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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

Short name LEADER®

NCTNCT01179048 (opens ClinicalTrials.gov in a new tab)Other idEX2211-3748Other id2009-012201-19Other idU1111-1113-7090Other idCTR20130003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
9,341 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
30 countries

United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan

Start
31 Aug 2010
Primary completion
17 Dec 2015
Completion
17 Dec 2015
First posted
10 Aug 2010 (estimated)
Last update posted
17 Jul 2019
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
2010201120122013201420152016
  1. Ph 3

    LEADER®

    NCT01179048

    31 Aug 2010 to 17 Dec 2015

Registry summary

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

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.

Secondary outcomes(5)

  1. Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.

  2. Time From Randomisation to All Cause Death

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.

  3. Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.

  4. Time From Randomisation to First Occurrence of a Composite Microvascular Outcome

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: * new onset of persistent macroalbuminuria * persistent doubling of serum creatinine * need for continuous renal replacement therapy * death due to renal disease * need for retinal photocoagulation or treatment with intravitreal agents * vitreous haemorrhage * diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.

  5. Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.

    Time frame · from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

    Registry description

    Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.

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 outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

GroupValue (percentage of subjects)
Liraglutide13.0
Placebo14.9
Secondary and other outcome results(5)
Secondary outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.

GroupValue (percentage of subjects)
Liraglutide20.3
Placebo22.7
Secondary outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Randomisation to All Cause Death

GroupValue (percentage of subjects)
Liraglutide8.2
Placebo9.6
Secondary outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

GroupValue (percentage of subjects)
Liraglutide4.7
Placebo6.0
Secondary outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Randomisation to First Occurrence of a Composite Microvascular Outcome

GroupValue (Percentage of subjects)
Liraglutide7.6
Placebo8.9
Secondary outcomeNumber· from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.

GroupValue (Percentage of subjects)
Liraglutide5.7
Placebo7.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideSubjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.–2320 / 4668684 / 4668
PlaceboSubjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.–2354 / 4672210 / 4672

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

Studies40

Studies that cite this trial.

Studies with results

22 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2022

6 results

A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study.

Heller et al. 2022Diabetologiacited by 25

PMID 34704120PMC8660716DOI 10.1007/s00125-021-05556-7PUB-34704120

CC BY6 results
Download PDFSee results (6)

Indexing hint: Randomized controlled trial · 2021

4 results

Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial.

Persson et al. 2021Diabetes carecited by 54

PMID 33504496PMC7985419DOI 10.2337/dc20-1622PUB-33504496

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2020

4 results

Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease.

Mann et al. 2020Clinical journal of the American Society of Nephrology : CJASNcited by 42

PMID 32132141PMC7133133DOI 10.2215/cjn.11881019PUB-32132141

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2020

8 results

Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure.

Marso et al. 2020Journal of the American College of Cardiologycited by 90

PMID 32164886DOI 10.1016/j.jacc.2019.12.063PUB-32164886

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2020

3 results

Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial.

Buse et al. 2020Diabetes carecited by 135

PMID 32366578PMC7305014DOI 10.2337/dc19-2251PUB-32366578

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2020

4 results

The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials.

Leiter et al. 2020Diabetes, obesity & metabolismcited by 29

PMID 32372454PMC7496251DOI 10.1111/dom.14079PUB-32372454

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2020

4 results

Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials.

Verma et al. 2020Diabetes, obesity & metabolismcited by 18

PMID 32643857PMC7689837DOI 10.1111/dom.14140PUB-32643857

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2019

4 results

Health-related quality of life in people with type 2 diabetes participating in the LEADER trial.

Nauck et al. 2019Diabetes, obesity & metabolismcited by 28

PMID 30260088PMC6587748DOI 10.1111/dom.13547PUB-30260088

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2019

6 results

Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial.

Tack et al. 2019Diabetes, obesity & metabolismcited by 10

PMID 31282028PMC6852575DOI 10.1111/dom.13826PUB-31282028

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2019

4 results

Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial.

Nauck et al. 2019Diabetes carecited by 51

PMID 31399438PMC7364668DOI 10.2337/dc19-0415PUB-31399438

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2019

4 results

Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial.

Verma et al. 2019JAMA cardiologycited by 51

PMID 31721979PMC6865601DOI 10.1001/jamacardio.2019.3080PUB-31721979

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2018

3 results

No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial.

Hegedüs et al. 2018Diabetes carecited by 47

PMID 29279300DOI 10.2337/dc17-1956PUB-29279300

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2018

7 results

Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial.

Nauck et al. 2018Diabetes carecited by 77

PMID 29898902PMC6463597DOI 10.2337/dc17-1825PUB-29898902

Rights unknown7 results
Source linkSee results (7)

Indexing hint: Randomized controlled trial · 2018

2 results

Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience.

Zinman et al. 2018Diabetes carecited by 84

PMID 29903847DOI 10.2337/dc17-2677PUB-29903847

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2018

1 result

Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo in the LEADER trial.

Nauck et al. 2018Diabetes & vascular disease researchcited by 23

PMID 29947247PMC6130125DOI 10.1177/1479164118783935PUB-29947247

Free to read · publisher termsCC BY-NC1 result
Read at sourceSee results (1)

Indexing hint: Randomized controlled trial · 2018

5 results

The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial.

Dhatariya et al. 2018Diabetes carecited by 107

PMID 30072400PMC6150424DOI 10.2337/dc18-1094PUB-30072400

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2018

3 results

Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke.

Verma et al. 2018Circulationcited by 95

PMID 30566004DOI 10.1161/circulationaha.118.034516PUB-30566004

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

Indexing hint: Randomized controlled trial · 2018

13 results

Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease.

Mann et al. 2018Circulationcited by 110

PMID 30566006PMC6296845DOI 10.1161/circulationaha.118.036418PUB-30566006

Free to read · publisher termsCC BY-NC-ND13 results
Read at sourceSee results (13)

Indexing hint: Randomized controlled trial · 2017

6 results

Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial.

Steinberg et al. 2017Diabetes carecited by 66

PMID 28476871DOI 10.2337/dc16-2747PUB-28476871

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2017

4 results

Liraglutide and Renal Outcomes in Type 2 Diabetes.

Mann et al. 2017The New England journal of medicinecited by 920

PMID 28854085DOI 10.1056/nejmoa1616011PUB-28854085

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2016

LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

Petrie et al. 2016Journal of hypertensioncited by 12

PMID 26855018PMC4856174DOI 10.1097/hjh.0000000000000890PUB-26855018

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 2016

LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial.

Masmiquel et al. 2016Cardiovascular diabetologycited by 37

PMID 26864124PMC4750199DOI 10.1186/s12933-016-0341-5PUB-26864124

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2015

LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations.

Daniels et al. 2015Diabetes, obesity & metabolismcited by 17

PMID 25656058PMC4405040DOI 10.1111/dom.12444PUB-25656058

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 2014

LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial.

Steinberg et al. 2014Pancreascited by 61

PMID 25275271PMC4206347DOI 10.1097/mpa.0000000000000229PUB-25275271

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2013

Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial.

Marso et al. 2013American heart journalcited by 161

PMID 24176437DOI 10.1016/j.ahj.2013.07.012PUB-24176437

Full text at the publisher
Publisher page

More studies

13 studies on this page

PubMed tag: none · 2022

Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease.

Verma et al. 2022Diabetes, obesity & metabolismcited by 45

PMID 35332654PMC9325529DOI 10.1111/dom.14700PUB-35332654

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2020

Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.

Nauck et al. 2020Diabetes carecited by 2

PMID 31959650PMC7411284DOI 10.2337/dci19-0067PUB-31959650

Rights unknown
Source link

PubMed tag: none · 2020

Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial.

Crowley et al. 2020Diabetes carecited by 37

PMID 32647053PMC7440910DOI 10.2337/dc20-0437PUB-32647053

Rights unknown
Source link

PubMed tag: none · 2020

Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials.

Verma et al. 2020Diabetes, obesity & metabolismcited by 74

PMID 32744418PMC7754406DOI 10.1111/dom.14160PUB-32744418

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2019

Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial.

Gilbert et al. 2019Annals of internal medicinecited by 52

PMID 30508430DOI 10.7326/m18-1569PUB-30508430

Full text at the publisher
Publisher page

PubMed tag: none · 2019

Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials.

Verma et al. 2019Diabetes, obesity & metabolismcited by 24

PMID 30851070PMC6619033DOI 10.1111/dom.13698PUB-30851070

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2019

Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network.

Hinton et al. 2019Diabetes, obesity & metabolismcited by 19

PMID 30900349PMC6619442DOI 10.1111/dom.13710PUB-30900349

CC BY
Download PDF

PubMed tag: none · 2018

Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial).

Marso et al. 2018The American journal of cardiologycited by 16

PMID 29627109DOI 10.1016/j.amjcard.2018.02.030PUB-29627109

Free to read · publisher termsCC BY-NC-ND
Read at source

PubMed tag: none · 2018

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.

Wittbrodt et al. 2018The American journal of managed carecited by 21

PMID 29693361PUB-29693361

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2018

Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial.

Verma et al. 2018Circulationcited by 71

PMID 29760228DOI 10.1161/circulationaha.118.033898PUB-29760228

Full text at the publisher
Publisher page

PubMed tag: none · 2018

Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipoprotein Cholesterol Levels and Statin Use.

Verma et al. 2018Circulationcited by 28

PMID 30354517DOI 10.1161/circulationaha.118.036862PUB-30354517

Full text at the publisher
Publisher page

PubMed tag: none · 2018

Liraglutide and Glycaemic Outcomes in the LEADER Trial.

Zinman et al. 2018Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 38

PMID 30392095PMC6250637DOI 10.1007/s13300-018-0524-zPUB-30392095

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2016

LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ.

Rutten et al. 2016Diabetology & metabolic syndromecited by 9

PMID 27274772PMC4891842DOI 10.1186/s13098-016-0153-5PUB-27274772

CC BY
Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultSatman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Orsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications. 2016 Nov-Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3. PMID 27320184

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion

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