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A New Oral Treatment For Type II Diabetes Mellitus

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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

May 25, 2005
May 26, 2005
July 20, 2017
March 13, 2018
March 21, 2018
April 28, 2005
July 1, 2006   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00111800 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
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A New Oral Treatment For Type II Diabetes Mellitus
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.
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: DEN 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.
    Intervention: Drug: DEN 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.
    Intervention: Drug: DEN 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.
    Intervention: Drug: DEN 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.
    Intervention: Drug: DEN 45 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
375
Not Provided
July 21, 2006
July 1, 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czechia,   Finland,   Germany,   Greece,   Latvia,   Puerto Rico,   Romania,   Sweden,   United States
Czech Republic
 
NCT00111800
DPB100925
Not Provided
Not Provided
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://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP