Phase 3
Completed N=49
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00620282 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Jun 2011
Primary outcomePrimary: Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) — 4.244; -3.187; 2.164 mL/100 mL/min — p=0.0549
Summary
This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) |
4.244; -3.187; 2.164 | 0.0549 |
| SECONDARY Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF) |
3.455; -1.044; 2.746 | 0.2648 |
| SECONDARY Change in HbA1c (Glycosylated Haemoglobin A1c) |
-0.629; -0.094; -0.552 | 0.0023 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-41.672; -6.067; -32.019 | 0.0677 |
| SECONDARY Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles |
-32.175; -20.304; -35.99 | 0.4121 |
| SECONDARY Change in Body Weight |
-1.821; -0.293; 1.038 | 0.0268 sig |
| SECONDARY Fasting Lipid Profile - Change in Total Cholesterol (TC) |
2.006; 4.243; 0.094 | 0.7736 |
| SECONDARY Fasting Lipid Profile - Change in LDL-C |
1.243; -2.459; -1.529 | 0.5583 |
| SECONDARY Fasting Lipid Profile - Change in HDL-C |
0.393; 0.562; 1.116 | 0.9131 |
| SECONDARY Fasting Lipid Profile - Change in Triglycerides (TG) |
-8.163; 28.546; -4.377 | 0.0694 |
| SECONDARY Biomarkers of Cardiovascular Risk - Change in TNF-alpha |
-0.024; 0.397; -0.0050 | 0.2282 |
| SECONDARY Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range |
1; 0; 1; 1; 2; 0 | — |
| SECONDARY Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range |
1; 3; 5; 1; 2; 2 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
0; 0; 0; 1; 0; 10 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00620282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.