Randomised placebo-controlled trial of human recombinant insulin-like growth factor I plus intensive insulin therapy in adolescents with insulin-dependent diabetes mellitus.

Acerini CL, Patton CM, Savage MO, Kernell A, Westphal O, Dunger DB

Lancet (London, England)1 Oct 1997Cited by 60 (Europe PMC)

PMID9652560DOI10.1016/s0140-6736(97)06467-2PepBankPUB-09652560

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adolescents with IDDM, adding rhIGF-I to insulin therapy reduced HbA1c versus placebo plus insulin therapy.
In plain wordsIn adolescents with IDDM, adding rhIGF-I to insulin therapy reduced HbA1c versus placebo plus insulin therapy.
Peptide
IGF-1 (mecasermin)
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
Placebo plus multiple-injection insulin therapy
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Measurements
P value for HbA1c reduction versus placebo
0.03 unitless
rhIGF-I 40 microg/kg daily plus insulin therapy versus placebo plus insulin therapy
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
3 context sentences(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Summary · context
The primary endpoint, glycated haemoglobin (HbA1c) and routine biochemistry were measured every 4 weeks.
Summary · context
Data were analysed by intention to treat.
Report a problemFND-0965256001
02HumanRandomized controlled trialSafety outcome
In adolescents with IDDM, retinal photographs showed no adverse events during the rhIGF-I trial.
In plain wordsIn adolescents with IDDM, retinal photographs showed no adverse events during the rhIGF-I trial.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeRetinal adverse events
Study
n = 53
Outcome group
Adverse events · Eye
Studied dose
20 or 40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Retinal photographs, renal function (glomerular filtration rate and urinary albumin excretion), and routine biochemistry showed no adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256010
03HumanRandomized controlled trialSafety outcome
In adolescents with IDDM, glomerular filtration assessments showed no adverse events during the rhIGF-I trial.
In plain wordsIn adolescents with IDDM, kidney filtration assessments showed no adverse events during the rhIGF-I trial.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeGlomerular filtration adverse events
Study
n = 53
Outcome group
Kidney function · Kidney and urinary
Studied dose
20 or 40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Retinal photographs, renal function (glomerular filtration rate and urinary albumin excretion), and routine biochemistry showed no adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256011
04HumanRandomized controlled trialSafety outcome
In adolescents with IDDM, urinary albumin assessments showed no adverse events during the rhIGF-I trial.
In plain wordsIn adolescents with IDDM, urinary albumin assessments showed no adverse events during the rhIGF-I trial.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeUrinary albumin adverse events
Study
n = 53
Outcome group
Kidney function · Kidney and urinary
Studied dose
20 or 40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Retinal photographs, renal function (glomerular filtration rate and urinary albumin excretion), and routine biochemistry showed no adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256012
05HumanRandomized controlled trialSafety outcome
In adolescents with IDDM, routine biochemistry showed no adverse events during the rhIGF-I trial.
In plain wordsIn adolescents with IDDM, routine biochemistry showed no adverse events during the rhIGF-I trial.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeRoutine biochemistry adverse events
Study
n = 53
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 or 40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Retinal photographs, renal function (glomerular filtration rate and urinary albumin excretion), and routine biochemistry showed no adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256013
06HumanRandomized controlled trialEfficacy outcome
In adolescents with IDDM, the greatest median HbA1c change with rhIGF-I was -0.6% at week 12.
In plain wordsIn adolescents with IDDM, the greatest median HbA1c change with rhIGF-I was -0.6% at week 12.
Peptide
IGF-1 (mecasermin)
Outcome
DecreaseHbA1c change at week 12
Study
n = 18
Outcome group
Glycemic control · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Measurements
median HbA1c change
−0.6%
rhIGF-I 40 microg/kg, week 12
HbA1c change range
−2.8 to −1.5%
rhIGF-I 40 microg/kg, week 12
Source sentences
Summary
The greatest median change in HbA1c of -0.6% (range -2.8 to -1.5%) was seen with rhIGF-I 40 microg/kg at week 12, but was not sustained at week 24.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256007
07HumanRandomized controlled trialEfficacy outcome
In adolescents with IDDM, the week 12 HbA1c reduction with rhIGF-I was not sustained at week 24.
In plain wordsIn adolescents with IDDM, the HbA1c reduction with rhIGF-I was not sustained at week 24.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeHbA1c benefit persistence
Study
n = 18
Outcome group
Glycemic control · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
The greatest median change in HbA1c of -0.6% (range -2.8 to -1.5%) was seen with rhIGF-I 40 microg/kg at week 12, but was not sustained at week 24.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256008
08HumanRandomized controlled trialEfficacy outcome
In adolescents with IDDM receiving insulin therapy, rhIGF-I did not change body-mass index compared with placebo.
In plain wordsIn adolescents with IDDM receiving insulin therapy, rhIGF-I did not change body-mass index compared with placebo.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeBody-mass index
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256002
09HumanRandomized controlled trialSafety outcome
In adolescents with IDDM receiving insulin therapy, rhIGF-I did not change hypoglycaemia rate compared with placebo.
In plain wordsIn adolescents with IDDM receiving insulin therapy, rhIGF-I did not change low blood sugar rate compared with placebo.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeHypoglycaemia rate
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256003
10HumanRandomized controlled trialEfficacy outcome
In adolescents with IDDM receiving insulin therapy, rhIGF-I did not change insulin dose compared with placebo.
In plain wordsIn adolescents with IDDM receiving insulin therapy, rhIGF-I did not change insulin dose compared with placebo.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeInsulin dose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256004
11HumanRandomized controlled trialMechanism
In adolescents with IDDM receiving insulin therapy, rhIGF-I did not change circulating IGF-binding protein 1 compared with placebo.
In plain wordsIn adolescents with IDDM receiving insulin therapy, rhIGF-I did not change circulating IGF-binding protein 1 compared with placebo.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeIGF-binding protein 1
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256005
12HumanRandomized controlled trialMechanism
In adolescents with IDDM receiving insulin therapy, rhIGF-I did not change circulating IGF-binding protein 3 compared with placebo.
In plain wordsIn adolescents with IDDM receiving insulin therapy, rhIGF-I did not change circulating IGF-binding protein 3 compared with placebo.
Peptide
IGF-1 (mecasermin)
Outcome
No significant changeIGF-binding protein 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Metabolic and weight
Studied dose
40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
With a dose of 40 microg/kg rhIGF-I daily, we found significant reductions in HbA1c compared with placebo (p=0.03), without changes in body-mass index, rate of hypoglycaemia, insulin dose, or circulating concentrations of IGF-binding proteins 1 and 3.
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256006
13HumanObservational studyMechanism
In adolescents with IDDM, greater changes in IGF-I concentrations were associated with greater HbA1c reductions at week 24.
In plain wordsIn adolescents with IDDM, greater IGF-I changes were linked to greater HbA1c reductions at week 24.
Peptide
IGF-1 (mecasermin)
Outcome
DecreaseIGF-I change and HbA1c reduction
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 or 40 microg/kg daily · subcutaneous · 24 weeksAs given in this study (human).
Measurements
P value for association between IGF-I concentration changes and HbA1c reductions
0.002 unitless
IGF-I concentration changes and HbA1c reductions at week 24
Source sentences
Summary
The greatest reductions in HbA1c at week 24 were seen among patients with the greatest changes in IGF-I concentrations (r=-0442, p=0.002).
1 context sentence(design, population, supporting numbers)
Summary · context
53 patients with IDDM (26 male, 27 female) with a median age of 16.1 years (range 10.8-20.6) and diabetes of more than 2 years' duration were randomly assigned subcutaneous rhIGF-I (20 or 40 microg/kg daily [n=18, n=18, respectively]) or placebo (n=17), both in addition to multiple-injection insulin…
Report a problemFND-0965256009

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 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

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