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Study · Randomized controlled trial · n = 25 · 2019

19 results

The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus.

Wang J, Li HQ, Xu XH, Kong XC, Sun R, Jing T, Ye L, Su XF, Ma JH

BioMed research international24 Dec 2019Cited by 21 (Europe PMC)

Summary

Aim. To compare the effects of once-weekly Dulaglutide with once-daily glargine in poorly oral-antidiabetic controlled patients with type 2 diabetes mellitus (T2DM). Method. A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9). All patients received either Dulaglutide or glargine treatments for 52 weeks. Continuous glucose monitoring systems (CGMS) were applied to them for two 72 h periods at before and after the treatment each. Patient general clinical data were collected and analyzed. Result. Fast blood glucose (FBG) of the glargine group declined more significantly than the Dulaglutide group after treatment (p < 0.05). The mean blood glucose (MBG), standard deviation of blood glucose (SDBG), mean amplitude of glycemic excursion (MAGE) within a day, the largest amplitude of glycemic excursion (LAGE), M-value, absolute means of daily difference (MODD) of glycemic excursion, the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05). The incidence of hypoglycemia was also similar between the two groups (p > 0.05). Though serum levels of TNF-α, IL-6, and 8-PGF2α all decreased, significant reduction was found in TNF-α and 8-PGF2α. TNF-α was only significantly reduced in the Dulaglutide group, while 8-PGF2α was seen in both groups. Conclusion. For T2DM patients with poorly controlled oral antidiabetic drugs, once-weekly Dulaglutide not only has the same effect on glucose fluctuation as once-daily glargine but also significantly reduced TNF-α and 8-PGF2α after a 52 week treatment protocol. This trial is registered with ClinicalTrials.gov NCT01648582.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study19

17 results from studies that gave the peptide. 17 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, fasting blood glucose declined less with dulaglutide than glargine.

    In plain wordsIn patients with T2DM, fasting blood sugar fell less with dulaglutide than glargine.

    Outcome
    IncreaseFasting blood glucose
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Fast blood glucose (FBG) of the glargine group declined more significantly than the Dulaglutide group after treatment (p < 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, mean blood glucose was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, average blood sugar was similar with dulaglutide and glargine.

    Outcome
    No significant changeMean blood glucose
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The mean blood glucose (MBG),
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, blood glucose standard deviation was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, blood sugar variation was similar with dulaglutide and glargine.

    Outcome
    No significant changeStandard deviation of blood glucose
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    standard deviation of blood glucose (SDBG),
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, MAGE was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, average blood sugar swings were similar with dulaglutide and glargine.

    Outcome
    No significant changeMean amplitude of glycemic excursion
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    mean amplitude of glycemic excursion (MAGE) within a day,
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, LAGE was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, the largest blood sugar swings were similar with dulaglutide and glargine.

    Outcome
    No significant changeLargest amplitude of glycemic excursion
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the largest amplitude of glycemic excursion (LAGE),
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, M-value was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, M-value was similar with dulaglutide and glargine.

    Outcome
    No significant changeM-value
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    M-value, absolute means of daily difference (MODD) of glycemic excursion,
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, MODD was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, daily blood sugar differences were similar with dulaglutide and glargine.

    Outcome
    No significant changeAbsolute means of daily difference
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    absolute means of daily difference (MODD) of glycemic excursion,
    3 context sentences
    Summary · context
    were similar between the two groups (p > 0.05).
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose ≤2.8 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose ≤2.8 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose ≤2.8 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose ≤3.9 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose ≤3.9 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose ≤3.9 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose ≥10.0 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose ≥10.0 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose ≥10.0 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose ≥13.9 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose ≥13.9 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose ≥13.9 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose 3.9-7.8 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose 3.9-7.8 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose 3.9-7.8 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, time at glucose 9-10.0 mmol/L was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, time at glucose 9-10.0 mmol/L was similar with dulaglutide and glargine.

    Outcome
    No significant changeTime at glucose 9-10.0 mmol/L
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  14. 14HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, maximum glucose was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, maximum blood sugar was similar with dulaglutide and glargine.

    Outcome
    No significant changeMaximum glycemic value
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  15. 15HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, minimum glucose was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, minimum blood sugar was similar with dulaglutide and glargine.

    Outcome
    No significant changeMinimum glycemic value
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    and minimum glycemic value were similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  16. 16HumanRandomized controlled trialSafety outcome

    In patients with T2DM, hypoglycemia incidence was similar with dulaglutide and glargine.

    In plain wordsIn patients with T2DM, low blood sugar occurred at similar rates with dulaglutide and glargine.

    Outcome
    No significant changeHypoglycemia incidence
    Study

    n = 25

    Comparator
    Insulin glargine
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The incidence of hypoglycemia was also similar between the two groups (p > 0.05).
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.
  17. 17HumanRandomized controlled trialEfficacy outcome

    In patients with T2DM, TNF-alpha decreased significantly only in the dulaglutide group.

    In plain wordsIn patients with T2DM, TNF-alpha fell significantly from baseline only in the dulaglutide group.

    Outcome
    DecreaseTNF-alpha
    Study

    n = 16

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    TNF-α was only significantly reduced in the Dulaglutide group, while 8-PGF2α was seen in both groups.
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.

Studies that did not test the peptide alone2

In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).

  1. 18HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome

    In patients with T2DM, 8-PGF2alpha decreased significantly in both dulaglutide and glargine groups.

    In plain wordsIn patients with T2DM, 8-PGF2α fell significantly in both the dulaglutide and glargine groups.

    Outcome
    Decrease8-PGF2alpha
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Immune and inflammation

    Source sentences

    Summary
    TNF-α was only significantly reduced in the Dulaglutide group, while 8-PGF2α was seen in both groups.
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.

    In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).

  2. 19HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome

    In patients with T2DM, serum IL-6 decreased, but the abstract reports significant reductions only for TNF-alpha and 8-PGF2alpha.

    In plain wordsIn patients with T2DM, IL-6 fell, but the fall was not reported as significant.

    Outcome
    No significant changeIL-6
    Study

    n = 25

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Immune and inflammation

    Source sentences

    Summary
    Though serum levels of TNF-α, IL-6, and 8-PGF2α all decreased, significant reduction was found in TNF-α and 8-PGF2α.
    2 context sentences
    Summary · context
    A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9).
    Summary · context
    All patients received either Dulaglutide or glargine treatments for 52 weeks.

    In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01648582

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

Eli Lilly and Companyn = 774Jul 2012 to Dec 2014

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 18 Sept 2019

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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