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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
May 25, 2005
March 21, 2017
April 2005
July 2006   (Final data collection date for primary outcome measure)
Mean change from baseline (Week 0) in HbA1c (Glycosylated haemoglobin) at Week 12. [ Time Frame: Baseline (Week 0) and Week 12 ]
Not Provided
Complete list of historical versions of study NCT00111800 on ClinicalTrials.gov Archive Site
  • 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) ]
Not Provided
Not Provided
Not Provided
 
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: GW0823093
Experimental: Arm 1
Intervention: Drug: GW0823093
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
July 2006
July 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, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Finland,   Germany,   Greece,   Latvia,   Puerto Rico,   Romania,   Sweden,   United States
 
 
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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