Effects of exenatide twice daily versus sitagliptin on 24-h glucose, glucoregulatory and hormonal measures: A randomized, double-blind, crossover study

Diabetes, Obesity and Metabolism

Volumn 13, Issue 11, 2011, Pages 982-989

  Berg, J K ^a   Shenouda, S K ^b   Heilmann, C R ^b   Gray, A L ^b   Holcombe, J H ^b  

^a Cetero Research   (United States)

^b Lilly USA   (United States)

Author keywords

Clinical trial; Diabetes mellitus; DPP IV inhibitor; GLP 1 analogue; Incretins; cell

Indexed keywords

EXENDIN 4; GLUCAGON; GLUCAGON LIKE PEPTIDE 1; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PLACEBO; SITAGLIPTIN;

ADULT; AGED; ANAPHYLAXIS; ARTICLE; CALORIC INTAKE; CELL FUNCTION; CONFUSION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; GLUCAGON BLOOD LEVEL; GLUCOSE ASSAY; GLUCOSE BLOOD LEVEL; GLUCOSE HOMEOSTASIS; GLYCEMIC CONTROL; HEADACHE; HOSPITAL PATIENT; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PANCREAS ISLET ALPHA CELL; PANCREAS ISLET BETA CELL; POSTPRANDIAL STATE; RANDOMIZED CONTROLLED TRIAL; TEST MEAL; TREATMENT DURATION; VOMITING;

EID: 80053390364     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2011.01428.x     Document Type: Article

References (24)

1. Drucker DJ. The biology of incretin hormones. Cell Metab 2006; 3: 153-165.
2. Herman GA, Stevens C, Van Dyck K et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther 2005; 78: 675-688.
3. Kolterman OG, Buse JB, Fineman MS et al. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab 2003; 88: 3082-3089.
4. Degn KB, Brock B, Juhl CB et al. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Diabetes 2004; 53: 2397-2403.
5. Edwards CM, Stanley SA, Davis R et al. Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers. Am J Physiol Endocrinol Metab 2001; 281: E155-161.
6. Kolterman OG, Kim DD, Shen L et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health Syst Pharm 2005; 62: 173-181.
7. Parkes DG, Pittner R, Jodka C, Smith P, Young A. Insulinotropic actions of exendin-4 and glucagon-like peptide-1 in vivo and in vitro. Metabolism 2001; 50: 583-589.
8. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29: 2632-2637.
9. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care 2006; 29: 2638-2643.
10. DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin 2008; 24: 2943-2952.
11. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925-926.
12. Schwartz SL, Ratner RE, Kim DD et al. Effect of exenatide on 24-hour blood glucose profile compared with placebo in patients with type 2 diabetes: a randomized, double-blind, two-arm, parallel-group, placebo-controlled, 2-week study. Clin Ther 2008; 30: 858-867.
13. Wallace TM, Levy JC, Matthews DR. Use and abuse of HOMA modeling. Diabetes Care 2004; 27: 1487-1495.
14. Grizzle JE. The two-period change-over design an its use in clinical trials. Biometrics 1965; 21: 467-480.
15. Shah P, Basu A, Basu R, Rizza R. Impact of lack of suppression of glucagon on glucose tolerance in humans. Am J Physiol Endocrinol Metab 1999; 277: E283-290.
16. Cervera A, Wajcberg E, Sriwijitkamol A et al. Mechanism of action of exenatide to reduce postprandial hyperglycemia in type 2 diabetes. Am J Physiol Endocrinol Metab 2008; 294: E846-E852.
17. Bunck MC, Diamant M, Corner A et al. One-year treatment with exenatide improves β-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care 2009; 32: 762-768.
18. DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC. Effects of exenatide plus rosiglitazone on β cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care 2010; 951-957.
19. Arnolds S, Dellweg S, Clair J et al. Further improvement in postprandial glucose control with the addition exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care 2010; 33: 1509-1515.
20. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care 2005; 28: 1282-1288.
21. Raskin P, Allen E, Hollander P et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005; 28: 260-265.
22. Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003; 26: 3080-3086.
23. Herman GA, Bergman A, Stevens C et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 Inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab 2006; 91: 4612-4619.
24. Flint A, Raben A, Ersboll AK, Holst JJ, Astrup A. The effect of physiological levels of glucagon-like peptide-1 on appetite, gastric emptying, energy and substrate metabolism in obesity. Int J Obes Relat Metab Disord 2001; 25: 781-792.