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Study · Randomized controlled trial · 2020

5 results

Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study.

Del Prato S, Kang J, Trautmann ME, Stewart J, Sorli CH, Derwahl M, Soto A, Yoon KH

Diabetes, obesity & metabolism6 Apr 2020Cited by 32 (Europe PMC)

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: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, efpeglenatide reduced HbA1c more than placebo over 16 weeks, with an overall least squares mean difference of -7.7 mmol/mol (-0.71%) from baseline to week 17 (all doses P<0.0001).

    In plain wordsIn patients with diabetes on metformin, efpeglenatide reduced HbA1c more than placebo.

    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    8, 12 or 16 mg once monthly after titration · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Least squares mean difference in HbA1c reduction, efpeglenatide overall vs placebo
    −7.7 mmol/mol
    baseline to week 17
    Least squares mean difference in HbA1c reduction, efpeglenatide overall vs placebo
    −0.71%
    baseline to week 17

    Source sentences

    Summary
    Overall, the least squares mean difference in HbA1c reductions between efpeglenatide and placebo was -7.7 mmol/mol (-0.71%; baseline to week 17).
    3 context sentences
    Summary · context
    All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all).
    Summary · context
    In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51).
    Summary · context
    The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, more efpeglenatide recipients reached HbA1c below 7% than placebo recipients at week 17 (48.7% versus 30.6%; P=0.0320).

    In plain wordsIn patients with diabetes, more efpeglenatide recipients reached HbA1c below 7% than placebo recipients.

    Outcome
    IncreaseHbA1c below 7%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    8, 12 or 16 mg once monthly after titration · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Proportion with HbA1c <53 mmol/mol (<7%)
    48.7%
    efpeglenatide patients, week 17
    Proportion with HbA1c <53 mmol/mol (<7%)
    30.6%
    placebo, week 17

    Source sentences

    Summary
    At week 17, a significantly greater proportion of efpeglenatide patients had an HbA1c level <53 mmol/mol (<7%) versus placebo (48.7% vs. 30.6%; P = 0.0320).
    2 context sentences
    Summary · context
    In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51).
    Summary · context
    The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, all efpeglenatide doses reduced body weight versus placebo, with an overall placebo-corrected reduction of 2.0 kg (P=0.0003).

    In plain wordsIn patients with diabetes, efpeglenatide reduced weight more than placebo.

    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    8, 12 or 16 mg once monthly after titration · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Placebo-corrected body weight change, efpeglenatide overall
    −2 kg
    placebo-corrected

    Source sentences

    Summary
    Significant body weight loss occurred across all efpeglenatide doses (placebo-corrected reduction -2.0 kg [efpeglenatide overall]; P = 0.0003).
    2 context sentences
    Summary · context
    In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51).
    Summary · context
    The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose.
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with diabetes, gastrointestinal disorders were the most common treatment-emergent adverse events with efpeglenatide.

    In plain wordsIn patients with diabetes, digestive disorders were the most common adverse events during efpeglenatide treatment.

    Outcome
    Direction not reportedGastrointestinal disorders
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    8, 12 or 16 mg once monthly after titration · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    The safety profile was consistent with GLP-1RAs, with gastrointestinal (GI) disorders being the most common treatment-emergent adverse events.
    2 context sentences
    Summary · context
    In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51).
    Summary · context
    The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, fluctuations in effects on glucose levels and in rates of gastrointestinal events occurred between peak and trough efpeglenatide concentrations.

    In plain wordsIn patients with diabetes, glucose effects and digestive side effects of efpeglenatide varied between peak and trough drug concentrations.

    Outcome
    MixedGlucose effects and GI event rates across the peak-trough concentration cycle
    Study

    n: not reported in source

    Comparator
    Peak versus trough efpeglenatide concentrations
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    8, 12 or 16 mg once monthly after titration · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Fluctuations in effects on glucose levels and rates of GI events occurred between peak and trough efpeglenatide concentrations.
    2 context sentences
    Summary · context
    In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51).
    Summary · context
    The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose.

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 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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