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A New Oral Treatment For Type II Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00111800
Recruitment Status : Completed
First Posted : May 26, 2005
Results First Posted : March 13, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: DEN 2.5 mg Drug: DEN 7.5 mg Drug: DEN 15 mg Drug: DEN 30 mg Drug: DEN 45 mg Phase 2

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 28, 2005
Actual Primary Completion Date : July 1, 2006
Actual Study Completion Date : July 21, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Drug: 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.
Drug: DEN 2.5 mg
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other Name: 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.
Drug: DEN 7.5 mg
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other Name: 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.
Drug: DEN 15 mg
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other Name: 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.
Drug: DEN 30 mg
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other Name: 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.
Drug: DEN 45 mg
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other Name: GW823093 45 mg




Primary Outcome Measures :
  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 [ Time Frame: 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.

  2. Change From Baseline in FPG at Week 12 [ Time Frame: 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.

  3. Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 [ Time Frame: 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.

  4. Number of Participants Who Were HbA1c Responders at Week 12 [ Time Frame: 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.

  5. Number of Participants of FPG Responders at Week 12 [ Time Frame: 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.

  6. Change From Baseline in Fructosamine at Week 12 [ Time Frame: 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.

  7. Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 [ Time Frame: 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.

  8. Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 [ Time Frame: 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.

  9. Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 [ Time Frame: 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.

  10. Change From Baseline in Pro-insulin at Week 16, 20 and 24. [ Time Frame: 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.

  11. Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 [ Time Frame: 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.

  12. Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 [ Time Frame: 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.

  13. Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia [ Time Frame: 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.

  14. Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe [ Time Frame: 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.

  15. Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy [ Time Frame: 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.

  16. Change From Baseline in Body Weight Over Time [ Time Frame: 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.

  17. Change From Baseline in Body Mass Index (BMI) Over Time [ Time Frame: 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.

  18. Change From Baseline in Waist Circumference and Hip Circumference Over Time [ Time Frame: 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.

  19. Mean Change From Baseline in Waist to Hip Ratio Over Time [ Time Frame: 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.

  20. Change From Baseline in 12-lead ECG Over Time [ Time Frame: 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.

  21. Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy [ Time Frame: 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.

  22. Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy [ Time Frame: 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.

  23. Number of Participants With Abnormal Urinalysis Dipstick Result [ Time Frame: 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).

  24. Number of Participants With Urinalysis Microscopic Result [ Time Frame: 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).

  25. Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN [ Time Frame: 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.

  26. Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111800


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

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100925
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00111800     History of Changes
Other Study ID Numbers: DPB100925
First Posted: May 26, 2005    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
NIDDM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases