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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00620282 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1799
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
49 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Feb 2008
Primary completion
May 2010
Completion
May 2010
First posted
21 Feb 2008 (estimated)
Last update posted
8 Mar 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 3

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

    NCT00620282

    Feb 2008 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug
  • glimepirideDrug

Arms3

  • Experimental

    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 comparator

    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)

  • Active comparator

    Glimepiride

    Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · week 0, week 12

    Registry description

    Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

Secondary outcomes(13)

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

    Time frame · week 0, week 12

    Registry description

    Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

  2. Change in HbA1c (Glycosylated Haemoglobin A1c)

    Time frame · week 0, week 12

    Registry description

    Percentage point change in HbA1c

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame · week 0, week 12

    Registry description

    Change in FPG

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

    Time frame · week 0, week 12

    Registry description

    The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.

  5. Change in Body Weight

    Time frame · week 0, week 12

  6. Fasting Lipid Profile - Change in Total Cholesterol (TC)

    Time frame · week 0, week 12

    Registry description

    Change in TC

  7. Fasting Lipid Profile - Change in LDL-C

    Time frame · week 0, week 12

    Registry description

    Change in LDL-C

  8. Fasting Lipid Profile - Change in HDL-C

    Time frame · week 0, week 12

    Registry description

    Change in HDL-C

  9. Fasting Lipid Profile - Change in Triglycerides (TG)

    Time frame · week 0, week 12

    Registry description

    Change in TG

  10. Biomarkers of Cardiovascular Risk - Change in TNF-alpha

    Time frame · week 0, week 12

    Registry description

    Change in TNF-alpha

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

    Time frame · week 0, week 12

    Registry description

    Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).

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

    Time frame · week 0, week 12

    Registry description

    Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).

  13. Number of Hypoglycaemic Episodes

    Time frame · weeks 0-12

    Registry description

    Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· week 0, week 12

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

GroupValue (mL/100 mL/min)Spread
Lira 1.84.2442.551
Placebo-3.1872.758
Glimepiride2.1642.568
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· week 0, week 12

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

GroupValue (mL/100 mL/min)Spread
Lira 1.83.4552.681
Placebo-1.0442.893
Glimepiride2.7462.67
Secondary outcomeLeast squares mean· week 0, week 12

Change in HbA1c (Glycosylated Haemoglobin A1c)

GroupValue (percentage of total haemoglobin)Spread
Lira 1.8-0.6290.109
Placebo-0.0940.121
Glimepiride-0.5520.112
Secondary outcomeLeast squares mean· week 0, week 12

Change in Fasting Plasma Glucose (FPG)

GroupValue (mg/dL)Spread
Lira 1.8-41.6723.643
Placebo-6.0674.079
Glimepiride-32.0193.708
Secondary outcomeLeast squares mean· week 0, week 12

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

GroupValue (mg/dL)Spread
Lira 1.8-32.1759.104
Placebo-20.30410.619
Glimepiride-35.998.673
Secondary outcomeLeast squares mean· week 0, week 12

Change in Body Weight

GroupValue (kg)Spread
Lira 1.8-1.8210.455
Placebo-0.2930.486
Glimepiride1.0380.441
Secondary outcomeLeast squares mean· week 0, week 12

Fasting Lipid Profile - Change in Total Cholesterol (TC)

GroupValue (mg/dL)Spread
Lira 1.82.0065.274
Placebo4.2435.597
Glimepiride0.0945.239
Secondary outcomeLeast squares mean· week 0, week 12

Fasting Lipid Profile - Change in LDL-C

GroupValue (mg/dL)Spread
Lira 1.81.2434.294
Placebo-2.4594.551
Glimepiride-1.5294.275

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lira 1.8Liraglutide 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)–0 / 1611 / 16
PlaceboPlacebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)–1 / 169 / 16
GlimepirideGlimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12–0 / 175 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

3 results

The effect of liraglutide on endothelial function in patients with type 2 diabetes.

Nandy et al. 2014Diabetes & vascular disease researchcited by 44

PMID 25212693DOI 10.1177/1479164114547358PUB-25212693

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.

Alves et al. 2012Diabetes research and clinical practicecited by 142

PMID 23010561DOI 10.1016/j.diabres.2012.09.008PUB-23010561

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

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.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

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Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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