Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects on Glycemic Control With Concomitantly Administered Pioglitazone HCl and Metformin HCl Extended Release (Fortamet®) in Subjects With Type 2 Diabetes
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Pioglitazone (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones. The insulin-sensitizing actions of thiazolidinediones are at least partially mediated through the peroxisome proliferator-activated receptor gamma. These receptors are found primarily in adipocytes, vascular endothelial cells, monocytes, hepatocytes, and to a lesser extent myocytes.
Metformin was developed as an extended-release formulation of metformin hydrochloride and designed for once-a-day oral administration. Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with, type 2 diabetes, lowering both basal and postprandial plasma glucose.
On 15 July 1999, the FDA approved pioglitazone for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Pioglitazone is indicated for monotherapy and for use in combination with sulfonylureas, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control. On 26 November 2003, the FDA approved the combined use of pioglitazone with metformin.
This study is designed to evaluate the effect on glycemic control when pioglitazone and metformin are taken together. Individuals participating in this study will provide written informed consent and will be required to commit to a screening visit and approximately 5 additional visits at the study center. Study participation is anticipated to be about 31 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
- Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise.
- If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization.
- If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization.
Exclusion Criteria
- Has type 1 diabetes mellitus
- Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening
- Has congestive heart failure; has a triglyceride level greater than 500 mg per dL
- Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg
- Body mass index greater than or equal to 42 kg/m2 (weight /height2)
- Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization.
- Currently using insulin or has used insulin 3 months prior to Screening
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone)
- Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study
- Chronically used steroid-joint injections - 3 months prior to screening and during the study
- Thiazolidinediones - 3 months prior to screening and during the study
- Insulin - 3 months prior to screening
- Other oral antidiabetic medications (eg, nateglinide [Starlix], acarbose [Precose]) with the exception of sulfonylurea - 3 months prior to screening and during the study
- Metformin - Fortamet Stabilization and during the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Pioglitazone 30 mg QD + Metformin 1000 mg QD
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Pioglitazone 30 mg, tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
Outros nomes:
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Comparador Ativo: Metformin 1000 mg QD
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Pioglitazone placebo-matching tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change from randomization in Glycosylated Hemoglobin
Prazo: Final Visit
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Final Visit
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change from randomization in Fasting Plasma Glucose
Prazo: Final Visit
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Final Visit
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Change from randomization in Insulin
Prazo: Final Visit
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Final Visit
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Change from randomization in Pro-Insulin
Prazo: Final Visit
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Final Visit
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Change from randomization in Homeostasis Model Assessment
Prazo: Final Visit
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Final Visit
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Change from randomization in Triglycerides
Prazo: Final Visit
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Final Visit
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Change from randomization in Total Cholesterol
Prazo: Final Visit
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Final Visit
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Change from randomization in Low-Density Lipoprotein Cholesterol
Prazo: Final Visit
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Final Visit
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Change from randomization in high-density Lipoprotein Cholesterol
Prazo: Final Visit
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Final Visit
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Change from randomization in Lipid Fractionation
Prazo: Final Visit
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Final Visit
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Change from randomization in High Sensitivity C-Reactive Protein
Prazo: Final Visit
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Final Visit
|
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Change from randomization in Creatine Phosphokinase
Prazo: Final Visit
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Final Visit
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01-05-TL-OPIXT-010
- U1111-1114-2423 (Identificador de registro: WHO)
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