A 26-week, placebo-and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes

Kenneth E. Truitt, Ronald B Goldberg, Julio Rosenstock, Hubert S. Chou, Domenico Merante, Joseph Triscari, Antonia C. Wang

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: To examine the efficacy and general safety of rivoglitazone, a novel thiazolidinedione, as a treatment for type 2 diabetes in a dose-ranging study over a period of up to 6 months. Research design and methods: A 26-week, randomized, double-blind, double-dummy, placebo-and active comparator (pioglitazone 45mg)-controlled study designed to evaluate the efficacy and safety of once-daily rivoglitazone 1, 2, or 3mg in subjects with type 2 diabetes. The study was conducted in adults with type 2 diabetes (glycated hemoglobin [HbA1c] ≥ 7.0 and <10.5) who were either nave to prior antidiabetes drug treatment or discontinued pre-study antidiabetes medications and were switched to study medication. A total of 441 subjects were randomized, using an equal allocation schedule to one of five treatment arms, including placebo. The primary efficacy measurement was the change in HbA1c from baseline to week 26 in the intent-to-treat population (last observation carried forward), for drug treatments minus placebo (placebo-subtracted). Clinical Trial Registration: ClinicalTrials.gov Identifier NCT00143520 Results: The incidence of early discontinuations was >50, with most cases being related to a lack of efficacy (highest on placebo) or adverse experiences (highest on rivoglitazone 3mg). Rivoglitazone 1, 2, and 3mg and pioglitazone 45mg were more effective than placebo in reducing HbA1c from baseline to week 26 (placebo-subtracted change from baseline:-0.55 [p0.0034],-0.99 [p<0.0001],-1.10 [p<0.0001], and-0.59 [p0.0016], respectively). In general, all treatments were safe. The most common drug-related adverse events reported with rivoglitazone were peripheral edema and weight gain; incidences increased with dose and were higher with rivoglitazone 2 and 3mg than with pioglitazone or rivoglitazone 1mg. Conclusions: Rivoglitazone is a potent thiazolidinedione agent with demonstrated glycemic benefits over a 6-month period in subjects with type 2 diabetes. Once-daily doses of 1, 2, and 3mg rivoglitazone demonstrated HbA1c reduction similar or superior to those observed for pioglitazone 45mg. Limitations in generalizing from this study include a modest sample size and a high rate of discontinuation prior to the last scheduled visit.

Original languageEnglish
Pages (from-to)1321-1331
Number of pages11
JournalCurrent Medical Research and Opinion
Volume26
Issue number6
DOIs
StatePublished - Jun 1 2010

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pioglitazone
Type 2 Diabetes Mellitus
Placebos
Therapeutics
faropenem medoxomil
Safety
2,4-thiazolidinedione
rivoglitazone
Glycosylated Hemoglobin A

Keywords

  • Glycemic control
  • Pioglitazone
  • Rivoglitazone
  • Thiazolidinedione
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A 26-week, placebo-and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. / Truitt, Kenneth E.; Goldberg, Ronald B; Rosenstock, Julio; Chou, Hubert S.; Merante, Domenico; Triscari, Joseph; Wang, Antonia C.

In: Current Medical Research and Opinion, Vol. 26, No. 6, 01.06.2010, p. 1321-1331.

Research output: Contribution to journalArticle

Truitt, Kenneth E. ; Goldberg, Ronald B ; Rosenstock, Julio ; Chou, Hubert S. ; Merante, Domenico ; Triscari, Joseph ; Wang, Antonia C. / A 26-week, placebo-and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. In: Current Medical Research and Opinion. 2010 ; Vol. 26, No. 6. pp. 1321-1331.
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abstract = "Objective: To examine the efficacy and general safety of rivoglitazone, a novel thiazolidinedione, as a treatment for type 2 diabetes in a dose-ranging study over a period of up to 6 months. Research design and methods: A 26-week, randomized, double-blind, double-dummy, placebo-and active comparator (pioglitazone 45mg)-controlled study designed to evaluate the efficacy and safety of once-daily rivoglitazone 1, 2, or 3mg in subjects with type 2 diabetes. The study was conducted in adults with type 2 diabetes (glycated hemoglobin [HbA1c] ≥ 7.0 and <10.5) who were either nave to prior antidiabetes drug treatment or discontinued pre-study antidiabetes medications and were switched to study medication. A total of 441 subjects were randomized, using an equal allocation schedule to one of five treatment arms, including placebo. The primary efficacy measurement was the change in HbA1c from baseline to week 26 in the intent-to-treat population (last observation carried forward), for drug treatments minus placebo (placebo-subtracted). Clinical Trial Registration: ClinicalTrials.gov Identifier NCT00143520 Results: The incidence of early discontinuations was >50, with most cases being related to a lack of efficacy (highest on placebo) or adverse experiences (highest on rivoglitazone 3mg). Rivoglitazone 1, 2, and 3mg and pioglitazone 45mg were more effective than placebo in reducing HbA1c from baseline to week 26 (placebo-subtracted change from baseline:-0.55 [p0.0034],-0.99 [p<0.0001],-1.10 [p<0.0001], and-0.59 [p0.0016], respectively). In general, all treatments were safe. The most common drug-related adverse events reported with rivoglitazone were peripheral edema and weight gain; incidences increased with dose and were higher with rivoglitazone 2 and 3mg than with pioglitazone or rivoglitazone 1mg. Conclusions: Rivoglitazone is a potent thiazolidinedione agent with demonstrated glycemic benefits over a 6-month period in subjects with type 2 diabetes. Once-daily doses of 1, 2, and 3mg rivoglitazone demonstrated HbA1c reduction similar or superior to those observed for pioglitazone 45mg. Limitations in generalizing from this study include a modest sample size and a high rate of discontinuation prior to the last scheduled visit.",
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AU - Goldberg, Ronald B

AU - Rosenstock, Julio

AU - Chou, Hubert S.

AU - Merante, Domenico

AU - Triscari, Joseph

AU - Wang, Antonia C.

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AB - Objective: To examine the efficacy and general safety of rivoglitazone, a novel thiazolidinedione, as a treatment for type 2 diabetes in a dose-ranging study over a period of up to 6 months. Research design and methods: A 26-week, randomized, double-blind, double-dummy, placebo-and active comparator (pioglitazone 45mg)-controlled study designed to evaluate the efficacy and safety of once-daily rivoglitazone 1, 2, or 3mg in subjects with type 2 diabetes. The study was conducted in adults with type 2 diabetes (glycated hemoglobin [HbA1c] ≥ 7.0 and <10.5) who were either nave to prior antidiabetes drug treatment or discontinued pre-study antidiabetes medications and were switched to study medication. A total of 441 subjects were randomized, using an equal allocation schedule to one of five treatment arms, including placebo. The primary efficacy measurement was the change in HbA1c from baseline to week 26 in the intent-to-treat population (last observation carried forward), for drug treatments minus placebo (placebo-subtracted). Clinical Trial Registration: ClinicalTrials.gov Identifier NCT00143520 Results: The incidence of early discontinuations was >50, with most cases being related to a lack of efficacy (highest on placebo) or adverse experiences (highest on rivoglitazone 3mg). Rivoglitazone 1, 2, and 3mg and pioglitazone 45mg were more effective than placebo in reducing HbA1c from baseline to week 26 (placebo-subtracted change from baseline:-0.55 [p0.0034],-0.99 [p<0.0001],-1.10 [p<0.0001], and-0.59 [p0.0016], respectively). In general, all treatments were safe. The most common drug-related adverse events reported with rivoglitazone were peripheral edema and weight gain; incidences increased with dose and were higher with rivoglitazone 2 and 3mg than with pioglitazone or rivoglitazone 1mg. Conclusions: Rivoglitazone is a potent thiazolidinedione agent with demonstrated glycemic benefits over a 6-month period in subjects with type 2 diabetes. Once-daily doses of 1, 2, and 3mg rivoglitazone demonstrated HbA1c reduction similar or superior to those observed for pioglitazone 45mg. Limitations in generalizing from this study include a modest sample size and a high rate of discontinuation prior to the last scheduled visit.

KW - Glycemic control

KW - Pioglitazone

KW - Rivoglitazone

KW - Thiazolidinedione

KW - Type 2 diabetes mellitus

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