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Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)

9 de agosto de 2018 atualizado por: Merck Sharp & Dohme LLC

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin

This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

307

Estágio

  • Fase 3

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus
  • Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea
  • Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to study participation.
  • History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
  • On a weight loss program and is not in the maintenance phase; or has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation.
  • Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)
  • Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
  • Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Human immunodeficiency virus (HIV)
  • New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
  • Poorly controlled hypertension
  • History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug
  • Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking
  • Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Omarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Omarigliptin 25 mg capsule administered orally once a week
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
Outros nomes:
  • Amaryl®
  • Glimy
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
Outros nomes:
  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
Comparador de Placebo: Placebo
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
Outros nomes:
  • Amaryl®
  • Glimy
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
Outros nomes:
  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
Matching placebo to omarigliptin capsule administered orally once a week

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Prazo: Baseline and Week 24
A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Prazo: Up to Week 27
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Up to Week 27
Percentage of Participants Who Discontinued From the Study Due to an AE
Prazo: Up to Week 24
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Up to Week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Prazo: Baseline and Week 24
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Baseline and Week 24
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24
Prazo: 24 weeks
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.
24 weeks

Colaboradores e Investigadores

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Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de outubro de 2012

Conclusão Primária (Real)

23 de dezembro de 2014

Conclusão do estudo (Real)

23 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

8 de outubro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de outubro de 2012

Primeira postagem (Estimativa)

11 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de agosto de 2018

Última verificação

1 de agosto de 2018

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Dados/documentos do estudo

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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