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A New Oral Treatment For Type II Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00111800
First received: May 25, 2005
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Drug: GW0823093 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline (Week 0) in HbA1c (Glycosylated haemoglobin) at Week 12. [ Time Frame: Baseline (Week 0) and Week 12 ]

Secondary Outcome Measures:
  • Mean change from baseline (Week 0) in HbA1c at Week 4, 8, 16, 20 and 24 [ Time Frame: Baseline (Week 0), Week 4 and Week 8 ]
  • Mean change from baseline (Week 0) in fasting plasma glucose (FPG) at Week 12 [ Time Frame: Baseline (Week 0) and Week 12 ]
  • Mean change from baseline (Week 0) in fasting plasma glucose (FPG) at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 [ Time Frame: Baseline (Week 0), Week 1, 2, 3, 4, 6 and 8 ]
  • Percentage of participants who achieved HbA1c ≤6.5% and <7% targets and achieved a clinically meaningful decrease in HbA1c (≥0.7%). [ Time Frame: Week 12 ]
  • Percentage of participants who achieved FPG (<126mg/dL [7.0mmol/L] target, and achieved a clinically meaningful decrease in FPG (≥30mg/dL [1.7mmol/L]). [ Time Frame: Week 12 ]
  • Mean change from baseline (Week 0) in fructosamine at Week 12. [ Time Frame: Baseline (Week 0) and Week 12 ]
  • Mean change from baseline (Week 0) in fructosamine at Weeks 4, 8, 16, 20 and 24. [ Time Frame: Baseline (Week 0), Week 16, 20 and 24 ]
  • Mean change from baseline (Week 0) in fasting serum insulin and pro-insulin at Week 12. [ Time Frame: Baseline (Week 0) and Week 12 ]
  • Mean change from baseline (Week 0) in fasting serum insulin at Weeks 4, 8, 16, 20, 24 and pro-insulin at Weeks 4 and 8 [ Time Frame: Baseline (Week 0), Week 4 and 8 ]
  • Mean change from baseline (Week 0) in pro-insulin at Weeks 16, 20 and 24. [ Time Frame: Baseline (Week 0), Week 16, 20 and 24 ]
  • Mean change from baseline (Week 0) in pro-insulin : insulin ratio at Week 12. [ Time Frame: Baseline (Week 0) and Week 12 ]
  • Mean change from baseline (Week 0) in pro-insulin : insulin ratio at Weeks 4 and 8. [ Time Frame: Baseline (Week 0), Week 4 and 8 ]
  • Number of participants with any adverse events (AE) or serious adverse events (SAE) and events of hypoglycaemia. [ Time Frame: Week 0 to Week 24 ]
  • Number of participants with AE and event of hypoglycaemia of mild, moderate and severe. [ Time Frame: Week 0 to Week 24 ]
  • Number of participants with change from baseline value of Potential Clinical Concern (PCC) in vital signs at any time during treatment. [ Time Frame: Baseline (Week 0) and Week -5 to 25 (follow- up) ]
  • Mean change from baseline (Week 0) in body weight at each visit. [ Time Frame: Baseline (Week 0) and Week -5 to 25 (follow - up) ]
  • Mean change from baseline (Week 0) in body mass index (BMI) at each visit [ Time Frame: Baseline (Week 0) and Week -5 to 25 (follow- up) ]
  • Mean change from baseline (Week 0) in waist circumference and hip circumference at Week 24 [ Time Frame: Baseline (Week 0) and Week 24 ]
  • Mean change from baseline (Week 0) in waist : hip ratio at Week 24. [ Time Frame: Baseline (Week 0) and Week 24 ]
  • Mean change from baseline (Week 0) in 12-lead electrocardiogram (ECG) at Week 16 and 24. [ Time Frame: Baseline (Week 0), Week 16 and 24 ]
  • Number of participants with laboratory clinical chemistry values of Potential Clinical Concern (PCC) at any time on therapy. [ Time Frame: Week 0 to Week 24 ]
  • Number of participants with laboratory haematology values of PCC at any time on therapy. [ Time Frame: Week 0 to Week 24 ]
  • Number of participants with urinalysis dipstick result at each visit. [ Time Frame: Baseline (Week 0) and Week -5 to 25 (follow-up) ]
  • Number of participants with urinalysis microscopic result at each visit. [ Time Frame: Baseline (Week 0) and Week -5 to 25 (follow-up) ]

Enrollment: 366
Study Start Date: April 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: GW0823093

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Borough, 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 3J1
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
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 51
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 87
GSK Investigational Site
Cheb, Czech Republic, 350 02
GSK Investigational Site
Liberec, Czech Republic, 46004
GSK Investigational Site
Praha 2, Czech Republic, 128 21
GSK Investigational Site
Praha 5, Czech Republic, 150 05
GSK Investigational Site
Praha 5, Czech Republic, 158 00
GSK Investigational Site
Trebic, Czech Republic, 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
  More Information

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
Study First Received: May 25, 2005
Last Updated: March 21, 2017
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.

Keywords provided by GlaxoSmithKline:
NIDDM

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

ClinicalTrials.gov processed this record on August 22, 2017