Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.

Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A

Diabetologia19 May 2017Cited by 97 (Europe PMC)

PMID28526920PMCIDPMC5491562DOI10.1007/s00125-017-4289-0PepBankPUB-28526920

Summary

Aims/hypothesisSemaglutide is a glucagon-like peptide-1 analogue in development for the treatment of type 2 diabetes. Its effects on first- and second-phase insulin secretion and other measures of beta cell function and glycaemic control were assessed.MethodsIn this single-centre, double-blind, placebo-controlled, parallel-group trial, conducted at the Profil Institut für Stoffwechselforschung, Germany, 75 adult (aged 18-64 years) participants with type 2 diabetes (eligibility: HbA_1c of 6.5-9.0% (47.5-74.9 mmol/mol); BMI 20.0-35.0 kg/m²; and treatment with diet and exercise and/or metformin monotherapy with a dose unchanged in the 30 days prior to screening) were randomised (1:1) to once-weekly s.c. semaglutide 1.0 mg (0.25, 0.5, 1.0 mg escalated) or placebo for 12 weeks. Co-primary endpoints were changes from baseline to end of treatment in the first (AUC_{0-10 min}) and second (AUC_{10-120 min}) insulin secretion phases, as measured by the IVGTT. An arginine stimulation test (AST) and a 24 h meal stimulation test were also conducted. A graded glucose infusion test (GGIT) assessed insulin secretion rate (ISR) in treated participants and a group of untreated healthy participants. Safety endpoints were also assessed.ResultsIn total, 37 participants received semaglutide and 38 received placebo. Following IVGTT, for insulin, both AUC_0-10min and AUC_10-120min were significantly increased with semaglutide (estimated treatment ratio [95% CI] 3.02 [2.53, 3.60] and 2.10 [1.86, 2.37], respectively; p < 0.0001). The 24 h meal test showed reduced fasting, postprandial and overall (AUC_0-24h) glucose and glucagon responses with semaglutide (p < 0.0001). The AST showed that maximal insulin capacity increased following semaglutide treatment. During GGIT, semaglutide significantly increased ISR to levels similar to those in healthy participants. Semaglutide was well tolerated.Conclusions/interpretationTwelve weeks of once-weekly treatment with semaglutide significantly improved beta cell function and glycaemic control in participants with type 2 diabetes.Trial registrationClinicalTrials.gov NCT02212067 FUNDING: The study was funded by Novo Nordisk A/S.

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

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide increased first-phase insulin secretion after IVGTT versus placebo (treatment ratio 3.02).
In plain wordsIn adults with type 2 diabetes, semaglutide raised early insulin release after a glucose challenge compared with placebo.
Peptide
Semaglutide
Outcome
IncreaseFirst-phase insulin secretion (AUC 0-10 min)
Study
n = 75
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Estimated treatment ratio
3.02 ratio
AUC0-10min insulin
Source sentences
Summary
Following IVGTT, for insulin, both AUC_0-10min and AUC_10-120min were significantly increased with semaglutide (estimated treatment ratio [95% CI] 3.02 [2.53, 3.60] and 2.10 [1.86, 2.37], respectively; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692001
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide increased second-phase insulin secretion after IVGTT versus placebo (treatment ratio 2.10).
In plain wordsIn adults with type 2 diabetes, semaglutide raised later insulin release after a glucose challenge compared with placebo.
Peptide
Semaglutide
Outcome
IncreaseSecond-phase insulin secretion (AUC 10-120 min)
Study
n = 75
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Estimated treatment ratio
2.1 ratio
AUC10-120min insulin
Source sentences
Summary
Following IVGTT, for insulin, both AUC_0-10min and AUC_10-120min were significantly increased with semaglutide (estimated treatment ratio [95% CI] 3.02 [2.53, 3.60] and 2.10 [1.86, 2.37], respectively; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692002
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide reduced fasting, postprandial and overall glucose in the 24 h meal test versus placebo.
In plain wordsIn adults with type 2 diabetes, semaglutide lowered fasting and after-meal glucose over 24 hours compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseGlucose responses in the 24 h meal test
Study
n = 75
Comparator
Placebo
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The 24 h meal test showed reduced fasting, postprandial and overall (AUC_0-24h) glucose and glucagon responses with semaglutide (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692003
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide reduced fasting, postprandial and overall glucagon responses in the 24 h meal test versus placebo.
In plain wordsIn adults with type 2 diabetes, semaglutide lowered glucagon levels over 24 hours compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseGlucagon responses in the 24 h meal test
Study
n = 75
Comparator
Placebo
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The 24 h meal test showed reduced fasting, postprandial and overall (AUC_0-24h) glucose and glucagon responses with semaglutide (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692004
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, maximal insulin capacity in the arginine stimulation test increased after semaglutide treatment.
In plain wordsIn adults with type 2 diabetes, the maximum insulin the body could release rose after semaglutide treatment.
Peptide
Semaglutide
Outcome
IncreaseMaximal insulin capacity in the arginine stimulation test
Study
n = 75
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The AST showed that maximal insulin capacity increased following semaglutide treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692005
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, semaglutide was well tolerated over 12 weeks.
In plain wordsIn adults with type 2 diabetes, semaglutide was well tolerated over 12 weeks.
Peptide
Semaglutide
Outcome
Not applicableTolerability
Study
n = 75
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide was well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692007
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide increased insulin secretion rate in the graded glucose infusion test to levels similar to those in healthy participants.
In plain wordsIn adults with type 2 diabetes, semaglutide raised insulin release to levels similar to those in healthy people.
Peptide
Semaglutide
Outcome
IncreaseInsulin secretion rate during graded glucose infusion
Study
n: not reported in source
Comparator
Untreated healthy participants
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
1.0 mg once weekly (escalated 0.25, 0.5, 1.0 mg) · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
During GGIT, semaglutide significantly increased ISR to levels similar to those in healthy participants.
1 context sentence(design, population, supporting numbers)
Summary · context
75 adult (aged 18-64 years) participants with type 2 diabetes
Show in the study text Report a problemFND-2852692006

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02212067

A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 8711 Aug 2014 to 11 May 2015

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 7 Mar 2018

CompletedPhase 3Results postedNCT02128932

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 1,0894 Aug 2014 to 3 Sept 2015

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 13 Jun 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
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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