Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Sværke C, Yuen KCJ, Johannsson G

Pituitary15 Nov 2022Cited by 12 (Europe PMC)

PMID36380045PMCIDPMC9908671DOI10.1007/s11102-022-01283-3PepBankPUB-36380045

Summary

PurposeThe long-term effects of long-acting growth hormone (LAGH) analogues on glucose metabolism in adult growth hormone deficiency (AGHD) are not known. We investigated the impact of LAGH somapacitan, administered once-weekly, on glucose metabolism in patients with AGHD.MethodsIn post hoc-defined analyses, we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).ResultsNo new cases of diabetes mellitus were reported with somapacitan. Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks. HbA1c and HOMA-β did not differ between groups at either timepoint. Among treatment-naïve patients, sex, age, fasting insulin, glucose tolerance status and body mass index did not influence changes in glucose metabolism. In previously treated patients (REAL 1 extension: n = 51 somapacitan, n = 52 daily GH; REAL 2: n = 61 and n = 31, respectively; REAL Japan: n = 46 and n = 16, respectively), the difference in changes from baseline were not statistically significant between somapacitan and daily GH for any glucose metabolism parameters.ConclusionsSomapacitan, compared with daily GH, did not adversely affect glucose metabolism up to 86 weeks in a large cohort of treatment-naïve or previously treated patients with AGHD. Trial registrations (date of registration): NCT02229851 (2 September 2014), NCT02382939 (3 March 2015), NCT03075644 (7 March 2017).

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 GH-naïve adults, somapacitan produced a smaller FPG change than daily GH at 34 weeks.
In plain wordsIn GH-naïve adults, blood sugar changed less with somapacitan than daily GH at 34 weeks.
Peptide
Somapacitan
Outcome
DecreaseFPG change at 34 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004502
02HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, somapacitan produced a smaller HOMA-IR change than daily GH at 34 weeks.
In plain wordsIn GH-naïve adults, insulin resistance changed less with somapacitan than daily GH at 34 weeks.
Peptide
Somapacitan
Outcome
DecreaseHOMA-IR change at 34 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004503
03HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, somapacitan produced a smaller fasting insulin change than daily GH at 34 weeks.
In plain wordsIn GH-naïve adults, fasting insulin changed less with somapacitan than daily GH at 34 weeks.
Peptide
Somapacitan
Outcome
DecreaseFasting insulin change at 34 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004504
04HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, a higher FPG change with daily GH than with somapacitan was not observed at 86 weeks.
In plain wordsIn GH-naïve adults, daily GH did not show a higher blood sugar change than somapacitan at 86 weeks.
Peptide
Somapacitan
Outcome
No significant changeFPG change at 86 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004505
05HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, a higher HOMA-IR change with daily GH than with somapacitan was not observed at 86 weeks.
In plain wordsIn GH-naïve adults, daily GH did not show a higher insulin resistance change than somapacitan at 86 weeks.
Peptide
Somapacitan
Outcome
No significant changeHOMA-IR change at 86 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004506
06HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, a higher fasting insulin change with daily GH than with somapacitan was not observed at 86 weeks.
In plain wordsIn GH-naïve adults, daily GH did not show a higher fasting insulin change than somapacitan at 86 weeks.
Peptide
Somapacitan
Outcome
No significant changeFasting insulin change at 86 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004507
07HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, HbA1c did not differ between somapacitan and daily GH at either timepoint.
In plain wordsIn GH-naïve adults, HbA1c was similar with somapacitan and daily GH at both timepoints.
Peptide
Somapacitan
Outcome
No significant changeHbA1c at 34 and 86 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
HbA1c and HOMA-β did not differ between groups at either timepoint.
2 context sentences(design, population, supporting numbers)
Summary · context
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004508
08HumanRandomized controlled trialEfficacy outcome
In GH-naïve adults, HOMA-β did not differ between somapacitan and daily GH at either timepoint.
In plain wordsIn GH-naïve adults, beta-cell function was similar with somapacitan and daily GH at both timepoints.
Peptide
Somapacitan
Outcome
No significant changeHOMA-β at 34 and 86 weeks
Study
n = 239
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
HbA1c and HOMA-β did not differ between groups at either timepoint.
2 context sentences(design, population, supporting numbers)
Summary · context
Among GH-naïve patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks.
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004509
09HumanRandomized controlled trialEfficacy outcome
In previously treated adults, glucose metabolism changes did not differ significantly between somapacitan and daily GH.
In plain wordsIn previously treated adults, glucose metabolism changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
No significant changeGlucose metabolism parameters in previously treated patients
Study
n: not reported in source
Comparator
Daily GH
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
In previously treated patients (REAL 1 extension: n = 51 somapacitan, n = 52 daily GH; REAL 2: n = 61 and n = 31, respectively; REAL Japan: n = 46 and n = 16, respectively), the difference in changes from baseline were not statistically significant between somapacitan and daily GH for any glucose metabolism parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004511
10HumanNon-randomized trialSafety outcome
In adults with GH deficiency, no new diabetes cases occurred with somapacitan.
In plain wordsIn adults with GH deficiency, no new diabetes cases occurred with somapacitan.
Peptide
Somapacitan
Outcome
Not applicableNew diabetes mellitus
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
No new cases of diabetes mellitus were reported with somapacitan.
1 context sentence(design, population, supporting numbers)
Summary · context
we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).
Show in the study text Report a problemFND-3638004501

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

Registered trials3

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

3 trials · 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03075644

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 623 Mar 2017 to 4 Oct 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 23 Nov 2020

CompletedPhase 3Results postedNCT02382939

A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 9212 Feb 2015 to 4 Jan 2016

Adult Growth Hormone Deficiency · Growth Hormone Disorder

Trial page ClinicalTrials.govUpdated 9 Jul 2020

CompletedPhase 3Results postedNCT02229851

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Novo Nordisk A/Sn = 30131 Oct 2014 to 7 May 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 23 Nov 2020

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
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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