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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: 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

  Show 109 Study Locations
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  
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 March 24, 2017