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Study · Randomized controlled trial · 2023

16 results

The vascular function effects of adding exenatide or meal insulin to basal insulin therapy in early type 2 diabetes.

Retnakaran R, Pu J, Ye C, Emery A, Kramer CK, Zinman B

Cardiovascular diabetology9 Mar 2023Cited by 2 (Europe PMC)

Summary

ObjectiveBasal insulin glargine has a neutral effect on cardiovascular risk in type 2 diabetes (T2DM). In practice, basal insulin is often paired with a glucagon-like peptide-1 receptor agonist (GLP1-RA) or meal insulin; however, the cardiovascular implications of these combinations have not been fully elucidated. In this context, we sought to evaluate the vascular function effects of adding the GLP1-RA exenatide or meal insulin lispro to basal glargine therapy in early T2DM.MethodsIn this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout. At baseline, 8-weeks, and washout, fasting endothelial function was assessed with reactive hyperemia index (RHI) measurement by peripheral arterial tonometry.ResultsAt baseline, there were no differences in blood pressure (BP), heart rate (HR) or RHI between participants randomized to Glar (n = 24), Glar/Lispro (n = 24), and Glar/Exenatide (n = 25). At 8-weeks, Glar/Exenatide decreased systolic BP (mean - 8.1 mmHg [95%CI - 13.9 to - 2.4], p = 0.008) and diastolic BP (mean - 5.1 mmHg [- 9.0 to - 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI. Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR. There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.ConclusionAdding either exenatide or lispro to basal insulin therapy does not appear to affect fasting endothelial function in early T2DM.Trial registrationClinicalTrials.Gov NCT02194595.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study16

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted reactive hyperemia index did not differ between glargine-exenatide and glargine alone.

    In plain wordsIn adults with early type 2 diabetes, adjusted blood vessel function did not differ between glargine-exenatide and glargine alone.

    Outcome
    No significant changeAdjusted reactive hyperemia index versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Vascular function · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Measurements

    Adjusted reactive hyperemia index
    1.81 RHI
    Glar/Exenatide, 8 weeks
    Adjusted reactive hyperemia index
    2.07 RHI
    Glar, 8 weeks

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted blood pressure did not differ between glargine-exenatide and glargine alone.

    In plain wordsIn adults with early type 2 diabetes, adjusted blood pressure did not differ between glargine-exenatide and glargine alone.

    Outcome
    No significant changeAdjusted blood pressure versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted heart rate did not differ between glargine-exenatide and glargine alone.

    In plain wordsIn adults with early type 2 diabetes, adjusted heart rate did not differ between glargine-exenatide and glargine alone.

    Outcome
    No significant changeAdjusted heart rate versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.
  4. 04HumanRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted reactive hyperemia index did not differ between prior glargine-exenatide and glargine.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted blood vessel function did not differ between prior glargine-exenatide and glargine.

    Outcome
    No significant changeReactive hyperemia index after washout versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Vascular function · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.
  5. 05HumanRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted blood pressure did not differ between prior glargine-exenatide and glargine.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted blood pressure did not differ between prior glargine-exenatide and glargine.

    Outcome
    No significant changeBlood pressure after washout versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.
  6. 06HumanRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted heart rate did not differ between prior glargine-exenatide and glargine.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted heart rate did not differ between prior glargine-exenatide and glargine.

    Outcome
    No significant changeHeart rate after washout versus glargine
    Study

    n: not reported in source

    Comparator
    Glargine alone
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    Dose not stated · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

Studies that did not test the peptide alone10

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

  1. 07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, glargine-exenatide reduced systolic blood pressure from baseline.

    In plain wordsIn adults with early type 2 diabetes, glargine-exenatide reduced systolic blood pressure compared with baseline.

    Outcome
    DecreaseSystolic blood pressure from baseline
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Blood pressure · Cardiovascular

    Measurements

    Systolic pressure change
    −8.1 mmHg
    Glargine-exenatide

    Source sentences

    Summary
    At 8-weeks, Glar/Exenatide decreased systolic BP (mean - 8.1 mmHg [95%CI - 13.9 to - 2.4], p = 0.008) and diastolic BP (mean - 5.1 mmHg [- 9.0 to - 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  2. 08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, glargine-exenatide reduced diastolic blood pressure from baseline.

    In plain wordsIn adults with early type 2 diabetes, glargine-exenatide reduced diastolic blood pressure compared with baseline.

    Outcome
    DecreaseDiastolic blood pressure from baseline
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Blood pressure · Cardiovascular

    Measurements

    Diastolic pressure change
    −5.1 mmHg
    Glargine-exenatide

    Source sentences

    Summary
    At 8-weeks, Glar/Exenatide decreased systolic BP (mean - 8.1 mmHg [95%CI - 13.9 to - 2.4], p = 0.008) and diastolic BP (mean - 5.1 mmHg [- 9.0 to - 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  3. 09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, heart rate did not significantly change during glargine-exenatide treatment.

    In plain wordsIn adults with early type 2 diabetes, heart rate did not significantly change with glargine-exenatide compared with baseline.

    Outcome
    No significant changeHeart rate from baseline
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Heart function · Cardiovascular

    Source sentences

    Summary
    At 8-weeks, Glar/Exenatide decreased systolic BP (mean - 8.1 mmHg [95%CI - 13.9 to - 2.4], p = 0.008) and diastolic BP (mean - 5.1 mmHg [- 9.0 to - 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  4. 10HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, reactive hyperemia index did not significantly change during glargine-exenatide treatment.

    In plain wordsIn adults with early type 2 diabetes, the blood vessel function index did not significantly change with glargine-exenatide compared with baseline.

    Outcome
    No significant changeReactive hyperemia index from baseline
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Vascular function · Cardiovascular

    Source sentences

    Summary
    At 8-weeks, Glar/Exenatide decreased systolic BP (mean - 8.1 mmHg [95%CI - 13.9 to - 2.4], p = 0.008) and diastolic BP (mean - 5.1 mmHg [- 9.0 to - 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  5. 11HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted reactive hyperemia index did not differ between glargine-exenatide and glargine-lispro.

    In plain wordsIn adults with early type 2 diabetes, adjusted blood vessel function did not differ between glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeAdjusted reactive hyperemia index versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Vascular function · Cardiovascular

    Measurements

    Adjusted reactive hyperemia index
    1.81 RHI
    Glar/Exenatide, 8 weeks
    Adjusted reactive hyperemia index
    2 RHI
    Glar/Lispro, 8 weeks

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  6. 12HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted blood pressure did not differ between glargine-exenatide and glargine-lispro.

    In plain wordsIn adults with early type 2 diabetes, adjusted blood pressure did not differ between glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeAdjusted blood pressure versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Blood pressure · Cardiovascular

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  7. 13HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with early type 2 diabetes, adjusted heart rate did not differ between glargine-exenatide and glargine-lispro.

    In plain wordsIn adults with early type 2 diabetes, adjusted heart rate did not differ between glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeAdjusted heart rate versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Heart function · Cardiovascular

    Source sentences

    Summary
    Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  8. 14HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted reactive hyperemia index did not differ between prior glargine-exenatide and glargine-lispro.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted blood vessel function did not differ between prior glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeReactive hyperemia index after washout versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Vascular function · Cardiovascular

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  9. 15HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted blood pressure did not differ between prior glargine-exenatide and glargine-lispro.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted blood pressure did not differ between prior glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeBlood pressure after washout versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Blood pressure · Cardiovascular

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  10. 16HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    After washout in adults with early type 2 diabetes, adjusted heart rate did not differ between prior glargine-exenatide and glargine-lispro.

    In plain wordsAfter washout in adults with early type 2 diabetes, adjusted heart rate did not differ between prior glargine-exenatide and glargine-lispro.

    Outcome
    No significant changeHeart rate after washout versus glargine-lispro
    Study

    n: not reported in source

    Comparator
    Glargine-lispro
    Outcome group
    Heart function · Cardiovascular

    Source sentences

    Summary
    There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout.
    1 context sentence
    Summary · context
    In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT02194595

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

Mount Sinai Hospital, Canadan = 105Sept 2014 to Feb 2022

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 11 Apr 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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