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Study · Randomized controlled trial · n = 181 · 2019

8 results

Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.

Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH

Diabetes care18 Jul 2019Cited by 32 (Europe PMC)

PMID31320446 (opens in a new tab)DOI10.2337/dc18-2648 (opens in a new tab)PepBankPUB-31320446
Publisher pagePubMedAsk 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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In early T2D, efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo, with placebo-adjusted reductions of 0.6-1.2%.

    In plain wordsIn people with early diabetes, efpeglenatide doses ≥1 mg reduced blood sugar more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseHbA1c reduction at week 13
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    ≥1 mg once weekly · 12 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted HbA1c reduction
    0.6 to 1.2%
    efpeglenatide doses ≥1 mg
    Final HbA1c
    6.3 to 6.8%
    efpeglenatide doses ≥1 mg

    Source sentences

    Summary
    From a baseline HbA1c of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%, P 1c of 6.3-6.8% (45.4-50.6 mmol/mol)
    4 context sentences
    Summary · context
    The primary efficacy end point was change in HbA1c from baseline to week 13.
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In early T2D, masked efpeglenatide 4 mg was noninferior to open-label liraglutide for HbA1c reduction.

    In plain wordsIn people with early diabetes, efpeglenatide 4 mg was noninferior to liraglutide for blood sugar reduction.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableHbA1c reduction
    Study

    n: not reported in source

    Comparator
    Open-label liraglutide
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4 mg once weekly · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    masked efpeglenatide 4 mg was noninferior to open-label liraglutide.
    1 context sentence
    Summary · context
    The primary efficacy end point was change in HbA1c from baseline to week 13.
  3. 03HumanRandomized controlled trialSafety outcome

    In early T2D, nausea rates with efpeglenatide were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks.

    In plain wordsIn people with early diabetes, nausea with efpeglenatide rapidly subsided after the initial 2 weeks.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableNausea
    Study

    n = 181

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Rates of nausea and vomiting were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks.
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  4. 04HumanRandomized controlled trialSafety outcome

    In early T2D, vomiting rates with efpeglenatide were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks.

    In plain wordsIn people with early diabetes, vomiting with efpeglenatide rapidly subsided after the initial 2 weeks.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableVomiting
    Study

    n = 181

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Rates of nausea and vomiting were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks.
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  5. 05HumanRandomized controlled trialSafety outcome

    In people with early T2D, no neutralizing antibodies were detected with efpeglenatide.

    In plain wordsIn people with early diabetes, no neutralizing antibodies were detected with efpeglenatide.

    Peptide
    Efpeglenatide
    Outcome
    Not applicableNeutralizing antibodies
    Study

    n = 181

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No neutralizing antibodies were detected with efpeglenatide.
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In early T2D, more participants reached HbA1c <7% with efpeglenatide ≥1 mg than placebo, at 61-72% versus 24%.

    In plain wordsIn people with early diabetes, more participants reached the blood sugar target with efpeglenatide than placebo.

    Peptide
    Efpeglenatide
    Outcome
    IncreaseHbA1c below 7%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    ≥1 mg once weekly · 12 weeksAs given in this study (human).

    Measurements

    HbA1c <7% responders
    61 to 72%
    efpeglenatide ≥1 mg
    HbA1c <7% responders
    24%
    placebo

    Source sentences

    Summary
    Greater proportions treated with efpeglenatide ≥1 mg than placebo achieved HbA1c P < 0.05 for all)
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In early T2D, efpeglenatide 3 mg reduced body weight more than placebo, with a placebo-adjusted difference of -1.4 kg.

    In plain wordsIn people with early diabetes, efpeglenatide 3 mg reduced weight more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3 mg once weekly · 12 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted body weight difference
    −1.4 kg
    efpeglenatide 3 mg

    Source sentences

    Summary
    and greater reductions in body weight were observed with efpeglenatide 3 and 4 mg versus placebo (placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively, P < 0.05 for both).
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In early T2D, efpeglenatide 4 mg reduced body weight more than placebo, with a placebo-adjusted difference of -2.0 kg.

    In plain wordsIn people with early diabetes, efpeglenatide 4 mg reduced weight more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4 mg once weekly · 12 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted body weight difference
    −2 kg
    efpeglenatide 4 mg

    Source sentences

    Summary
    and greater reductions in body weight were observed with efpeglenatide 3 and 4 mg versus placebo (placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively, P < 0.05 for both).
    3 context sentences
    Summary · context
    To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
    Summary · context
    EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis).
    Summary · context
    Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36).

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 2NCT02057172

Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

Hanmi Pharmaceutical Company Limitedn = 254Jan 2014 to Dec 2014

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 9 Aug 2016

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. Versions 4 to 6Current

    28 Oct 2026, 02:03 UTC

    The same notice was added 3 times, first on 27 Oct 2026, 18:20 UTC. The status did not change between them.

    Study results updated

  2. Version 3

    27 Oct 2026, 16:32 UTC

    Study data updated · source update from Europe PMC

  3. Version 2

    12 Oct 2026, 12:10 UTC

    Study results updated

  4. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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