Tags

Type your tag names separated by a space and hit enter

Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes.
Curr Med Res Opin. 2007 Jun; 23(6):1329-39.CM

Abstract

OBJECTIVE

Sitagliptin, an oral, potent, and selective dipeptidyl peptidase-4 (DPP-4) inhibitor was evaluated as once-daily monotherapy in a 12-week randomized, double-blind, placebo-controlled, parallel group, dose-ranging study. Additionally, the glycemic response to sitagliptin 100 mg daily was evaluated as a once-daily (100 mg once-daily) or twice-daily (50 mg twice-daily) dosing regimen.

RESEARCH DESIGN AND METHODS

In a multinational, double-blind, randomized, placebo-controlled, parallel-group, dose-range finding study, 555 patients, 23-74 years of age, with HbA(1c) of 6.5-10.0% were randomized to one of five treatment groups: placebo, sitagliptin 25, 50 or 100 mg once-daily, or sitagliptin 50 mg twice-daily for 12 weeks. The efficacy analysis was based on the all-patients-treated population using an ANCOVA model.

RESULTS

Mean baseline HbA(1c) ranged from 7.6 to 7.8% across treatment groups, with 29% of all patients with values < or =7%. After 12 weeks, treatment with all doses of sitagliptin significantly (p < 0.05) reduced HbA(1c) by -0.39 to -0.56% and fasting plasma glucose by -11.0 to -17.2 mg/dL relative to placebo, with the greatest reduction observed in the 100-mg once-daily group. Mean daily glucose was significantly (p < 0.05) reduced by -14.0 to -22.6 mg/dL with all doses of sitagliptin relative to placebo. HOMA-beta was significantly (p < 0.05) increased by 11.3-15.2 with all sitagliptin doses relative to placebo. QUICKI and HOMA-IR were not significantly changed with sitagliptin treatment. There were no significant differences observed between the sitagliptin 100 mg once-daily and 50 mg twice-daily groups for any parameter. For sitagliptin, the incidence of adverse events of hypoglycemia was low, with one event in each of the 25- and 50-mg once-daily and 50-mg twice-daily treatment groups and two events in the 100 mg once-daily treatment group. There was no mean change in body weight with sitagliptin relative to placebo. Study duration may be a limitation because the extent of the glycemic response and the safety and tolerability may not have been fully elucidated in this 12-week study.

CONCLUSION

Sitagliptin monotherapy improved indices of glycemic control compared to placebo and was generally well-tolerated in patients with type 2 diabetes. The glycemic response to treatment with sitagliptin 100 mg/day was similar between the sitagliptin 100-mg once-daily and 50-mg twice-daily dose regimens.

Authors+Show Affiliations

GWT-Technical University, Dresden, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17559733

Citation

Hanefeld, Markolf, et al. "Once-daily Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, for the Treatment of Patients With Type 2 Diabetes." Current Medical Research and Opinion, vol. 23, no. 6, 2007, pp. 1329-39.
Hanefeld M, Herman GA, Wu M, et al. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007;23(6):1329-39.
Hanefeld, M., Herman, G. A., Wu, M., Mickel, C., Sanchez, M., & Stein, P. P. (2007). Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Current Medical Research and Opinion, 23(6), 1329-39.
Hanefeld M, et al. Once-daily Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, for the Treatment of Patients With Type 2 Diabetes. Curr Med Res Opin. 2007;23(6):1329-39. PubMed PMID: 17559733.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. AU - Hanefeld,Markolf, AU - Herman,Gary A, AU - Wu,Mei, AU - Mickel,Carolyn, AU - Sanchez,Matilde, AU - Stein,Peter P, AU - ,, Y1 - 2007/04/30/ PY - 2007/6/15/pubmed PY - 2008/7/10/medline PY - 2007/6/15/entrez SP - 1329 EP - 39 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 23 IS - 6 N2 - OBJECTIVE: Sitagliptin, an oral, potent, and selective dipeptidyl peptidase-4 (DPP-4) inhibitor was evaluated as once-daily monotherapy in a 12-week randomized, double-blind, placebo-controlled, parallel group, dose-ranging study. Additionally, the glycemic response to sitagliptin 100 mg daily was evaluated as a once-daily (100 mg once-daily) or twice-daily (50 mg twice-daily) dosing regimen. RESEARCH DESIGN AND METHODS: In a multinational, double-blind, randomized, placebo-controlled, parallel-group, dose-range finding study, 555 patients, 23-74 years of age, with HbA(1c) of 6.5-10.0% were randomized to one of five treatment groups: placebo, sitagliptin 25, 50 or 100 mg once-daily, or sitagliptin 50 mg twice-daily for 12 weeks. The efficacy analysis was based on the all-patients-treated population using an ANCOVA model. RESULTS: Mean baseline HbA(1c) ranged from 7.6 to 7.8% across treatment groups, with 29% of all patients with values < or =7%. After 12 weeks, treatment with all doses of sitagliptin significantly (p < 0.05) reduced HbA(1c) by -0.39 to -0.56% and fasting plasma glucose by -11.0 to -17.2 mg/dL relative to placebo, with the greatest reduction observed in the 100-mg once-daily group. Mean daily glucose was significantly (p < 0.05) reduced by -14.0 to -22.6 mg/dL with all doses of sitagliptin relative to placebo. HOMA-beta was significantly (p < 0.05) increased by 11.3-15.2 with all sitagliptin doses relative to placebo. QUICKI and HOMA-IR were not significantly changed with sitagliptin treatment. There were no significant differences observed between the sitagliptin 100 mg once-daily and 50 mg twice-daily groups for any parameter. For sitagliptin, the incidence of adverse events of hypoglycemia was low, with one event in each of the 25- and 50-mg once-daily and 50-mg twice-daily treatment groups and two events in the 100 mg once-daily treatment group. There was no mean change in body weight with sitagliptin relative to placebo. Study duration may be a limitation because the extent of the glycemic response and the safety and tolerability may not have been fully elucidated in this 12-week study. CONCLUSION: Sitagliptin monotherapy improved indices of glycemic control compared to placebo and was generally well-tolerated in patients with type 2 diabetes. The glycemic response to treatment with sitagliptin 100 mg/day was similar between the sitagliptin 100-mg once-daily and 50-mg twice-daily dose regimens. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17559733/Once_daily_sitagliptin_a_dipeptidyl_peptidase_4_inhibitor_for_the_treatment_of_patients_with_type_2_diabetes_ L2 - https://www.tandfonline.com/doi/full/10.1185/030079907X188152 DB - PRIME DP - Unbound Medicine ER -