Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study.

Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A

Diabetes, obesity & metabolism1 Dec 2009Cited by 117 (Europe PMC)

PMID19930005PMCIDPMC2810445DOI10.1111/j.1463-1326.2009.01154.xPepBankPUB-19930005

Summary

AimThe Helping Evaluate Exenatide in overweight patients with diabetes compared with Long-Acting insulin (HEELA) study was designed to examine whether the glucagon-like peptide-1 (GLP-1) receptor agonist, exenatide, could improve HbA1c (< or =7.4%) with minimal weight gain (< or =1 kg) compared with insulin glargine.MethodsPatients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.ResultsThe study population had baseline mean (s.d.) age of 56.5 (9.1) years and BMI of 34.1 (5.3) kg/m(2), and 58.5% of patients were taking two OADs. Mean baseline HbA1c was 8.65 (0.68)% in the exenatide group and 8.48 (0.66)% in the insulin glargine group. The proportions of patients achieving the composite endpoint of HbA1c < or =7.4% with weight gain < or =1 kg were 53.4% for the exenatide group and 19.8% for the insulin glargine group (p < 0.001 for exenatide vs. insulin glargine). Exenatide and insulin glargine did not demonstrate a significant difference in HbA1c improvements [least square (LS) mean [s.e.m.]: -1.25 [0.09]% and -1.26 [0.09]% respectively; p = 0.924], but had divergent effects on body weight (-2.73 [0.31] vs. +2.98 [0.31] kg respectively, p < 0.001) after 26 weeks. There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.ConclusionsAdditional treatment with exenatide resulted in significantly more overweight and obese patients with an elevated cardiovascular risk and type 2 diabetes achieving better glycaemic control with minimal weight gain compared with insulin glargine.

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 type 2 diabetes, more exenatide recipients achieved HbA1c <=7.4% with weight gain <=1 kg than insulin glargine recipients.
In plain wordsIn type 2 diabetes, more patients met the combined glucose and weight target with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseComposite glycemic and weight endpoint
Study
n = 235
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c <=7.4% with weight gain <=1 kg
53.4%
exenatide group
Patients achieving HbA1c <=7.4% with weight gain <=1 kg
19.8%
insulin glargine group
Source sentences
Summary
The proportions of patients achieving the composite endpoint of HbA1c < or =7.4% with weight gain < or =1 kg were 53.4% for the exenatide group and 19.8% for the insulin glargine group (p < 0.001 for exenatide vs. insulin glargine).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000501
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, HbA1c improvement did not significantly differ between exenatide and insulin glargine.
In plain wordsIn type 2 diabetes, HbA1c improvement did not significantly differ between exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c improvement
Study
n = 235
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
HbA1c change (LS mean)
−1.25%
exenatide group (s.e.m. 0.09)
HbA1c change (LS mean)
−1.26%
insulin glargine group (s.e.m. 0.09)
Source sentences
Summary
Exenatide and insulin glargine did not demonstrate a significant difference in HbA1c improvements [least square (LS) mean [s.e.m.]: -1.25 [0.09]% and -1.26 [0.09]% respectively; p = 0.924], but had divergent effects on body weight (-2.73 [0.31] vs. +2.98 [0.31] kg respectively, p < 0.001) after 26 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000502
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced body weight while insulin glargine increased it.
In plain wordsIn type 2 diabetes, patients lost weight with exenatide and gained weight with insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight change
Study
n = 235
Comparator
Insulin glargine
Outcome group
Body weight · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Body weight change (LS mean)
−2.73 kg
exenatide group (s.e.m. 0.31)
Body weight change (LS mean)
2.98 kg
insulin glargine group (s.e.m. 0.31)
Source sentences
Summary
Exenatide and insulin glargine did not demonstrate a significant difference in HbA1c improvements [least square (LS) mean [s.e.m.]: -1.25 [0.09]% and -1.26 [0.09]% respectively; p = 0.924], but had divergent effects on body weight (-2.73 [0.31] vs. +2.98 [0.31] kg respectively, p < 0.001) after 26 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000503
04HumanRandomized controlled trialSafety outcome
In type 2 diabetes, exenatide caused more treatment-related adverse events than insulin glargine.
In plain wordsIn type 2 diabetes, treatment-related adverse events were more common with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseTreatment-related adverse events
Study
n = 235
Comparator
Insulin glargine
Outcome group
Adverse events · Whole body
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000504
05HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nocturnal hypoglycaemia was less frequent with exenatide than insulin glargine.
In plain wordsIn type 2 diabetes, nighttime low blood sugar was less common with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNocturnal hypoglycaemia
Study
n = 235
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000505
06HumanRandomized controlled trialSafety outcome
In type 2 diabetes, overall hypoglycaemia did not differ between exenatide and insulin glargine.
In plain wordsIn type 2 diabetes, overall low blood sugar rates did not differ between exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeOverall hypoglycaemia
Study
n = 235
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000506
07HumanRandomized controlled trialSafety outcome
In type 2 diabetes, severe hypoglycaemia did not differ between exenatide and insulin glargine.
In plain wordsIn type 2 diabetes, severe low blood sugar rates did not differ between exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSevere hypoglycaemia
Study
n = 235
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.
Show in the study text Report a problemFND-1993000507

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

CompletedPhase 3Results postedNCT00360334

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

AstraZenecan = 235Jun 2006 to Apr 2008

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 7 Apr 2015

Version history

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Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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