10199.ORvia CT.gov background
Adjunct therapy for type 1 diabetes mellitus.
Nature reviews. Endocrinology2010 Jun (month)PMID20404854doi:10.1038/nrendo.2010.49via CT.gov background
Effect of glucagon-like peptide-1 on alpha- and beta-cell function in C-peptide-negative type 1 diabetic patients.
The Journal of clinical endocrinology and metabolism2010 May (month)PMID20207828doi:10.1210/jc.2009-2440via CT.gov background
Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes.
American journal of hypertension2010 Mar (month)PMID20019672doi:10.1038/ajh.2009.245via CT.gov background
Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes.
Diabetes care2009 Dec (month)PMID19808924doi:10.2337/dc09-0773via CT.gov background
A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus.
Clinical therapeutics2009 Nov (month)PMID20109994doi:10.1016/j.clinthera.2009.11.034via CT.gov background
Glycemia and cardiovascular disease in type 1 diabetes mellitus.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2008 Oct (month)PMID18996824doi:10.4158/EP.14.7.912via CT.gov background
Role of inflammatory mediators in the suppression of insulin receptor phosphorylation in circulating mononuclear cells of obese subjects.
Diabetologia2007 Feb (month)PMID17180352doi:10.1007/s00125-006-0508-9via CT.gov background
Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Clinical therapeutics2007 Jan (month)PMID17379054doi:10.1016/j.clinthera.2007.01.015via CT.gov background

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.