Lixisenatide in type 1 diabetes: A randomised control trial of the effect of lixisenatide on post-meal glucose excursions and glucagon in type 1 diabetes patients.

Ballav C, Dhere A, Kennedy I, Agbaje OF, White S, Franklin R, Hartmann B, Holst JJ, Holman RR, Owen KR

Endocrinology, diabetes & metabolism12 Jun 2020Cited by 8 (Europe PMC)

PMID32704555PMCIDPMC7375047DOI10.1002/edm2.130PepBankPUB-32704555

Summary

AimsThe GLP1 agonist lixisenatide is glucagonostatic and reduces post-prandial blood glucose (PPBG) in type 2 diabetes. This study investigates its impact in type 1 diabetes (T1D).MethodsIn a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period. The primary outcome was percentage of 3 hours PPBG in target (4-10 mmol/L) assessed by CGM before and after treatment. Participants also underwent post-treatment standardised mixed meal test (MMT, n = 25) and hyperinsulinaemic hypoglycaemic clamp (n = 15).ResultsPPBG CGM readings in target were similar between L vs P (Mean % ± SE, breakfast 45.4 ± 6.0 vs 44.3 ± 6.0, P = .48, lunch 45.5 ± 5.8 vs 50.6 ± 5.3, P = .27 and dinner 43.0 ± 6.7 vs 47.7 ± 5.6, P = .30). HbA1C was similar between L vs P (64.7 ± 1.6 vs 64.1 ± 1.6 mmol/mol, P = .30). Prandial insulin fell after lixisenatide (dose change -0.7 ± 0.6 vs +2.4 ± 0.7 units/d, P = .004), but basal insulin dose was similar between groups. The post-MMT glucose area under the curve (AUC) was lower with L than P (392.0 ± 167.7 vs 628.1 ± 132.5 mmol/L × min, P < .001), as was the corresponding glucagon AUC (140.0 ± 110.0 vs 304.2 ± 148.2 nmol/L × min, P < .001). Glucagon and counter-regulatory hormone values at a blood glucose of 2.4 mmol/L during the hypoglycaemic clamp were similar between L and P.ConclusionIn T1D, PPBG values were not altered by adjunctive lixisenatide although prandial insulin dose fell. Glucose and glucagon level during an MMT were significantly lower after lixisenatide, without affecting counter-regulatory response during hypoglycaemia.

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

Results from this study10

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

01HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, breakfast glucose time in target was similar with lixisenatide (45.4 ± 6.0%) and placebo (44.3 ± 6.0%; P = .48), numerically higher with lixisenatide.
In plain wordsIn type 1 diabetes, breakfast glucose time in target was similar with lixisenatide and placebo, numerically higher with lixisenatide.
Peptide
Lixisenatide
Outcome
IncreaseBreakfast post-meal glucose time in target
Study
n = 25
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Mean breakfast PPBG time in target
45.4%
lixisenatide; SE 6.0
Mean breakfast PPBG time in target
44.3%
placebo; SE 6.0
P value (breakfast time in target)
0.48 P
lixisenatide vs placebo
Source sentences
Summary
PPBG CGM readings in target were similar between L vs P (Mean % ± SE, breakfast 45.4 ± 6.0 vs 44.3 ± 6.0, P = .48, lunch 45.5 ± 5.8 vs 50.6 ± 5.3, P = .27 and dinner 43.0 ± 6.7 vs 47.7 ± 5.6, P = .30).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455501
02HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, lunch glucose time in target was similar with lixisenatide (45.5 ± 5.8%) and placebo (50.6 ± 5.3%; P = .27), numerically lower with lixisenatide.
In plain wordsIn type 1 diabetes, lunch glucose time in target was similar with lixisenatide and placebo, numerically lower with lixisenatide.
Peptide
Lixisenatide
Outcome
DecreaseLunch post-meal glucose time in target
Study
n = 25
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Mean lunch PPBG time in target
45.5%
lixisenatide; SE 5.8
Mean lunch PPBG time in target
50.6%
placebo; SE 5.3
P value (lunch time in target)
0.27 P
lixisenatide vs placebo
Source sentences
Summary
PPBG CGM readings in target were similar between L vs P (Mean % ± SE, breakfast 45.4 ± 6.0 vs 44.3 ± 6.0, P = .48, lunch 45.5 ± 5.8 vs 50.6 ± 5.3, P = .27 and dinner 43.0 ± 6.7 vs 47.7 ± 5.6, P = .30).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455502
03HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, dinner glucose time in target was similar with lixisenatide (43.0 ± 6.7%) and placebo (47.7 ± 5.6%; P = .30), numerically lower with lixisenatide.
In plain wordsIn type 1 diabetes, dinner glucose time in target was similar with lixisenatide and placebo, numerically lower with lixisenatide.
Peptide
Lixisenatide
Outcome
DecreaseDinner post-meal glucose time in target
Study
n = 25
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Mean dinner PPBG time in target
43%
lixisenatide; SE 6.7
Mean dinner PPBG time in target
47.7%
placebo; SE 5.6
P value (dinner time in target)
0.3 P
lixisenatide vs placebo
Source sentences
Summary
PPBG CGM readings in target were similar between L vs P (Mean % ± SE, breakfast 45.4 ± 6.0 vs 44.3 ± 6.0, P = .48, lunch 45.5 ± 5.8 vs 50.6 ± 5.3, P = .27 and dinner 43.0 ± 6.7 vs 47.7 ± 5.6, P = .30).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455503
04HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, HbA1C was similar with lixisenatide (64.7 ± 1.6 mmol/mol) and placebo (64.1 ± 1.6 mmol/mol; P = .30), numerically higher with lixisenatide.
In plain wordsIn type 1 diabetes, HbA1c was similar with lixisenatide and placebo, numerically higher with lixisenatide.
Peptide
Lixisenatide
Outcome
IncreaseHbA1C
Study
n = 25
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
HbA1C
64.7 mmol/mol
lixisenatide; ± 1.6 as reported
HbA1C
64.1 mmol/mol
placebo; ± 1.6 as reported
P value (HbA1C)
0.3 P
lixisenatide vs placebo
Source sentences
Summary
HbA1C was similar between L vs P (64.7 ± 1.6 vs 64.1 ± 1.6 mmol/mol, P = .30).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455504
05HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, prandial insulin changed by -0.7 ± 0.6 units/d with lixisenatide versus +2.4 ± 0.7 units/d with placebo (P = .004).
In plain wordsIn type 1 diabetes, lixisenatide reduced mealtime insulin dose compared with placebo.
Peptide
Lixisenatide
Outcome
DecreasePrandial insulin dose change
Study
n = 25
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Prandial insulin dose change
−0.7 units/d
lixisenatide; ± 0.6 as reported
Prandial insulin dose change
2.4 units/d
placebo; ± 0.7 as reported
P value (prandial insulin dose change)
0.004 P
lixisenatide vs placebo
Source sentences
Summary
Prandial insulin fell after lixisenatide (dose change -0.7 ± 0.6 vs +2.4 ± 0.7 units/d, P = .004), but basal insulin dose was similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455505
06HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, basal insulin dose was similar between lixisenatide and placebo.
In plain wordsIn type 1 diabetes, basal insulin dose was similar with lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedBasal insulin dose
Study
n = 25
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Source sentences
Summary
Prandial insulin fell after lixisenatide (dose change -0.7 ± 0.6 vs +2.4 ± 0.7 units/d, P = .004), but basal insulin dose was similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455506
07HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, glucose AUC was 392.0 ± 167.7 with lixisenatide versus 628.1 ± 132.5 mmol/L × min with placebo (P < .001).
In plain wordsIn type 1 diabetes, lixisenatide reduced glucose exposure after a mixed meal compared with placebo.
Peptide
Lixisenatide
Outcome
DecreasePost-MMT glucose AUC
Study
n = 25
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Post-MMT glucose AUC
392 mmol/L × min
lixisenatide; ± 167.7 as reported
Post-MMT glucose AUC
628.1 mmol/L × min
placebo; ± 132.5 as reported
P value (post-MMT glucose AUC)
< 0.001 P
lixisenatide vs placebo
Source sentences
Summary
The post-MMT glucose area under the curve (AUC) was lower with L than P (392.0 ± 167.7 vs 628.1 ± 132.5 mmol/L × min, P < .001), as was the corresponding glucagon AUC (140.0 ± 110.0 vs 304.2 ± 148.2 nmol/L × min, P < .001).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455507
08HumanRandomized controlled trialMechanism
In type 1 diabetes, glucagon AUC was 140.0 ± 110.0 with lixisenatide versus 304.2 ± 148.2 nmol/L × min with placebo (P < .001).
In plain wordsIn type 1 diabetes, lixisenatide reduced glucagon exposure after a mixed meal compared with placebo.
Peptide
Lixisenatide
Outcome
DecreasePost-MMT glucagon AUC
Study
n = 25
Comparator
Placebo
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Measurements
Post-MMT glucagon AUC
140 nmol/L × min
lixisenatide; ± 110.0 as reported
Post-MMT glucagon AUC
304.2 nmol/L × min
placebo; ± 148.2 as reported
P value (post-MMT glucagon AUC)
< 0.001 P
lixisenatide vs placebo
Source sentences
Summary
The post-MMT glucose area under the curve (AUC) was lower with L than P (392.0 ± 167.7 vs 628.1 ± 132.5 mmol/L × min, P < .001), as was the corresponding glucagon AUC (140.0 ± 110.0 vs 304.2 ± 148.2 nmol/L × min, P < .001).
1 context sentence(design, population, supporting numbers)
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455508
09HumanRandomized controlled trialSafety outcome
In type 1 diabetes, glucagon at blood glucose 2.4 mmol/L during a hypoglycaemic clamp was similar with lixisenatide and placebo.
In plain wordsIn type 1 diabetes, glucagon during induced low blood sugar was similar with lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedGlucagon during hypoglycaemic clamp
Study
n = 15
Comparator
Placebo
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Source sentences
Summary
Glucagon and counter-regulatory hormone values at a blood glucose of 2.4 mmol/L during the hypoglycaemic clamp were similar between L and P.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants also underwent post-treatment standardised mixed meal test (MMT, n = 25) and hyperinsulinaemic hypoglycaemic clamp (n = 15).
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455509
10HumanRandomized controlled trialSafety outcome
In type 1 diabetes, counter-regulatory hormones at blood glucose 2.4 mmol/L during a hypoglycaemic clamp were similar with lixisenatide and placebo.
In plain wordsIn type 1 diabetes, counter-regulatory hormones during induced low blood sugar were similar with lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedCounter-regulatory hormones during hypoglycaemic clamp
Study
n = 15
Comparator
Placebo
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
Dose not stated · 4 weeksAs given in this study (human).
Source sentences
Summary
Glucagon and counter-regulatory hormone values at a blood glucose of 2.4 mmol/L during the hypoglycaemic clamp were similar between L and P.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants also underwent post-treatment standardised mixed meal test (MMT, n = 25) and hyperinsulinaemic hypoglycaemic clamp (n = 15).
Summary · context
In a blinded, crossover trial, 25 patients with T1D were randomised to 4 weeks adjunctive treatment with lixisenatide (L) or placebo (P), with a 4-week washout period.
Show in the study text Report a problemFND-3270455510

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Version history

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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