Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes.

Mirabelli M, Chiefari E, Tocci V, Caroleo P, Giuliano S, Greco E, Luque RM, Puccio L, Foti DP, Aversa A, Brunetti A

Journal of clinical medicine2 Mar 2021Cited by 26 (Europe PMC)

PMID33801192PMCIDPMC7957905DOI10.3390/jcm10050985PepBankPUB-33801192

Summary

Aims and methodsThe aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D). Comparative efficacy versus liraglutide (LIRA) 1.2-1.8 mg/once daily in a study sample naïve to GLP-1 RAs, frequency matching for age, gender, T2D duration, degree of glycemic impairment, cardiovascular comorbidities, and medications, was addressed as a secondary aim. Clinical and biochemical data for efficacy outcomes and information on drug discontinuation due to adverse events (AEs) were collected from digital records.ResultsInitial analysis included 126 overweight and obese T2D patients (48.4% females). Out of these, 13 discontinued DU due to moderate-severe gastrointestinal AEs after a mean follow-up of 6 (4 standard deviations (SD)) months, while 65 completed 18 months of continuous therapy. At 6 months, there was a significant mean HbA1c reduction of -0.85% (1.17 SD) with respect to baseline values (p < 0.001), which remained stable during 18 months follow-up. These results were accompanied by a moderate weight loss sustained over time, with a mean reduction of -2.0% (4.3 SD) at 6 months and -1.3% (4.8 SD) at 18 months (p = 0.091). At univariate analysis, a negative correlation between baseline body mass index (BMI) and risk of drug discontinuation due to gastrointestinal AEs was observed. The protective effect of obesity against drug discontinuation was confirmed by logistic regression analysis. Neither gender, nor age, nor T2D duration, nor concomitant conventional insulin secretagogue use, nor switching to DU from other GLP-1 RAs influenced its long-term effectiveness. However, higher baseline HbA1c values emerged as predictors of clinically relevant efficacy outcomes, either in terms of HbA1c reduction ≥ 0.5% or body weight loss ≥ 5%. The efficacy outcomes were corroborated by head-to-head comparison with LIRA, a GLP-1 RA with durable beneficial effects on glycemic control and body weight in real-world experiences. With the advantage of once-weekly administration, at 18-month follow-up, a significantly larger fraction of patients on DU therapy reached glycemic targets (HbA1c ≤ 7.0%) when compared to those on LIRA: from 14.8% at baseline (both groups) to 64.8% with DU and 42.6% with LIRA (p = 0.033).ConclusionsAlthough limited by a retrospective design and lack of constant up-titration for LIRA to the highest dose, these findings indicate that the beneficial responses to DU on a background of MET or MET plus insulin secretagogues are durable, especially in the presence of obesity and greater HbA1c impairment.

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

Results from this study10

6 results from studies that gave the peptide. 6 results from people.

01HumanObservational studyEfficacy outcome
In patients with type 2 diabetes, dulaglutide was linked to greater HbA1c target attainment than liraglutide at 18 months.
In plain wordsIn patients with diabetes, dulaglutide was linked to more patients reaching the blood sugar target than liraglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c target attainment
Study
n: not reported in source
Comparator
Liraglutide
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 18 monthsAs given in this study (human).
Measurements
HbA1c target attainment
64.8%
dulaglutide
HbA1c target attainment
42.6%
liraglutide
Source sentences
Summary
With the advantage of once-weekly administration, at 18-month follow-up, a significantly larger fraction of patients on DU therapy reached glycemic targets (HbA1c ≤ 7.0%) when compared to those on LIRA: from 14.8% at baseline (both groups) to 64.8% with DU and 42.6% with LIRA (p = 0.033).
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119209
02HumanObservational studyEfficacy outcome
In patients with type 2 diabetes, liraglutide was linked to lower HbA1c target attainment than dulaglutide at 18 months.
In plain wordsIn patients with diabetes, liraglutide was linked to fewer patients reaching the blood sugar target than dulaglutide.
Peptide
Liraglutide
Outcome
DecreaseHbA1c target attainment
Study
n: not reported in source
Comparator
Dulaglutide
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2-1.8 mg once daily · 18 monthsAs given in this study (human).
Measurements
HbA1c target attainment
42.6%
liraglutide
HbA1c target attainment
64.8%
dulaglutide
Source sentences
Summary
With the advantage of once-weekly administration, at 18-month follow-up, a significantly larger fraction of patients on DU therapy reached glycemic targets (HbA1c ≤ 7.0%) when compared to those on LIRA: from 14.8% at baseline (both groups) to 64.8% with DU and 42.6% with LIRA (p = 0.033).
2 context sentences(design, population, supporting numbers)
Summary · context
Comparative efficacy versus liraglutide (LIRA) 1.2-1.8 mg/once daily in a study sample naïve to GLP-1 RAs, frequency matching for age, gender, T2D duration, degree of glycemic impairment, cardiovascular comorbidities, and medications, was addressed as a secondary aim.
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119210
03HumanObservational studySafety outcome
In overweight or obese patients with type 2 diabetes, 13 stopped dulaglutide because of moderate-severe gastrointestinal adverse events.
In plain wordsIn patients with diabetes and excess weight, 13 stopped dulaglutide because of moderate-severe digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiscontinuation due to gastrointestinal adverse events
Study
n = 126
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weeklyAs given in this study (human).
Measurements
Discontinuations
13 patients
dulaglutide
Source sentences
Summary
Out of these, 13 discontinued DU due to moderate-severe gastrointestinal AEs after a mean follow-up of 6 (4 standard deviations (SD)) months, while 65 completed 18 months of continuous therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
Initial analysis included 126 overweight and obese T2D patients (48.4% females).
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119201
04HumanObservational studyEfficacy outcome
In patients with type 2 diabetes, dulaglutide use was linked to a mean weight reduction at 18 months.
In plain wordsIn patients with diabetes, dulaglutide use was linked to lower weight at 18 months compared with baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change at 18 months
Study
n = 65
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · 18 monthsAs given in this study (human).
Measurements
Weight change
−1.3%
18 months
Source sentences
Summary
These results were accompanied by a moderate weight loss sustained over time, with a mean reduction of -2.0% (4.3 SD) at 6 months and -1.3% (4.8 SD) at 18 months (p = 0.091).
2 context sentences(design, population, supporting numbers)
Summary · context
Out of these, 13 discontinued DU due to moderate-severe gastrointestinal AEs after a mean follow-up of 6 (4 standard deviations (SD)) months, while 65 completed 18 months of continuous therapy.
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119204
05HumanObservational studyEfficacy outcome
In patients with type 2 diabetes, dulaglutide use was linked to lower HbA1c at 6 months, maintained during follow-up.
In plain wordsIn patients with diabetes, dulaglutide use was linked to lower blood sugar compared with baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 6 monthsAs given in this study (human).
Measurements
HbA1c change
−0.85%
6 months
Source sentences
Summary
At 6 months, there was a significant mean HbA1c reduction of -0.85% (1.17 SD) with respect to baseline values (p < 0.001), which remained stable during 18 months follow-up.
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119202
06HumanObservational studyEfficacy outcome
In patients with type 2 diabetes, dulaglutide use was linked to a mean weight reduction at 6 months.
In plain wordsIn patients with diabetes, dulaglutide use was linked to lower weight at 6 months compared with baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBody weight change at 6 months
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · 6 monthsAs given in this study (human).
Measurements
Weight change
−2%
6 months
Source sentences
Summary
These results were accompanied by a moderate weight loss sustained over time, with a mean reduction of -2.0% (4.3 SD) at 6 months and -1.3% (4.8 SD) at 18 months (p = 0.091).
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
Show in the study text Report a problemFND-3380119203

Studies that did not test the peptide alone4

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).

07HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In patients receiving dulaglutide, higher baseline BMI was linked to lower gastrointestinal discontinuation risk, including in logistic regression.
In plain wordsIn patients receiving dulaglutide, higher starting BMI was linked to lower risk of stopping treatment because of digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBMI and gastrointestinal discontinuation risk
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
At univariate analysis, a negative correlation between baseline body mass index (BMI) and risk of drug discontinuation due to gastrointestinal AEs was observed. The protective effect of obesity against drug discontinuation was confirmed by logistic regression analysis.
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
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-3380119205
08HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In patients receiving dulaglutide, gender, age, diabetes duration, insulin secretagogue use and prior GLP-1 therapy did not influence long-term effectiveness.
In plain wordsIn patients receiving dulaglutide, age, gender, diabetes duration, insulin secretagogue use and prior GLP-1 treatment did not influence long-term effectiveness.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeLong-term effectiveness predictors
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
Neither gender, nor age, nor T2D duration, nor concomitant conventional insulin secretagogue use, nor switching to DU from other GLP-1 RAs influenced its long-term effectiveness.
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
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-3380119206
09HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In patients receiving dulaglutide, higher baseline HbA1c predicted an HbA1c reduction of at least 0.5%.
In plain wordsIn patients receiving dulaglutide, higher starting HbA1c was linked to a greater chance of a clinically relevant blood sugar reduction.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBaseline HbA1c and HbA1c response
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
However, higher baseline HbA1c values emerged as predictors of clinically relevant efficacy outcomes, either in terms of HbA1c reduction ≥ 0.5% or body weight loss ≥ 5%.
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
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-3380119207
10HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In patients receiving dulaglutide, higher baseline HbA1c predicted body weight loss of at least 5%.
In plain wordsIn patients receiving dulaglutide, higher starting HbA1c was linked to a greater chance of clinically relevant weight loss.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBaseline HbA1c and weight response
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
However, higher baseline HbA1c values emerged as predictors of clinically relevant efficacy outcomes, either in terms of HbA1c reduction ≥ 0.5% or body weight loss ≥ 5%.
1 context sentence(design, population, supporting numbers)
Summary · context
The aim of this monocentric retrospective observational study was to evaluate the 18-month safety and effectiveness of GLP-1 receptor agonist (GLP-1 RA) dulaglutide (DU) 1.5 mg/once weekly as an add-on to metformin (MET) or MET plus conventional insulin secretagogues in a study cohort with excess body weight and type 2 diabetes (T2D).
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-3380119208

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.

Version 3Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 2
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes.

Summary

Results from this study10

Studies that did not test the peptide alone4

Version history

Subjects

Publication types

Keywords