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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: October 13, 2016
Last verified: October 2016

May 25, 2005
October 13, 2016
April 2005
July 2006   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at Week 12.
Not Provided
Complete list of historical versions of study NCT00111800 on ClinicalTrials.gov Archive Site
  • Change in HbA1c, FPG, fructosamine, insulin, pro-insulin, ECG, vital signs, BMI, waist/ hip circumference and weight.
  • Proportion of subjects who achieve predefined decreases or targets in HBA1c and FPG. PopPK. AEs, hypos and lab measures.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Finland,   Germany,   Greece,   Latvia,   Puerto Rico,   Romania,   Sweden
 
NCT00111800
DPB100925
Not Provided
Yes
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
October 2016

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