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A New Oral Treatment For Type II Diabetes Mellitus

19. mars 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

375

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 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.
Legemiddel: Placebo
Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Eksperimentell: 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.
Legemiddel: DEN 2.5 mg
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Andre navn:
  • GW823093 2.5 mg
Eksperimentell: 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.
Legemiddel: DEN 7.5 mg
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Andre navn:
  • GW823093 7.5 mg
Eksperimentell: 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.
Legemiddel: DEN 15 mg
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Andre navn:
  • GW823093 15 mg
Eksperimentell: 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.
Legemiddel: DEN 30 mg
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Andre navn:
  • GW823093 30 mg
Eksperimentell: 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.
Legemiddel: DEN 45 mg
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Andre navn:
  • GW823093 45 mg

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

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Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. april 2005

Primær fullføring (Faktiske)

1. juli 2006

Studiet fullført (Faktiske)

21. juli 2006

Datoer for studieregistrering

Først innsendt

25. mai 2005

Først innsendt som oppfylte QC-kriteriene

25. mai 2005

Først lagt ut (Anslag)

26. mai 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DPB100925

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Datasett for individuell deltaker
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk studierapport
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasettspesifikasjon
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Skjema for informert samtykke
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotert saksrapportskjema
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokoll
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistisk analyseplan
    Informasjonsidentifikator: 100925
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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