Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial.

Clemmons DR, Miller S, Mamputu JC

PloS one15 Jun 2017Cited by 15 (Europe PMC)

PMID28617838PMCIDPMC5472315DOI10.1371/journal.pone.0179538PepBankPUB-28617838

Summary

ObjectiveUse of growth hormone is associated with side effects, including insulin resistance. The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.DesignA 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.MeasurementsFasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemoglobin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids.Main outcome measureRelative insulin response following oral ingestion of glucose.ResultsNo significant differences were observed between groups in relative insulin response over the 12-week treatment period. At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups. In addition, relevant modifications in diabetes medications were similar between groups. Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo). No patient discontinued the study due to loss of diabetes control.ConclusionsTreatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.Trial registrationClinicalTrials.gov NCT01264497.

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

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, tesamorelin did not change relative insulin response versus placebo over 12 weeks.
In plain wordsIn adults with type 2 diabetes, tesamorelin did not change the insulin response to sugar compared with placebo.
Peptide
Tesamorelin
Outcome
No significant changeRelative insulin response after oral glucose
Study
n = 53
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
No significant differences were observed between groups in relative insulin response over the 12-week treatment period.
3 context sentences(design, population, supporting numbers)
Summary · context
Relative insulin response following oral ingestion of glucose.
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783801
02HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, fasting glucose at week 12 did not differ significantly between tesamorelin and placebo.
In plain wordsIn adults with type 2 diabetes, tesamorelin did not change fasting blood sugar compared with placebo.
Peptide
Tesamorelin
Outcome
No significant changeFasting glucose at week 12
Study
n = 53
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
At Week 12, fasting glucose
3 context sentences(design, population, supporting numbers)
Summary · context
At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups.
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783802
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, HbA1c at week 12 did not differ significantly between tesamorelin and placebo.
In plain wordsIn adults with type 2 diabetes, tesamorelin did not change long-term blood sugar compared with placebo.
Peptide
Tesamorelin
Outcome
No significant changeHbA1c at week 12
Study
n = 53
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783803
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, overall diabetes control at week 12 did not differ significantly between tesamorelin and placebo.
In plain wordsIn adults with type 2 diabetes, overall diabetes control was not different with tesamorelin compared with placebo.
Peptide
Tesamorelin
Outcome
No significant changeOverall diabetes control at week 12
Study
n = 53
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783804
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, relevant modifications in diabetes medications were similar between tesamorelin and placebo groups.
In plain wordsIn adults with type 2 diabetes, changes in diabetes medicines were similar with tesamorelin and with placebo.
Peptide
Tesamorelin
Outcome
No significant changeModifications in diabetes medications
Study
n = 53
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
In addition, relevant modifications in diabetes medications were similar between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783805
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no patient stopped the study because of loss of diabetes control during tesamorelin treatment.
In plain wordsIn adults with type 2 diabetes, no one stopped the study because their diabetes control worsened.
Peptide
Tesamorelin
Outcome
No significant changeDiscontinuation due to loss of diabetes control
Study
n = 53
Outcome group
Adverse events · Metabolic and weight
Studied dose
1 mg and 2 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
No patient discontinued the study due to loss of diabetes control.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783808
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, total cholesterol decreased from baseline to week 12 with tesamorelin 2 mg, compared with placebo.
In plain wordsIn adults with type 2 diabetes, tesamorelin 2 mg lowered total cholesterol more than placebo did.
Peptide
Tesamorelin
Outcome
DecreaseTotal cholesterol change from baseline to week 12
Study
n: not reported in source
Comparator
Placebo
Outcome group
Lipids · Cardiovascular
Studied dose
2 mg · 12 weeksAs given in this study (human).
Measurements
Total cholesterol change
−0.3 mmol/L
tesamorelin 2 mg
Source sentences
Summary
Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783806
08HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, non-HDL cholesterol decreased from baseline to week 12 with tesamorelin 2 mg, compared with placebo.
In plain wordsIn adults with type 2 diabetes, tesamorelin 2 mg lowered non-HDL cholesterol more than placebo did.
Peptide
Tesamorelin
Outcome
DecreaseNon-HDL cholesterol change from baseline to week 12
Study
n: not reported in source
Comparator
Placebo
Outcome group
Lipids · Cardiovascular
Studied dose
2 mg · 12 weeksAs given in this study (human).
Measurements
Non-HDL cholesterol change
−0.3 mmol/L
tesamorelin 2 mg
Source sentences
Summary
Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes.
Summary · context
Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Show in the study text Report a problemFND-2861783807

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT01264497

Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes

Theratechnologiesn = 55Feb 2002 to Nov 2002

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 21 Dec 2010

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
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:13 UTC
First added · source update from Europe PMC

Subjects

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