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A New Oral Treatment For Type II Diabetes Mellitus

19 de março de 2018 atualizado por: GlaxoSmithKline

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus Followed by a 12-week Active Treatment Extension

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Tipo de estudo

Intervencional

Inscrição (Real)

375

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
    • Baden-Wuerttemberg
      • Bammental, Baden-Wuerttemberg, Alemanha, 69245
        • GSK Investigational Site
      • Deggingen, Baden-Wuerttemberg, Alemanha, 73326
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Alemanha, 69120
        • GSK Investigational Site
      • Kippenheim, Baden-Wuerttemberg, Alemanha, 77971
        • GSK Investigational Site
      • Koenigsfeld, Baden-Wuerttemberg, Alemanha, 78126
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Alemanha, 77654
        • GSK Investigational Site
      • Sinsheim, Baden-Wuerttemberg, Alemanha, 74889
        • GSK Investigational Site
      • Stockach, Baden-Wuerttemberg, Alemanha, 78333
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Alemanha, 69469
        • GSK Investigational Site
    • Bayern
      • Haag, Bayern, Alemanha, 83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn, Bayern, Alemanha, 85635
        • GSK Investigational Site
    • Hessen
      • Bad Kreuznach, Hessen, Alemanha, 55545
        • GSK Investigational Site
      • Hirschhorn, Hessen, Alemanha, 69434
        • GSK Investigational Site
      • Kelkheim, Hessen, Alemanha, 65779
        • GSK Investigational Site
      • Offenbach, Hessen, Alemanha, 63067
        • GSK Investigational Site
      • Offenbach, Hessen, Alemanha, 63073
        • GSK Investigational Site
    • Niedersachsen
      • Bad Lauterberg, Niedersachsen, Alemanha, 37431
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Alemanha, 21335
        • GSK Investigational Site
      • Tostedt, Niedersachsen, Alemanha, 21255
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Ingelheim, Rheinland-Pfalz, Alemanha, 55218
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Alemanha, 55116
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Alemanha, 55624
        • GSK Investigational Site
      • Speyer, Rheinland-Pfalz, Alemanha, 67346
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Alemanha, 01129
        • GSK Investigational Site
      • Dresden, Sachsen, Alemanha, 01219
        • GSK Investigational Site
      • Freital, Sachsen, Alemanha, 01705
        • GSK Investigational Site
      • Pirna, Sachsen, Alemanha, 01796
        • GSK Investigational Site
      • Schmiedeberg, Sachsen, Alemanha, 01762
        • GSK Investigational Site
  • Canadá
    • British Columbia
      • Coquitlam, British Columbia, Canadá, V3K 3P4
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 3P4
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canadá, A0G 1G0
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canadá, L6T 3T1
        • GSK Investigational Site
      • Toronto, Ontario, Canadá, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canadá, M4R 2G4
        • GSK Investigational Site
      • Waterloo, Ontario, Canadá, N2J 1C4
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Canadá, J8Y 6S8
        • GSK Investigational Site
      • Mirabel, Quebec, Canadá, J7J 2K8
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canadá, H9R 4S3
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canadá, G1W 4R4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canadá, J1H 4J6
        • GSK Investigational Site
  • Estados Unidos
    • California
      • Long Beach, California, Estados Unidos, 90806
        • GSK Investigational Site
      • Pasadena, California, Estados Unidos, 91105
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Estados Unidos, 80220
        • GSK Investigational Site
    • Florida
      • Hollywood, Florida, Estados Unidos, 33021
        • GSK Investigational Site
      • Miami, Florida, Estados Unidos, 33126
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • GSK Investigational Site
      • Marietta, Georgia, Estados Unidos, 30066
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60607
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, Estados Unidos, 70584
        • GSK Investigational Site
    • Maryland
      • Oxon Hill, Maryland, Estados Unidos, 20745
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • GSK Investigational Site
      • Pahrump, Nevada, Estados Unidos, 89048
        • GSK Investigational Site
    • New York
      • Albany, New York, Estados Unidos, 12208
        • GSK Investigational Site
      • Buffalo, New York, Estados Unidos, 14209
        • GSK Investigational Site
      • Johnson City, New York, Estados Unidos, 13790
        • GSK Investigational Site
      • Rochester, New York, Estados Unidos, 14642
        • GSK Investigational Site
      • Syracuse, New York, Estados Unidos, 13210
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • GSK Investigational Site
      • Raleigh, North Carolina, Estados Unidos, 27612
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45246
        • GSK Investigational Site
      • Kettering, Ohio, Estados Unidos, 45429
        • GSK Investigational Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Estados Unidos, 15025
        • GSK Investigational Site
      • Sewickley, Pennsylvania, Estados Unidos, 15143
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29201
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Estados Unidos, 37660
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, Estados Unidos, 76017
        • GSK Investigational Site
      • Dallas, Texas, Estados Unidos, 75246
        • GSK Investigational Site
      • Dallas, Texas, Estados Unidos, 75230
        • GSK Investigational Site
      • San Antonio, Texas, Estados Unidos, 78237
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84102
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Estados Unidos, 22015
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Estados Unidos, 98226
        • GSK Investigational Site
      • Tacoma, Washington, Estados Unidos, 98403
        • GSK Investigational Site
      • Vancouver, Washington, Estados Unidos, 98664
        • GSK Investigational Site
  • Finlândia
      • Helsinki, Finlândia, 00260
        • GSK Investigational Site
      • Kuopio, Finlândia, 70210
        • GSK Investigational Site
      • Oulu, Finlândia, 90100
        • GSK Investigational Site
  • Grécia
      • Athens, Grécia, 115 26
        • GSK Investigational Site
      • Heraklion, Crete, Grécia, 71409
        • GSK Investigational Site
      • Lavrio, Grécia, 19500
        • GSK Investigational Site
      • Melissia, Grécia, 15127
        • GSK Investigational Site
      • Thessaloniki, Grécia, 564 29
        • GSK Investigational Site
      • Thessaloniki, Grécia, 546 42
        • GSK Investigational Site
      • Thessaloniki, Grécia, 551 32
        • GSK Investigational Site
      • Thessaloniki, Grécia, 564 34
        • GSK Investigational Site
  • Letônia
      • Jelgava, Letônia, LV 3001
        • GSK Investigational Site
      • Ogre, Letônia, LV 5001
        • GSK Investigational Site
      • Riga, Letônia, LV 1002
        • GSK Investigational Site
      • Riga, Letônia, LV1079
        • GSK Investigational Site
      • Riga, Letônia, LV1002
        • GSK Investigational Site
      • Talsi, Letônia, LV 3201
        • GSK Investigational Site
      • Valmiera, Letônia, LV 4201
        • GSK Investigational Site
  • Porto Rico
      • Ponce, Porto Rico, 00716
        • GSK Investigational Site
  • Romênia
      • Brasov, Romênia, 500366
        • GSK Investigational Site
      • Bucharest, Romênia, 020475
        • GSK Investigational Site
      • Bucharest, Romênia, 020045
        • GSK Investigational Site
  • Suécia
      • Göteborg, Suécia, SE-413 45
        • GSK Investigational Site
      • Malmö, Suécia, SE-205 02
        • GSK Investigational Site
      • Stockholm, Suécia, SE-182 88
        • GSK Investigational Site
  • Tcheca
      • Brno, Tcheca, 656 51
        • GSK Investigational Site
      • Ceske Budejovice, Tcheca, 370 87
        • GSK Investigational Site
      • Cheb, Tcheca, 350 02
        • GSK Investigational Site
      • Liberec, Tcheca, 46004
        • GSK Investigational Site
      • Praha 2, Tcheca, 128 21
        • GSK Investigational Site
      • Praha 5, Tcheca, 158 00
        • GSK Investigational Site
      • Praha 5, Tcheca, 150 05
        • GSK Investigational Site
      • Trebic, Tcheca, 674 01
        • GSK Investigational Site

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 a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion criteria:

  • Women must not be pregnant and must not be breastfeeding.
  • Have Type II diabetes.
  • Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

  • Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
Medicamento: Placebo
Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Experimental: DEN 2.5 mg
Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
Medicamento: DEN 2.5 mg
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Outros nomes:
  • GW823093 2.5 mg
Experimental: DEN 7.5 mg
Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
Medicamento: DEN 7.5 mg
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Outros nomes:
  • GW823093 7.5 mg
Experimental: DEN 15 mg
Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
Medicamento: DEN 15 mg
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Outros nomes:
  • GW823093 15 mg
Experimental: DEN 30 mg
Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Medicamento: DEN 30 mg
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Outros nomes:
  • GW823093 30 mg
Experimental: DEN 45 mg
Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Medicamento: DEN 45 mg
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Outros nomes:
  • GW823093 45 mg

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Prazo: Baseline (Week 0) and Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.
Baseline (Week 0) and Week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24
Prazo: Baseline (Week 0) up to Week 24
HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in FPG at Week 12
Prazo: Baseline (Week 0) and Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24
Prazo: Baseline (Week 0) up to Week 24
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Number of Participants Who Were HbA1c Responders at Week 12
Prazo: Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of <=6.5%, <7% and HbA1c reduction of >=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Week 12
Number of Participants of FPG Responders at Week 12
Prazo: Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of <7 mmol/L and FPG reduction value of >=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Week 12
Change From Baseline in Fructosamine at Week 12
Prazo: Baseline (Week 0) and Week 12
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24
Prazo: Baseline (Week 0) up to Week 24
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12
Prazo: Baseline (Week 0) and Week 12
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8
Prazo: Baseline (Week 0) up to Week 24
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Pro-insulin at Week 16, 20 and 24.
Prazo: Baseline (Week 0) up to Week 24
The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Pro-insulin to Insulin Ratio at Week 12
Prazo: Baseline (Week 0) and Week 12
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8
Prazo: Baseline (Week 0) and Week 4 and 8
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 4 and 8
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia
Prazo: Up to Week 25
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.
Up to Week 25
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe
Prazo: Up to Week 25
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.
Up to Week 25
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy
Prazo: Baseline (Week 0) up to Week 24
The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline >30 beats per minute (bpm) and <50 or >120 bpm; SBP increase or decrease from Baseline >30 millimeter of mercury (mmHg) in the same posture and >170 or <100 mmHg; increase or decrease from Baseline >20 mmHg in same posture and >110 or <50 mmHg.
Baseline (Week 0) up to Week 24
Change From Baseline in Body Weight Over Time
Prazo: Baseline (Week 0) and Week -5 to 25 (Follow-up)
The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change From Baseline in Body Mass Index (BMI) Over Time
Prazo: Baseline (Week 0) and Week -5 to 25 (Follow-up)
BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change From Baseline in Waist Circumference and Hip Circumference Over Time
Prazo: Baseline (Week 0) up to Week 24
Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Mean Change From Baseline in Waist to Hip Ratio Over Time
Prazo: Baseline (Week 0) up to Week 24
Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in 12-lead ECG Over Time
Prazo: Baseline (Week 0) up to Week 24
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy
Prazo: Up to Week 24
The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase ([LDH] if >2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Up to Week 24
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy
Prazo: Up to Week 24
The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Up to Week 24
Number of Participants With Abnormal Urinalysis Dipstick Result
Prazo: Up to Follow-up (Week 25)
The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Up to Follow-up (Week 25)
Number of Participants With Urinalysis Microscopic Result
Prazo: Up to Follow-up (Week 25)
The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Up to Follow-up (Week 25)
Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN
Prazo: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK
Prazo: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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)

28 de abril de 2005

Conclusão Primária (Real)

1 de julho de 2006

Conclusão do estudo (Real)

21 de julho de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de maio de 2005

Primeira postagem (Estimativa)

26 de maio de 2005

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de março de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de março de 2018

Última verificação

1 de março de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DPB100925

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dados/documentos do estudo

  1. Conjunto de dados de participantes individuais
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Relatório de Estudo Clínico
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Especificação do conjunto de dados
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulário de Consentimento Informado
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Relato de Caso Anotado
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocolo de estudo
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plano de Análise Estatística
    Identificador de informação: 100925
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

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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