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Study · Randomized controlled trial · 2023

13 results

Efficacy and safety of once-weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE-D, AMPLITUDE-L and AMPLITUDE-S randomized controlled trials.

Aroda VR, Frias JP, Ji L, Niemoeller E, Nguyên-Pascal ML, Denkel K, Espinasse M, Guo H, Baek S, Choi J, Lingvay I

Diabetes, obesity & metabolism26 Apr 2023Cited by 12 (Europe PMC)

PMID37013892 (opens in a new tab)DOI10.1111/dom.15079 (opens in a new tab)PepBankPUB-37013892
Source linkPubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In people with type 2 diabetes, efpeglenatide 4 mg was non-inferior to dulaglutide for HbA1c reduction.

    In plain wordsIn people with diabetes, efpeglenatide at this dose was not inferior to dulaglutide for HbA1c reduction.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableHbA1c reduction versus efpeglenatide lower dose
    Study

    n: not reported in source

    Comparator
    Efpeglenatide 4 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg · 56 weeksAs given in this study (human).

    Measurements

    LS mean treatment difference in HbA1c (efpeglenatide 4 mg minus dulaglutide)
    −0.03%
    week 56
    95% CI of HbA1c difference
    −0.2 to 0.14%
    efpeglenatide 4 mg vs dulaglutide, week 56
    LS mean treatment difference in HbA1c (efpeglenatide 4 mg minus dulaglutide)
    −0.35 mmol/mol
    week 56
    95% CI of HbA1c difference
    −2.2 to 1.49 mmol/mol
    efpeglenatide 4 mg vs dulaglutide, week 56

    Source sentences

    Summary
    In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, -0.03% (-0.20%, 0.14%)/-0.35 mmol/mol (-2.20, 1.49); 6 mg, -0.08% (-0.25%, 0.09%)/-0.90 mmol/mol (-2.76, 0.96).
    1 context sentence
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In people with type 2 diabetes, efpeglenatide 6 mg was non-inferior to dulaglutide for HbA1c reduction.

    In plain wordsIn people with diabetes, efpeglenatide at this dose was not inferior to dulaglutide for HbA1c reduction.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableHbA1c reduction versus efpeglenatide higher dose
    Study

    n: not reported in source

    Comparator
    Efpeglenatide 6 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg · 56 weeksAs given in this study (human).

    Measurements

    LS mean treatment difference in HbA1c (efpeglenatide 6 mg minus dulaglutide)
    −0.08%
    week 56
    95% CI of HbA1c difference
    −0.25 to 0.09%
    efpeglenatide 6 mg vs dulaglutide, week 56
    LS mean treatment difference in HbA1c (efpeglenatide 6 mg minus dulaglutide)
    −0.9 mmol/mol
    week 56
    95% CI of HbA1c difference
    −2.76 to 0.96 mmol/mol
    efpeglenatide 6 mg vs dulaglutide, week 56

    Source sentences

    Summary
    In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, -0.03% (-0.20%, 0.14%)/-0.35 mmol/mol (-2.20, 1.49); 6 mg, -0.08% (-0.25%, 0.09%)/-0.90 mmol/mol (-2.76, 0.96).
    1 context sentence
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In AMPLITUDE-D, body weight fell by approximately 3 kg from baseline to week 56, similarly across all treatment groups including dulaglutide 1.5 mg.

    In plain wordsIn people with diabetes, weight reductions were similar across dulaglutide and other trial groups.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeBody weight reduction
    Study

    n: not reported in source

    Comparator
    Other AMPLITUDE-D treatment groups
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.5 mg · 56 weeksAs given in this study (human).

    Measurements

    Body weight reduction from baseline
    ≈ 3 kg
    all AMPLITUDE-D treatment groups, week 56

    Source sentences

    Summary
    The reductions in body weight (approximately 3 kg) from baseline to week 56 were similar across all treatment groups.
    2 context sentences
    Summary · context
    In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, -0.03% (-0.20%, 0.14%)/-0.35 mmol/mol (-2.20, 1.49); 6 mg, -0.08% (-0.25%, 0.09%)/-0.90 mmol/mol (-2.76, 0.96).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
  4. 04HumanRandomized controlled trialSafety outcome

    In AMPLITUDE-D, level 2 hypoglycaemia was reported in no more than 1% of participants across all treatment groups, including the dulaglutide group.

    In plain wordsIn people with diabetes, level 2 low glucose readings occurred in no more than 1% across AMPLITUDE-D groups, including dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableLevel 2 hypoglycaemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    1.5 mgAs given in this study (human).

    Measurements

    Level 2 hypoglycaemia
    ≤ 1%
    AMPLITUDE-D, across all treatment groups

    Source sentences

    Summary
    American Diabetes Association level 2 hypoglycaemia (< 54 mg/dL [< 3.0 mmol/L]) was reported in few participants across all treatment groups (AMPLITUDE-D, ≤ 1%; AMPLITUDE-L, ≤ 10%; and AMPLITUDE-S, ≤ 4%).
    1 context sentence
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In people with T2D, efpeglenatide 4 mg was non-inferior to dulaglutide for HbA1c reduction at week 56.

    In plain wordsIn people with diabetes, efpeglenatide 4 mg was non-inferior to dulaglutide for blood sugar reduction.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableHbA1c reduction
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4 mg once weekly · 56 weeksAs given in this study (human).

    Measurements

    HbA1c treatment difference
    −0.03%
    efpeglenatide 4 mg versus dulaglutide

    Source sentences

    Summary
    In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, -0.03% (-0.20%, 0.14%)/-0.35 mmol/mol (-2.20, 1.49); 6 mg, -0.08% (-0.25%, 0.09%)/-0.90 mmol/mol (-2.76, 0.96).
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In people with T2D, efpeglenatide 6 mg was non-inferior to dulaglutide for HbA1c reduction at week 56.

    In plain wordsIn people with diabetes, efpeglenatide 6 mg was non-inferior to dulaglutide for blood sugar reduction.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableHbA1c reduction
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    6 mg once weekly · 56 weeksAs given in this study (human).

    Measurements

    HbA1c treatment difference
    −0.08%
    efpeglenatide 6 mg versus dulaglutide

    Source sentences

    Summary
    In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, -0.03% (-0.20%, 0.14%)/-0.35 mmol/mol (-2.20, 1.49); 6 mg, -0.08% (-0.25%, 0.09%)/-0.90 mmol/mol (-2.76, 0.96).
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In AMPLITUDE-D participants with T2D, body weight reductions were approximately 3 kg and similar across all groups, including dulaglutide.

    In plain wordsIn people with diabetes, weight reductions were similar across efpeglenatide and dulaglutide groups.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableBody weight reduction in AMPLITUDE-D
    Study

    n: not reported in source

    Comparator
    Dulaglutide
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 56 weeksAs given in this study (human).

    Measurements

    Body weight reduction
    ≈ 3 kg
    all AMPLITUDE-D treatment groups

    Source sentences

    Summary
    The reductions in body weight (approximately 3 kg) from baseline to week 56 were similar across all treatment groups.
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In AMPLITUDE-L and AMPLITUDE-S participants with T2D, all efpeglenatide doses produced numerically greater HbA1c reductions than placebo.

    In plain wordsIn two trials of people with type 2 diabetes, all efpeglenatide doses lowered HbA1c numerically more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseHbA1c reduction in AMPLITUDE-L and AMPLITUDE-S
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In AMPLITUDE-L and AMPLITUDE-S, numerically greater reduction in HbA1c and body weight were observed at all doses of efpeglenatide than placebo.
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In AMPLITUDE-L and AMPLITUDE-S participants with T2D, all efpeglenatide doses produced numerically greater body weight reductions than placebo.

    In plain wordsIn two trials of people with type 2 diabetes, all efpeglenatide doses reduced body weight numerically more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight reduction in AMPLITUDE-L and AMPLITUDE-S
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In AMPLITUDE-L and AMPLITUDE-S, numerically greater reduction in HbA1c and body weight were observed at all doses of efpeglenatide than placebo.
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  10. 10HumanRandomized controlled trialSafety outcome

    In AMPLITUDE-D participants with T2D, level 2 hypoglycaemia affected few participants across all groups, including efpeglenatide, at rates ≤ 1%.

    In plain wordsIn AMPLITUDE-D, low blood sugar affected few people across all groups, including efpeglenatide.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableLevel 2 hypoglycaemia in AMPLITUDE-D
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Level 2 hypoglycaemia
    ≤ 1%
    all AMPLITUDE-D treatment groups

    Source sentences

    Summary
    American Diabetes Association level 2 hypoglycaemia (< 54 mg/dL [< 3.0 mmol/L]) was reported in few participants across all treatment groups (AMPLITUDE-D, ≤ 1%; AMPLITUDE-L, ≤ 10%; and AMPLITUDE-S, ≤ 4%).
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  11. 11HumanRandomized controlled trialSafety outcome

    In AMPLITUDE-L participants with T2D, level 2 hypoglycaemia affected few participants across all groups, including efpeglenatide, at rates ≤ 10%.

    In plain wordsIn AMPLITUDE-L, low blood sugar affected few people across all groups, including efpeglenatide.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableLevel 2 hypoglycaemia in AMPLITUDE-L
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Level 2 hypoglycaemia
    ≤ 10%
    all AMPLITUDE-L treatment groups

    Source sentences

    Summary
    American Diabetes Association level 2 hypoglycaemia (< 54 mg/dL [< 3.0 mmol/L]) was reported in few participants across all treatment groups (AMPLITUDE-D, ≤ 1%; AMPLITUDE-L, ≤ 10%; and AMPLITUDE-S, ≤ 4%).
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  12. 12HumanRandomized controlled trialSafety outcome

    In AMPLITUDE-S participants with T2D, level 2 hypoglycaemia affected few participants across all groups, including efpeglenatide, at rates ≤ 4%.

    In plain wordsIn AMPLITUDE-S, low blood sugar affected few people across all groups, including efpeglenatide.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableLevel 2 hypoglycaemia in AMPLITUDE-S
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Level 2 hypoglycaemia
    ≤ 4%
    all AMPLITUDE-S treatment groups

    Source sentences

    Summary
    American Diabetes Association level 2 hypoglycaemia (< 54 mg/dL [< 3.0 mmol/L]) was reported in few participants across all treatment groups (AMPLITUDE-D, ≤ 1%; AMPLITUDE-L, ≤ 10%; and AMPLITUDE-S, ≤ 4%).
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.
  13. 13HumanRandomized controlled trialSafety outcome

    In people with T2D receiving efpeglenatide, gastrointestinal adverse events were the most frequent adverse events in all three trials.

    In plain wordsIn people with diabetes receiving efpeglenatide, digestive adverse events were the most frequent adverse events across the trials.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The adverse events profile was consistent with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs); gastrointestinal adverse events were most frequent in all three studies.
    3 context sentences
    Summary · context
    To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).
    Summary · context
    Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S).
    Summary · context
    All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.

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

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 3Current

    27 Oct 2026, 16:32 UTC

    Study data updated · source update from Europe PMC

  2. Version 2

    22 Oct 2026, 02:25 UTC

    Study results updated

  3. 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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