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Study · Randomized controlled trial · n = 240 · 2020

10 results

Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial.

Yang J, Xiao W, Guo L, Li Q, Zhong L, Yang J, Yang J, Gao Y, Tian Q, Hong T

Acta diabetologica23 Mar 2020Cited by 7 (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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, HbA1c decreased significantly from baseline with generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, both generic and branded exenatide reduced HbA1c from baseline.

    Outcome
    DecreaseHbA1c change from baseline
    Study

    n = 240

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −1.1%
    generic exenatide group, 16 weeks, SD 1.31
    HbA1c change from baseline
    −1.08%
    branded exenatide group, 16 weeks, SD 1.11
    HbA1c change from baseline
    −12 mmol/mol
    generic exenatide group, 16 weeks, SD 14.3
    HbA1c change from baseline
    −11.8 mmol/mol
    branded exenatide group, 16 weeks, SD 12.1

    Source sentences

    Summary
    After 16 weeks of treatment, HbA1c levels decreased significantly from baseline in the two groups, with a reduction of - 1.10% ± 1.31% (- 12.0 mmol/mol ± 14.3 mmol/mol) in the generic exenatide group and - 1.08% ± 1.11% (- 11.8 mmol/mol ± 12.1 mmol/mol) in the branded exenatide group (both P < 0.001).
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, generic exenatide met the HbA1c non-inferiority criterion versus branded exenatide.

    In plain wordsIn Chinese patients with diabetes, generic exenatide met the study's HbA1c non-inferiority criterion compared with branded exenatide.

    Outcome
    Not applicableHbA1c non-inferiority
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Measurements

    HbA1c reduction least-squares mean difference
    −0.03%
    generic versus branded exenatide, 16 weeks
    HbA1c reduction least-squares mean difference
    −0.33 mmol/mol
    generic versus branded exenatide, 16 weeks
    Lower one-sided 95% CI limit
    −0.27%
    generic versus branded exenatide, 16 weeks
    Lower one-sided 95% CI limit
    −2.95 mmol/mol
    generic versus branded exenatide, 16 weeks

    Source sentences

    Summary
    The least-squares mean difference of HbA1c reduction between the two groups was - 0.03% (- 0.33 mmol/mol), with a lower one-sided 95% CI limit of - 0.27% (- 2.95 mmol/mol), which was higher than the prespecified non-inferiority margin of - 0.35% (- 3.83 mmol/mol).
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, HbA1c target attainment did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, HbA1c target attainment was similar with generic and branded exenatide.

    Outcome
    No significant changeHbA1c below 7%
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, fasting glucose changes did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, fasting glucose changes were similar with generic and branded exenatide.

    Outcome
    No significant changeFasting plasma glucose
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, postprandial glucose changes did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, postmeal glucose changes were similar with generic and branded exenatide.

    Outcome
    No significant change2-hour postprandial glucose
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, SMBG profile changes did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, monitored glucose profile changes were similar with generic and branded exenatide.

    Outcome
    No significant change7-point SMBG profiles
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, weight changes did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, weight changes were similar with generic and branded exenatide.

    Outcome
    No significant changeBody weight
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with type 2 diabetes, week 8 HbA1c changes did not differ significantly between generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, week 8 HbA1c changes were similar with generic and branded exenatide.

    Outcome
    No significant changeHbA1c at week 8
    Study

    n = 240

    Comparator
    Branded exenatide
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Moreover, there were no significant differences in the proportion of participants achieving HbA1c  0.05) between the two groups.
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  9. 09HumanRandomized controlled trialSafety outcome

    In Chinese patients with type 2 diabetes, adverse event incidence was similar with generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, adverse event rates were similar with generic and branded exenatide.

    Outcome
    No significant changeAdverse events
    Study

    n = 240

    Comparator
    Branded exenatide
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.
  10. 10HumanRandomized controlled trialSafety outcome

    In Chinese patients with type 2 diabetes, hypoglycemia incidence was similar with generic and branded exenatide.

    In plain wordsIn Chinese patients with diabetes, low blood sugar rates were similar with generic and branded exenatide.

    Outcome
    No significant changeHypoglycemia
    Study

    n = 240

    Comparator
    Branded exenatide
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 16 weeksAs given in this study (human).

    Measurements

    Hypoglycemia incidence
    18.3%
    generic exenatide
    Hypoglycemia incidence
    17.5%
    branded exenatide

    Source sentences

    Summary
    The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
    1 context sentence
    Summary · context
    A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment.

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

    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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