A Randomized Study to Compare the Effects of Once-Weekly Dulaglutide Injection and Once-Daily Glimepiride on Glucose Fluctuation of Type 2 Diabetes Mellitus Patients: A 26-Week Follow-Up.

Li H, Xu X, Wang J, Kong X, Chen M, Jing T, Zhang Z, Yin G, Liu X, Hu Y, Ye L, Su X, Ma J

Journal of diabetes research30 Apr 2019Cited by 17 (Europe PMC)

PMID31183384PMCIDPMC6515022DOI10.1155/2019/6423987PepBankPUB-31183384

Summary

ObjectiveTo evaluate the effects of once-weekly dulaglutide injection and once-daily glimepiride on glucose fluctuation in patients with type 2 diabetes mellitus (T2DM) using the Continuous Glucose Monitoring System (CGMS).MethodsA total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10). 72-hour CGMS was applied to all patients: before and after the treatment. General clinical data were collected and measured, such as fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), tumor necrosis factor-α (TNF-α), 8-iso-prostaglandin F2α (8-iso-PGF2α), and interleukin-6 (IL-6).ResultsHbA1c of the dulaglutide group was reduced from 8.38 ± 0.93% to 6.68 ± 0.73% after the treatment (P P < 0.05) in the glimepiride group. The levels of serum 8-iso-PGF2α, TNF-α, and IL-6 all decreased significantly in both groups after treatment, and there was no significant difference found between the two groups (P > 0.05). The Mean Blood Glucose (MBG) of the two groups declined significantly after therapy (P < 0.05). However, the Standard Deviation of Blood Glucose (SDBG) decreased significantly only in the dulaglutide group (from 2.57 ± 0.74 mmol/L to 1.98 ± 0.74 mmol/L, P < 0.05). There were no significant changes of Mean Amplitude of Glycemic Excursion (MAGE) and Absolute Means of Daily Difference (MODD) after treatment in both groups. Furthermore, no statistically significant difference was found between the two groups in MBG, SDBG, MAGE, and MODD (P > 0.05). The percentage time (PT) (>10 mmol/L and 3.9-10 mmol/L) of the two groups was significantly changed after the treatment (P < 0.05). However, this was not seen in the PT P > 0.05).ConclusionOnce-weekly dulaglutide injection has the same effectiveness as daily glimepiride on lowering blood glucose and decreasing oxidation stress and inflammation and is more effective in controlling glucose fluctuation as compared with glimepiride. This trial is registered with ClinicalTrials.gov NCT01644500.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study15

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

01HumanRandomized controlled trialEfficacy outcome
In T2DM patients, serum 8-iso-PGF2α decreased in both groups without a significant difference between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, this oxidative stress marker fell in both groups without a significant difference between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeSerum 8-iso-PGF2α
Study
n = 23
Comparator
Glimepiride
Outcome group
Oxidative stress · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
The levels of serum 8-iso-PGF2α, TNF-α, and IL-6 all decreased significantly in both groups after treatment, and there was no significant difference found between the two groups (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338402
02HumanRandomized controlled trialEfficacy outcome
In T2DM patients, TNF-α decreased in both groups without a significant difference between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, TNF-α fell in both groups without a significant difference between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeSerum TNF-α
Study
n = 23
Comparator
Glimepiride
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
The levels of serum 8-iso-PGF2α, TNF-α, and IL-6 all decreased significantly in both groups after treatment, and there was no significant difference found between the two groups (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338403
03HumanRandomized controlled trialEfficacy outcome
In T2DM patients, IL-6 decreased in both groups without a significant difference between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, IL-6 fell in both groups without a significant difference between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeSerum IL-6
Study
n = 23
Comparator
Glimepiride
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
The levels of serum 8-iso-PGF2α, TNF-α, and IL-6 all decreased significantly in both groups after treatment, and there was no significant difference found between the two groups (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338404
04HumanRandomized controlled trialEfficacy outcome
In T2DM patients, mean blood glucose did not differ significantly between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, average blood glucose did not differ significantly between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMean blood glucose between groups
Study
n = 23
Comparator
Glimepiride
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Furthermore, no statistically significant difference was found between the two groups in MBG, SDBG, MAGE, and MODD (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338409
05HumanRandomized controlled trialEfficacy outcome
In T2DM patients, SDBG did not differ significantly between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, glucose variability did not differ significantly between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeSDBG between groups
Study
n = 23
Comparator
Glimepiride
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Furthermore, no statistically significant difference was found between the two groups in MBG, SDBG, MAGE, and MODD (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338410
06HumanRandomized controlled trialEfficacy outcome
In T2DM patients, MAGE did not differ significantly between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, the size of glucose swings did not differ significantly between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMAGE between groups
Study
n = 23
Comparator
Glimepiride
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Furthermore, no statistically significant difference was found between the two groups in MBG, SDBG, MAGE, and MODD (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338411
07HumanRandomized controlled trialEfficacy outcome
In T2DM patients, MODD did not differ significantly between dulaglutide and glimepiride.
In plain wordsIn T2DM patients, daily glucose differences did not differ significantly between dulaglutide and glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMODD between groups
Study
n = 23
Comparator
Glimepiride
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Furthermore, no statistically significant difference was found between the two groups in MBG, SDBG, MAGE, and MODD (P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338412
08HumanRandomized controlled trialEfficacy outcome
In T2DM patients, blood glucose standard deviation decreased significantly only in the dulaglutide group.
In plain wordsIn T2DM patients, glucose variability decreased significantly only in the dulaglutide group.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBlood glucose standard deviation change
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
SDBG
2.57 mmol/L
before dulaglutide
SDBG
1.98 mmol/L
after dulaglutide
Source sentences
Summary
However, the Standard Deviation of Blood Glucose (SDBG) decreased significantly only in the dulaglutide group (from 2.57 ± 0.74 mmol/L to 1.98 ± 0.74 mmol/L, P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
Show in the study text Report a problemFND-3118338406

Studies that did not test the peptide alone7

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).

09HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, HbA1c fell after dulaglutide, with a reduction also observed after glimepiride.
In plain wordsIn T2DM patients, HbA1c fell after dulaglutide and also after glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c
8.38%
before dulaglutide
HbA1c
6.68%
after dulaglutide
HbA1c
7.91%
before glimepiride
HbA1c
6.67%
after glimepiride
Source sentences
Summary
HbA1c of the dulaglutide group was reduced from 8.38 ± 0.93% to 6.68 ± 0.73% after the treatment (P P < 0.05) in the glimepiride group.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338401
10HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, mean blood glucose decreased after treatment in both groups, including dulaglutide.
In plain wordsIn T2DM patients, average blood glucose fell after treatment in both groups, including dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseMean blood glucose change
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The Mean Blood Glucose (MBG) of the two groups declined significantly after therapy (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338405
11HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, MAGE did not change significantly after dulaglutide or glimepiride treatment.
In plain wordsIn T2DM patients, the size of glucose swings did not change significantly after dulaglutide or glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMAGE change
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
There were no significant changes of Mean Amplitude of Glycemic Excursion (MAGE) and Absolute Means of Daily Difference (MODD) after treatment in both groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338407
12HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, MODD did not change significantly after dulaglutide or glimepiride treatment.
In plain wordsIn T2DM patients, daily glucose differences did not change significantly after dulaglutide or glimepiride.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMODD change
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
There were no significant changes of Mean Amplitude of Glycemic Excursion (MAGE) and Absolute Means of Daily Difference (MODD) after treatment in both groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338408
13HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, time above 10 mmol/L changed significantly after treatment in both groups, including dulaglutide, without a stated direction.
In plain wordsIn T2DM patients, time above 10 mmol/L changed in both groups, including dulaglutide. The abstract did not state the direction.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedTime above 10 mmol/L
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The percentage time (PT) (>10 mmol/L and 3.9-10 mmol/L) of the two groups was significantly changed after the treatment (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338413
14HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, time at 3.9-10 mmol/L changed significantly in both groups, including dulaglutide, without a stated direction.
In plain wordsIn T2DM patients, time at 3.9-10 mmol/L changed in both groups, including dulaglutide. The abstract did not state the direction.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedTime at 3.9-10 mmol/L
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The percentage time (PT) (>10 mmol/L and 3.9-10 mmol/L) of the two groups was significantly changed after the treatment (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338414
15HumanNot a test of Dulaglutide (Trulicity) aloneRandomized controlled trialEfficacy outcome
In T2DM patients, time below 3.9 mmol/L did not change significantly after treatment in either group, including dulaglutide.
In plain wordsIn T2DM patients, time below 3.9 mmol/L did not change significantly after treatment in either group, including dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeTime below 3.9 mmol/L
Study
n = 13
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
However, this was not seen in the PT P > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 23 patients with T2DM were randomly assigned into two groups for 26 weeks: the dulaglutide group (n = 13) and the glimepiride group (n = 10).
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).
Show in the study text Report a problemFND-3118338415

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 postedNCT01644500

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

Eli Lilly and Companyn = 737Jul 2012 to Aug 2014

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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