CompletedPhase 3Results posted

The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A 12-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial With an Open-label Glimepiride Arm

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40•HbA1c 6.5-9%

Primary endpoint

•Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00620282

Org study IDNN2211-1799

Timeline

Milestones

Study first posted2008-02-21estimated

Results first posted2011-06-15estimated

Last update posted2017-03-08actual

Study start2008-02 (month precision)

Primary completion2010-05actual (month precision)

Study completion2010-05actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age40 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Diet and lifestyle changes or metformin monotherapy for at least three months

•HbA1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)

•Body Mass Index (BMI) less than or equal to 40 kg/m^2

Exclusion criteria

•Previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)

•Previous treatment with glucagon-like peptide-1 (GLP-1) analogues/mimetics, including treatment in a clinical trial

•Treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening

•Current smoker or history of smoking within 6 months prior to screening

•Evidence of overt cardiovascular disease (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease)

•Abnormal, clinically significant exercise stress electrocardiogram (ECG) test, as judged by the Investigator

•Known retinopathy or maculopathy requiring acute treatment, as judged by the Investigator

•Known autonomic neuropathy, as judged by the Investigator

•Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening

•Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg

Endpoints (28)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:week 0, week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
Lira 1.8	-1.821	-
Placebo	-0.293	-
Glimepiride	1.038	-

Least squares mean-1.52895% CI-2.873 - -0.184p0.0268ANCOVA

Least squares mean-2.85995% CI-4.139 - -1.579ANCOVA

Least squares mean1.33195% CI0.0090 - 2.653p0.0486ANCOVA

Secondary/protocol endpoint

Change in Body Weight

Time frame:week 0, week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change in HbA1c (Glycosylated Haemoglobin A1c)

Time frame:week 0, week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · percentage of total haemoglobin	95% CI
Lira 1.8	-0.629	-
Placebo	-0.094	-
Glimepiride	-0.552	-

Least squares mean-0.53695% CI-0.868 - -0.203p0.0023ANCOVA

Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Least squares mean-0.07795% CI-0.391 - 0.236p0.6207ANCOVA

Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Least squares mean-0.45895% CI-0.8 - -0.116p0.0098ANCOVA

Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	-41.672	-
Placebo	-6.067	-
Glimepiride	-32.019	-

Least squares mean-35.60595% CI-46.797 - -24.413ANCOVA

Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.

Least squares mean-9.65395% CI-20.041 - 0.736p0.0677ANCOVA

Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.

Least squares mean-25.95295% CI-37.429 - -14.475ANCOVA

Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.

Secondary/registry result

Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

Time frame:week 0, week 12

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	-32.175	-
Placebo	-20.304	-
Glimepiride	-35.99	-

Least squares mean-11.87195% CI-40.943 - 17.201p0.4121ANCOVA

Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.

Least squares mean3.81595% CI-21.618 - 29.247p0.7622ANCOVA

Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.

Least squares mean-15.68695% CI-43.838 - 12.466p0.2651ANCOVA

Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.

Secondary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin A1c)

Time frame:week 0, week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

Time frame:week 0, week 12

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Primary/registry result

Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Time frame:week 0, week 12

change from baseline, improvement

Posted result

Group	Least-squares mean · mL/100 mL/min	95% CI
Lira 1.8	4.244	-
Placebo	-3.187	-
Glimepiride	2.164	-

Least squares mean7.4395% CI-0.164 - 15.025p0.0549ANCOVA

Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Least squares mean2.0895% CI-5.215 - 9.375p0.5681ANCOVA

Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Least squares mean5.3595% CI-2.323 - 13.024p0.1668ANCOVA

Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Secondary/registry result/low confidence

Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

Time frame:week 0, week 12

change from baseline, improvement

Posted result

Group	Least-squares mean · mL/100 mL/min	95% CI
Lira 1.8	3.455	-
Placebo	-1.044	-
Glimepiride	2.746	-

Least squares mean4.49995% CI-3.535 - 12.534p0.2648ANCOVA

Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Least squares mean0.70995% CI-6.904 - 8.322p0.8518ANCOVA

Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Least squares mean3.7995% CI-4.194 - 11.774p0.3435ANCOVA

Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.

Secondary/registry result

Fasting Lipid Profile - Change in Total Cholesterol (TC)

Time frame:week 0, week 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	2.006	-
Placebo	4.243	-
Glimepiride	0.094	-

Least squares mean-2.23795% CI-17.829 - 13.354p0.7736ANCOVA

Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.

Least squares mean1.91295% CI-13.168 - 16.991p0.7993ANCOVA

Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.

Least squares mean-4.14995% CI-19.582 - 11.284p0.5903ANCOVA

Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.

Secondary/registry result

Fasting Lipid Profile - Change in LDL-C

Time frame:week 0, week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	1.243	-
Placebo	-2.459	-
Glimepiride	-1.529	-

Least squares mean3.70295% CI-8.96 - 16.365p0.5583ANCOVA

Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.

Least squares mean2.77395% CI-9.537 - 15.082p0.6517ANCOVA

Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.

Least squares mean0.92995% CI-11.646 - 13.505p0.8822ANCOVA

Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.

Secondary/registry result

Fasting Lipid Profile - Change in HDL-C

Time frame:week 0, week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	0.393	-
Placebo	0.562	-
Glimepiride	1.116	-

Least squares mean-0.16995% CI-3.273 - 2.935p0.9131ANCOVA

Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.

Least squares mean-0.72395% CI-3.785 - 2.339p0.6362ANCOVA

Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.

Least squares mean0.55495% CI-2.643 - 3.751p0.7283ANCOVA

Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.

Secondary/registry result

Fasting Lipid Profile - Change in Triglycerides (TG)

Time frame:week 0, week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Least-squares mean · mg/dL	95% CI
Lira 1.8	-8.163	-
Placebo	28.546	-
Glimepiride	-4.377	-

Least squares mean-36.70995% CI-76.467 - 3.048p0.0694ANCOVA

Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.

Least squares mean-3.78695% CI-42.373 - 34.801p0.844ANCOVA

Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.

Least squares mean-32.92395% CI-72.353 - 6.507p0.0994ANCOVA

Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.

Secondary/registry result/low confidence

Biomarkers of Cardiovascular Risk - Change in TNF-alpha

Time frame:week 0, week 12

change from baseline, improvement

Posted result

Group	Least-squares mean · pg/mL	95% CI
Lira 1.8	-0.024	-
Placebo	0.397	-
Glimepiride	-0.0050	-

Least squares mean-0.4295% CI-1.118 - 0.278p0.2282ANCOVA

Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.

Least squares mean-0.01895% CI-0.697 - 0.661p0.9569ANCOVA

Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.

Least squares mean-0.40295% CI-1.097 - 0.293p0.2465ANCOVA

Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.

Secondary/protocol endpoint

Fasting Lipid Profile - Change in Total Cholesterol (TC)

Time frame:week 0, week 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Fasting Lipid Profile - Change in LDL-C

Time frame:week 0, week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Fasting Lipid Profile - Change in HDL-C

Time frame:week 0, week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Fasting Lipid Profile - Change in Triglycerides (TG)

Time frame:week 0, week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Biomarkers of Cardiovascular Risk - Change in TNF-alpha

Time frame:week 0, week 12

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

Time frame:week 0, week 12

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Lira 1.8Week 0	1	-
Week 12	1	-
PlaceboWeek 0	0	-
Week 12	2	-
GlimepirideWeek 0	1	-
Week 12	0	-

Secondary/registry result

Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

Time frame:week 0, week 12

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Lira 1.8Week 0	1	-
Week 12	1	-
PlaceboWeek 0	3	-
Week 12	2	-
GlimepirideWeek 0	5	-
Week 12	2	-

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:weeks 0-12

Documented hypoglycemia

event count, event

Posted result

Group	Number · episodes	95% CI
Lira 1.8Major	0	-
Minor	1	-
Symptoms Only	3	-
PlaceboMajor	0	-
Minor	0	-
Symptoms Only	0	-
GlimepirideMajor	0	-
Minor	10	-
Symptoms Only	4	-

Secondary/protocol endpoint

Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

Time frame:week 0, week 12

threshold achievement, event

Secondary/protocol endpoint

Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

Time frame:week 0, week 12

threshold achievement, event

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:weeks 0-12

Documented hypoglycemia

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Time frame:week 0, week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

Time frame:week 0, week 12

change from baseline, improvement

Publications (3)

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

Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.
Diabetes care2015 Jun (month)PMID25504028doi:10.2337/dc13-1210via CT.gov reference
The effect of liraglutide on endothelial function in patients with type 2 diabetes.
Diabetes & vascular disease research2014 Nov (month)PMID25212693doi:10.1177/1479164114547358via CT.gov reference + pubmed nct search
A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Diabetes research and clinical practice2012 Nov (month)PMID23010561doi:10.1016/j.diabres.2012.09.008via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.