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Byetta (Exenatide Injection) - Summary



BYETTA (exenatide) is a synthetic peptide that was originally identified in the lizard Heloderma suspectum. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, alpha-glucosidase inhibitors, amylinomimetics and dipeptidyl peptidase-4 inhibitors. Exenatide is a 39-amino acid peptide amide.

Type 2 Diabetes Mellitus

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

BYETTA is not a substitute for insulin. BYETTA should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

The concurrent use of BYETTA with prandial insulin has not been studied and cannot be recommended.

Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

See all Byetta indications & dosage >>


Published Studies Related to Byetta (Exenatide Injection)

Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. [2013]
and American College of Endocrinology treatment algorithm... CONCLUSION: Significantly greater improvements in HbA1c and FBG levels were

Exenatide and the treatment of patients with Parkinson's disease. [2013]

Effects of HbA1c and weight reduction on blood pressure in patients with type 2 diabetes mellitus treated with exenatide*. [2012]
with either exenatide twice daily (BID) or once weekly (QW)... CONCLUSION: Although the mechanism of BP-lowering effect of exenatide is not

Investigation of the haemodynamic effects of exenatide in healthy male subjects. [2012]
male volunteers... CONCLUSIONS: Exenatide has significant haemodynamic effects in healthy

Exenatide as a Weight-Loss Therapy in Extreme Pediatric Obesity: A Randomized, Controlled Pilot Study. [2011.11.10]
The objective of this pilot study was to evaluate the effects of exenatide on BMI (primary endpoint) and cardiometabolic risk factors in nondiabetic youth with extreme obesity. Twelve children and adolescents (age 9-16 years old) with extreme obesity (BMI >/=1.2 times the 95th percentile or BMI >/=35 kg/m(2)) were enrolled in a 6-month, randomized, open-label, crossover, clinical trial consisting of two, 3-month phases: (i) a control phase of lifestyle modification and (ii) a drug phase of lifestyle modification plus exenatide...

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Clinical Trials Related to Byetta (Exenatide Injection)

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females [Completed]

Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease [Terminated]

Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function [Completed]
Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In this proposal we will examine the effect of combination therapy with pioglitazone plus exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug separately. Assessment of beta cell function will be performed by measuring the maximal insulin secretory capacity using a maximal hyperglycemic stimulus combined with an intravenous arginine stimulus.

A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes [Completed]
As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) [Completed]
This is a Pharmacokinetic (PK) sub-study to determine the relative bioavailability of exenatide when administered using the once weekly dual chambered pen and the once weekly single dose tray.

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Reports of Suspected Byetta (Exenatide Injection) Side Effects

Pancreatitis (282)Weight Decreased (157)Nausea (152)OFF Label USE (138)Pancreatitis Acute (112)Blood Glucose Increased (109)Renal Failure (106)Vomiting (100)Pancreatic Carcinoma (96)Diarrhoea (49)more >>


Based on a total of 7 ratings/reviews, Byetta has an overall score of 7.86. The effectiveness score is 8.86 and the side effect score is 7.43. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Byetta review by 42 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   diabetes
Dosage & duration:   10mcg (dosage frequency: 2x daily) for the period of 2 years
Other conditions:   narcolepsy
Other drugs taken:   provigil
Reported Results
Benefits:   helped to stay awake, without the side effects that I had when I used to take dexedrine, like jittery, agitation, dry mouth
Side effects:   There really weren't any side effects like those described above from dexedrine.
Comments:   100-150 mg a day, 100mg taken in the am, 50mg in pm (if needed) to help with daytime sleepiness, caused by narcolepsy. I usually do not take the afternoon dose unless I feel really tired and nervous about driving.


Byetta review by 51 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Diabetic
Dosage & duration:   10 mcg (dosage frequency: twice daily) for the period of 4 years
Other conditions:   blockage & allergies
Other drugs taken:   metformin, allegra, lipator, tricor
Reported Results
Benefits:   This slows the sugar going into my system so that my body can use most of my own insulin to process the sugar. It is to be taken along with the metformin. It has helped control my blood sugar very well.
Side effects:   It can sometimes cause nausea. At the start of treatment it was bad but now it only happens if I miss a dose then the next one will cause nausea. The first couple of months I saw a very slight drop in weight but I am not sure if the Byetta caused this.
Comments:   I take a shot before my first meal and last meal each day. It is a very easy shot to give to myself but it is easy to forget if I eat out or if I am traveling.


Byetta review by 56 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   obesity and diabetes
Dosage & duration:   5mcg and 10mcg (dosage frequency: 2 times per day) for the period of 2 years
Other conditions:   none
Other drugs taken:   luvox, norvasc, metformin
Reported Results
Benefits:   I initially had severe cramping and nausea, but I continued under doctor's orders, I only lost about 20 pounds, tops. I now have a larger host of problems I believe were started with this medication. I have not used in 3 years.
Side effects:   Severe cramping, headaches, incredible nausea, muscle cramps, vomiting blood (not once but on 2 occasions due to doctor's orders). I now am facing something wrong with my digestive tract and no doctor has been able to figure out what is wrong. Since this is the area where the medication was injected, and only there, I believe that the byetta is the perfect suspect. Now, if I could only find a doctor that will listen to me. The count is 5 and still increasing. Recently, I lost 4 pounds in 3 days!!!! This is not normal!
Comments:   I was to inject the said amount into the abdominal (below the waist, above the pelvic bone) before breakfast and lunch. The amount was changed when the medical professional I was having treat me decided to increase the dosage, and with terrible results (I was vomiting blood and could not eat or even drink water - I couldn't even stand the smell of food). I wish I had never heard of Byetta!!!!!!

See all Byetta reviews / ratings >>

Page last updated: 2014-11-30

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