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Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus.

Kadowaki T, Kondo K - J Diabetes Investig (2013)

Bottom Line: Patients in the teneligliptin group showed significantly greater reductions in HbA1c compared with the placebo group at week 12 (P < 0.001).The change in fasting plasma glucose from baseline to week 12 was greater in the teneligliptin group than in the placebo group (P < 0.001).The blood glucose lowering effects of teneligliptin were sustained throughout the 40-week open-label period.

View Article: PubMed Central - PubMed

Affiliation: Department of Metabolic Diseases Graduate School of Medicine The University of Tokyo Tokyo Japan.

ABSTRACT

Aim: To confirm the efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy.

Materials and methods: In an initial 12-week, double-blind, placebo controlled, parallel-group study, patients (n = 204) were randomized to teneligliptin 20 mg or placebo once daily added to their stable pioglitazone therapy. This was followed by a 40-week, open-label period during which all patients received teneligliptin once daily. The primary end-point was the change in hemoglobin A1c (HbA1c) from baseline to week 12.

Results: Patients in the teneligliptin group showed significantly greater reductions in HbA1c compared with the placebo group at week 12 (P < 0.001). The changes in HbA1c from baseline to week 12 were -0.9 ± 0.0% (least-squares mean ± standard error) in the teneligliptin group and -0.2 ± 0.0% in the placebo group. The change in fasting plasma glucose from baseline to week 12 was greater in the teneligliptin group than in the placebo group (P < 0.001). The blood glucose lowering effects of teneligliptin were sustained throughout the 40-week open-label period. Adverse events and adverse drug reactions occurred slightly more frequently in the teneligliptin group than in the placebo group, although the incidence of hypoglycemia was low. Bodyweight was unchanged in the double-blind period, but was slightly increased in the open-label period.

Conclusions: Add-on therapy with teneligliptin was effective and generally well tolerated throughout the study period in Japanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy. This trial was registered with ClinicalTrials.gov (no. NCT01026194).

No MeSH data available.


Related in: MedlinePlus

Flow diagram of patients participating in the trial. P/T, patients who had taken a placebo during the double‐blind period and then received teneligliptin 20 mg in the open‐label period; T/T, patients who had taken teneligliptin 20 mg during the double‐blind period and then continued medication with the same dose in the open‐label period.
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jdi12092-fig-0001: Flow diagram of patients participating in the trial. P/T, patients who had taken a placebo during the double‐blind period and then received teneligliptin 20 mg in the open‐label period; T/T, patients who had taken teneligliptin 20 mg during the double‐blind period and then continued medication with the same dose in the open‐label period.

Mentions: The disposition of patients is summarized in Figure 1. Of the 246 patients who started the run‐in period; 204 patients were randomized to either teneligliptin (n = 103) or a placebo (n = 101), and entered the double‐blind period. Of these, 196 patients (98 in each group) entered the open‐label period, and 179 patients subsequently completed the study (91 in the P/T group and 88 in the T/T group). Patient characteristics are listed in Table 1, and were generally similar in the two groups. The mean baseline values for HbA1c, duration of diabetes, body mass index, and bodyweight for all patients were 8.0%, 7.4 years, 25.9 kg/m2 and 68.8 kg, respectively.


Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus.

Kadowaki T, Kondo K - J Diabetes Investig (2013)

Flow diagram of patients participating in the trial. P/T, patients who had taken a placebo during the double‐blind period and then received teneligliptin 20 mg in the open‐label period; T/T, patients who had taken teneligliptin 20 mg during the double‐blind period and then continued medication with the same dose in the open‐label period.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4020253&req=5

jdi12092-fig-0001: Flow diagram of patients participating in the trial. P/T, patients who had taken a placebo during the double‐blind period and then received teneligliptin 20 mg in the open‐label period; T/T, patients who had taken teneligliptin 20 mg during the double‐blind period and then continued medication with the same dose in the open‐label period.
Mentions: The disposition of patients is summarized in Figure 1. Of the 246 patients who started the run‐in period; 204 patients were randomized to either teneligliptin (n = 103) or a placebo (n = 101), and entered the double‐blind period. Of these, 196 patients (98 in each group) entered the open‐label period, and 179 patients subsequently completed the study (91 in the P/T group and 88 in the T/T group). Patient characteristics are listed in Table 1, and were generally similar in the two groups. The mean baseline values for HbA1c, duration of diabetes, body mass index, and bodyweight for all patients were 8.0%, 7.4 years, 25.9 kg/m2 and 68.8 kg, respectively.

Bottom Line: Patients in the teneligliptin group showed significantly greater reductions in HbA1c compared with the placebo group at week 12 (P < 0.001).The change in fasting plasma glucose from baseline to week 12 was greater in the teneligliptin group than in the placebo group (P < 0.001).The blood glucose lowering effects of teneligliptin were sustained throughout the 40-week open-label period.

View Article: PubMed Central - PubMed

Affiliation: Department of Metabolic Diseases Graduate School of Medicine The University of Tokyo Tokyo Japan.

ABSTRACT

Aim: To confirm the efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy.

Materials and methods: In an initial 12-week, double-blind, placebo controlled, parallel-group study, patients (n = 204) were randomized to teneligliptin 20 mg or placebo once daily added to their stable pioglitazone therapy. This was followed by a 40-week, open-label period during which all patients received teneligliptin once daily. The primary end-point was the change in hemoglobin A1c (HbA1c) from baseline to week 12.

Results: Patients in the teneligliptin group showed significantly greater reductions in HbA1c compared with the placebo group at week 12 (P < 0.001). The changes in HbA1c from baseline to week 12 were -0.9 ± 0.0% (least-squares mean ± standard error) in the teneligliptin group and -0.2 ± 0.0% in the placebo group. The change in fasting plasma glucose from baseline to week 12 was greater in the teneligliptin group than in the placebo group (P < 0.001). The blood glucose lowering effects of teneligliptin were sustained throughout the 40-week open-label period. Adverse events and adverse drug reactions occurred slightly more frequently in the teneligliptin group than in the placebo group, although the incidence of hypoglycemia was low. Bodyweight was unchanged in the double-blind period, but was slightly increased in the open-label period.

Conclusions: Add-on therapy with teneligliptin was effective and generally well tolerated throughout the study period in Japanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy. This trial was registered with ClinicalTrials.gov (no. NCT01026194).

No MeSH data available.


Related in: MedlinePlus