Phase 3 · Liraglutide

NCT00620282 trial results

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

Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) (mL/100 mL/min), week 0, week 12. Lira 1.8: 4.244; Placebo: -3.187; Glimepiride: 2.164.

Participants
49
Status
completed
Completed
2010-05
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT00620282), updated at source Mar 8, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00620282 measured first

Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)mL/100 mL/min · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
4.244(2.551)-3.187(2.758)2.164(2.568)
Side effects by arm

Side effects in NCT00620282

Percent of participants affected, The adverse events were collected from week 0 to week 12.. The most common events the registry lists.

EventLira 1.8PlaceboGlimepiride
Any serious event0%6.3%0%
Dyspepsia12.5%0%0%
Nausea12.5%0%0%
Vomiting12.5%0%0%
Abdominal pain upper6.3%0%0%
Diarrhoea6.3%0%0%
Parotid Duct Obstruction6.3%0%0%
Chest Pain0%6.3%0%
Fatigue0%6.3%0%
Oedema peripheral6.3%0%0%
Bronchitis0%6.3%0%
Gastroenteritis viral6.3%0%0%
Otitis media0%6.3%0%
Sinusitis6.3%0%0%
Arthropod Bite6.3%0%0%
Back Injury0%6.3%0%
Fall6.3%0%0%
Head Injury6.3%0%0%
Joint dislocation0%6.3%0%
Procedural Pain0%6.3%0%
Skin laceration6.3%0%0%
Decreased appetite6.3%0%0%
Musculoskeletal pain6.3%0%0%
Pain In Extremity0%6.3%0%
Prostate Cancer0%6.3%0%
Amnesia6.3%0%0%
Secondary outcomes

What else it measured

Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)mL/100 mL/min · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
3.455(2.681)-1.044(2.893)2.746(2.67)
Change in HbA1c (Glycosylated Haemoglobin A1c)percentage of total haemoglobin · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
-0.629(0.109)-0.094(0.121)-0.552(0.112)
Change in Fasting Plasma Glucose (FPG)mg/dL · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
-41.672(3.643)-6.067(4.079)-32.019(3.708)
Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profilesmg/dL · week 0, week 12 · least squares mean
Lira 1.8n=13Placebon=10Glimepiriden=14
-32.175(9.104)-20.304(10.619)-35.99(8.673)
Change in Body Weightkg · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=17
-1.821(0.455)-0.293(0.486)1.038(0.441)
Fasting Lipid Profile - Change in Total Cholesterol (TC)mg/dL · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
2.006(5.274)4.243(5.597)0.094(5.239)
Fasting Lipid Profile - Change in LDL-Cmg/dL · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
1.243(4.294)-2.459(4.551)-1.529(4.275)
Fasting Lipid Profile - Change in HDL-Cmg/dL · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
0.393(1.053)0.562(1.133)1.116(1.074)
Fasting Lipid Profile - Change in Triglycerides (TG)mg/dL · week 0, week 12 · least squares mean
Lira 1.8n=16Placebon=14Glimepiriden=16
-8.163(13.471)28.546(14.282)-4.377(13.399)
Biomarkers of Cardiovascular Risk - Change in TNF-alphapg/mL · week 0, week 12 · least squares mean
Lira 1.8n=12Placebon=10Glimepiriden=12
-0.024(0.232)0.397(0.25)-0.0050(0.231)
Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Rangeparticipants · week 0, week 12 · number
MeasureLira 1.8n=16Placebon=16Glimepiriden=17
Week 0101
Week 12120
Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Rangeparticipants · week 0, week 12 · number
MeasureLira 1.8n=16Placebon=16Glimepiriden=17
Week 0135
Week 12122
The trial

How NCT00620282 was run

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.

  • Lira 1.8: Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
  • Placebo: Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
  • Glimepiride: Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
Who could join the trial

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

Published papers

Papers from NCT00620282

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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