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First clinical trial performed in Type 2 diabetes patients
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Covington P, Christopher R, Davenport M et al. Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple dose study in adult patients with Type 2 diabetes. Clin. Ther. 30(3), 499-512 •• First clinical trial performed in Type 2 diabetes patients.
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Demonstrates the pharmacokinetics and pharmacodynamics of alogliptin
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Christopher R, Covington P, Davenport M et al. Pharmacokinetics, pharmacodynamics, and tolerability of single increasing doses of the dipeptidyl peptidase-4 inhibitor alogliptin in healthy male subjects. Clin. Ther. 30(3), 513-527 (2008). •• Demonstrates the pharmacokinetics and pharmacodynamics of alogliptin.
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77953459096
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Disposition of the dipeptidyl peptidase-4 inhibitor [14C] alogliptin benzoate ([14C]SYR-322) after oral administration to healthy male subjects
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Demonstrates the metabolism of alogliptin
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Karim A, Bridson WE, Fleck P, Schuster S, Zhang W, Mekki Q. Disposition of the dipeptidyl peptidase-4 inhibitor [14C] alogliptin benzoate ([14C]SYR-322) after oral administration to healthy male subjects. AAPS J. 9(Suppl. 2), (2007). •• Demonstrates the metabolism of alogliptin.
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Karim, A.1
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16
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70549089727
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Effect of fluconazole, ketoconazole, and gemfibrozil on the pharmacokinetics of alogliptin benzoate (SYR-322) in healthy subjects
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Presented at: 36th Meeting of the American College of Clinical Pharmacology. San Francisco, CA, USA, 9-11 September 2007 Abstract 105
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Karim A, Fleck P, Harris S, Schuster J, Zhang W, Mekki Q. Effect of fluconazole, ketoconazole, and gemfibrozil on the pharmacokinetics of alogliptin benzoate (SYR-322) in healthy subjects. Presented at: 36th Meeting of the American College of Clinical Pharmacology. San Francisco, CA, USA, 9-11 September 2007. J. Clin. Pharmacol. 47(9), 1207, (2007) (Abstract 105).
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for the Alogliptin Study 008 Group
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Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q, for the Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with Type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int. J. Clin. Pract. 36(1), 46-55 (2009).
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18
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58149142110
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Efficacy and safety of alogliptin added to pioglitazone therapy in patients with Type 2 diabetes
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Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6 June-10 June 2008. Abstract 478-P
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Pratley R, Reusch J, Fleck P, Wilson C, Mekki Q. Efficacy and safety of alogliptin added to pioglitazone therapy in patients with Type 2 diabetes. Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6 June-10 June 2008. Diabetes 57(Suppl. 1), (2008) (Abstract 478-P).
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58149335320
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Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with Type 2 diabetes inadequately controlled by glyburide monotherapy
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on behalf of the Alogliptin Study 007 Group
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Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; on behalf of the Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with Type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes. Obes. Metab. 11, 167-176 (2009).
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20
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58149171060
-
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with Type 2 diabetes and inadequate glycemic control
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on behalf of the Alogliptin Study 010 Group Demonstrates that alogliptin is efficacious as a monotherapy in a Phase III study
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DeFronzo RA, Fleck PR, Wilson CA, Mekki Q, on behalf of the Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with Type 2 diabetes and inadequate glycemic control. Diabetes Care 31(12), 2315-2317 (2008). • Demonstrates that alogliptin is efficacious as a monotherapy in a Phase III study.
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DeFronzo, R.A.1
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21
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67649377847
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Alogliptin added to insulin therapy in patients with Type 2 diabetes reduces HbA1c without increasing weight gain or hypoglycemia
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Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6-10 June 2008. Abstract 444-P
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Rosenstock J, Rendell M, Gross JL, Fleck P, Wilson C, Mekki Q. Alogliptin added to insulin therapy in patients with Type 2 diabetes reduces HbA1c without increasing weight gain or hypoglycemia. Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6-10 June 2008. Diabetes 57(Suppl. 1), (2008) (Abstract 444-P).
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Single-dose pharmacokinetics of the dipeptidyl peptidase-4 inhibitor alogliptin in subjects with renal impairment
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Effects of age, race, and gender on the pharmacokinetics and pharmacodynamics of alogliptin, a novel and highly selective dipeptidyl peptidase-4 inhibitor, in healthy subjects
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Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008 (Abstract PI-14). Demonstrated that that are no clinically relevant differences in the effect of alogliptin on pharmacokinetics and pharmacodynamics as a result of age, race, or gender.
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Karim A, Fleck P, Harrell RE Jr et al. Effects of age, race, and gender on the pharmacokinetics and pharmacodynamics of alogliptin, a novel and highly selective dipeptidyl peptidase-4 inhibitor, in healthy subjects. Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008. Clin. Pharmacol. Ther. 83(Suppl. 1), S13 (2008) (Abstract PI-14). •• Demonstrated that that are no clinically relevant differences in the effect of alogliptin on pharmacokinetics and pharmacodynamics as a result of age, race, or gender.
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70549104588
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Effect of food on absorption and pharmacokinetics of antidiabetic drug, alogliptin, in healthy subjects
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Presented at: American Association of Pharmaceutical Scientists Annual Meeting and Exposition. Atlanta, GA, USA, 17-19 November 2008 Abstract 1761
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Karim A, Kissling J, Munsaka M. Effect of food on absorption and pharmacokinetics of antidiabetic drug, alogliptin, in healthy subjects. Presented at: American Association of Pharmaceutical Scientists Annual Meeting and Exposition. Atlanta, GA, USA, 17-19 November 2008. AAPS J. 10(Suppl. 2), (2008) (Abstract 1761).
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67649340196
-
No pharmacokinetic interaction between alogliptin benzoate (SYR-322) and pioglitazone hydrochloride
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Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007 Abstract 2117-PO
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Karim A, Fleck P, Joseph M et al. No pharmacokinetic interaction between alogliptin benzoate (SYR-322) and pioglitazone hydrochloride. Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007. Diabetes 56(Suppl. 1), (2007) (Abstract 2117-PO).
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Karim, A.1
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67649320615
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Lack of effect of multiple doses of alogliptin benzoate (SYR-322) on the pharmacokinetics of glyburide in healthy subjects
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Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007 Abstract 2135-PO
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Fleck P, Karim A, Harris S et al. Lack of effect of multiple doses of alogliptin benzoate (SYR-322) on the pharmacokinetics of glyburide in healthy subjects. Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007. Diabetes 56(Suppl. 1), (2007) (Abstract 2135-PO).
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Fleck, P.1
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41649085328
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Lack of pharmacokinetic interaction between alogliptin benzoate (SYR-322) and metformin in healthy subjects
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Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007 Abstract 2136-PO
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Covington P, Christopher R, Davenport M et al. Lack of pharmacokinetic interaction between alogliptin benzoate (SYR-322) and metformin in healthy subjects. Presented at: American Diabetes Association 67th Scientific Sessions. Chicago, IL, USA, 22-26 June 2007. Diabetes 56(Suppl. 1), (2007) (Abstract 2136-PO).
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Covington, P.1
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70549088886
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Effects of alogliptin on the pharmacokinetics and pharmacodynamics of norethindrone and ethinyl estradiol (Ortho-Novum® 1/35) in healthy adult female subjects
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Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008 Abstract PI-16
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Karim A, Copa A, Fleck P, Helland J, Munsaka M, Mekki Q. Effects of alogliptin on the pharmacokinetics and pharmacodynamics of norethindrone and ethinyl estradiol (Ortho-Novum® 1/35) in healthy adult female subjects. Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008. Clin. Pharmacol. Ther. 83(Suppl. 1), S14, (2008) (Abstract PI-16).
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36
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70549086586
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Lack of effect of cyclosporine on the single-dose pharmacokinetics of alogliptin, a novel dipeptidyl peptidase-4 inhibitor, in healthy male subjects
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Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008 Abstract PI-15
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Karim A, Chiselko P, Fleck P, Harris S, Munsaka M, Mekki Q. Lack of effect of cyclosporine on the single-dose pharmacokinetics of alogliptin, a novel dipeptidyl peptidase-4 inhibitor, in healthy male subjects. Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008. Clin. Pharmacol. Ther. 83(Suppl. 1), S13, (2008) (Abstract PI-15).
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37
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70549092751
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Lack of pharmacokinetic interaction between multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin and digoxin in healthy subjects
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Karim A, Fleck P, Harris S, Weiss M, Zhang W, Mekki Q. Lack of pharmacokinetic interaction between multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin and digoxin in healthy subjects. Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008. Clin. Pharmacol. Ther. 83(Suppl. 1), S12 (2008) (Abstract PI-13).
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Presented at: 36th Meeting of the American College of Clinical Pharmacology. San Francisco, CA, USA, 9-11 September 2007 Abstract 106
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Assessment of drug interaction between alogliptin, a highly selective dipeptidyl peptidase-4 inhibitor, and atorvastatin in healthy subjects
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Karim A, Fleck P, Harris S, Munsaka M, Weiss M, Mekki Q. Assessment of drug interaction between alogliptin, a highly selective dipeptidyl peptidase-4 inhibitor, and atorvastatin in healthy subjects. Presented at: American Society for Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, USA, 2-5 April 2008. Clin. Pharmacol. Ther. 83(Suppl. 1), S14 (2008) (Abstract PI-17).
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Efficacy and safety of alogliptin monotherapy over 12 weeks in patients with Type 2 diabetes
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Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6-10 June 2008 (Abstract 479-P). Demonstrates that alogliptin is efficacious and well tolerated in patients with Type 2 diabetes
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Fleck P, Christopher R, Covington P, Wilson C, Mekki Q. Efficacy and safety of alogliptin monotherapy over 12 weeks in patients with Type 2 diabetes. Presented at: American Diabetes Association 68th Scientific Sessions. San Francisco, CA, USA, 6-10 June 2008. Diabetes 57(Suppl. 1), (2008) (Abstract 479-P). • Demonstrates that alogliptin is efficacious and well tolerated in patients with Type 2 diabetes.
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