Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled study with an open-label, long-term extension

Diabetes, Obesity and Metabolism

Volumn 16, Issue 5, 2014, Pages 418-425

  Kadowaki, T ^a   Kondo, Kazuoki ^b  

^a UNIVERSITY OF TOKYO   (Japan)

^b MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

Author keywords

DPP 4 inhibitor; Glimepiride; HbA1c; Japanese; Teneligliptin; Type 2 diabetes mellitus

Indexed keywords

GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; PLACEBO; TENELIGLIPTIN; 3-(4-(4-(3-METHYL-1-PHENYL-1H-PYRAZOL-5-YL)PIPERAZIN-1-YL)PYRROLIDIN-2-YLCARBONYL)THIAZOLIDINE; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; PYRAZOLE DERIVATIVE; SULFONYLUREA DERIVATIVE; THIAZOLIDINE DERIVATIVE;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DIABETIC PATIENT; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INCIDENCE; JAPANESE; MAJOR CLINICAL STUDY; MONOTHERAPY; MORNING DOSAGE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SIDE EFFECT; TREATMENT DURATION; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DIET RESTRICTION; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; JAPAN; MALE; METABOLISM; MIDDLE AGED; POSTPRANDIAL STATE; TREATMENT OUTCOME;

ADULT; AGED; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FASTING; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; JAPAN; MALE; MIDDLE AGED; POSTPRANDIAL PERIOD; PYRAZOLES; SULFONYLUREA COMPOUNDS; THIAZOLIDINES; TREATMENT OUTCOME;

EID: 84898833197     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12235     Document Type: Article

References (18)

1. Kreymann B, Williams G, Ghatei MA, Bloom SR. Glucagon-like peptide-1 7-36: a physiological incretin in man. Lancet 1987; 2: 1300-1304.
2. Edwards CM, Todd JF, Mahmoudi M et al. Glucagon-like peptide 1 has a physiological role in the control of postprandial glucose in humans: studies with the antagonist exendin 9-39. Diabetes 1999; 48: 86-93.
3. Deacon CF, Nauck MA, Toft-Nielsen M et al. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes 1995; 44: 1126-1131.
4. Holst JJ, Deacon CF. Inhibition of the activity of dipeptidyl-peptidase IV as a treatment for type 2 diabetes. Diabetes 1998; 47: 1663-1670.
5. Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab 2012; 14: 1040-1046.
6. Kadowaki T, Kondo K. Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab 2013; DOI: 10.1111/dom.12092.
7. Neville SE, Boye KS, Montgomery WS, Iwamoto K, Okamura M, Hayes RP. Diabetes in Japan: a review of disease burden and approaches to treatment. Diabetes Metab Res Rev 2009; 25: 705-716.
8. Idris I, Donnelly R. Dipeptidyl peptidase-IV inhibitors: a major new class of oral antidiabetic drug. Diabetes Obes Metab 2007; 9: 153-165.
9. Del Prato S, Pulizzi N. The place of sulfonylureas in the therapy for type 2 diabetes mellitus. Metabolism 2006; 55: S20-S27.
10. Zhang CL, Katoh M, Shibasaki T et al. The cAMP sensor Epac2 is a direct target of antidiabetic sulfonylurea drugs. Science 2009; 325: 607-610.
11. Tajima N, Kadowaki T, Odawara M et al. Addition of sitagliptin to ongoing glimepiride therapy in Japanese patients with type 2 diabetes over 52weeks leads to improved glycemic control. Diabetol Int 2011; 2: 32-44.
12. Kikuchi M, Haneda M, Koya D et al. Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract 2010; 89: 216-223.
13. The Japan Diabetes Society. Report of the Committee Concerning Proper Use of Incretin (GLP-1 receptor agonist and DPP-4 inhibitor). 2011. Available from URL: http://www.jds.or.jp/uploads/photos/797.pdf (in Japanese). Accessed 1 February 2013.
14. Tominaga M, Kobayashi I, Kuwa K et al. HbA1c value of JDS Lot 2 determined by NGSP. J Jpn Diabetes Soc 2002; 45: 385-388(in Japanese).
15. Mukai E, Fujimoto S, Inagaki N. Severe hypoglycemia by combination therapy with dipeptidyl peptidase-4 (DPP-4) inhibitors and sulfonylureas. Nihon Rinsho 2011; 69: 907-911(In Japanese).
16. Gallwitz B, Häring HU. Future perspectives for insulinotropic agents in the treatment of type 2 diabetes-DPP-4 inhibitors and sulphonylureas. Diabetes Obes Metab 2010; 12: 1-11.
17. Mitsubishi Tanabe Pharma Corp. Tenelia® tablets 20mg Package Insert 2012.
18. de Heer J, Holst JJ. Sulfonylurea compounds uncouple the glucose dependence of the insulinotropic effect of glucagon-like peptide 1. Diabetes 2007; 56: 438-443.