Last updated: 11/04/2018 06:11:51
A New Oral Treatment For Type II Diabetes Mellitus
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Secondary outcomes:
Change from Baseline in HbA1c at Week 4, 8, 16, 20 and 24
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in FPG at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24
Timeframe: Baseline (Week 0) up to Week 24
Number of participants who were HbA1c responders at Week 12
Timeframe: Week 12
Number of participants of FPG responders at Week 12
Timeframe: Week 12
Change from Baseline in fructosamine at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in fructosamine at Weeks 4, 8, 16, 20 and 24
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in fasting serum insulin and pro-insulin at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in fasting serum insulin at Weeks 4, 8, 16, 20, 24 and pro-insulin at Weeks 4 and 8
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in pro-insulin at Week 16, 20 and 24.
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in pro-insulin to insulin ratio at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in pro-insulin to insulin ratio at Week 4 and 8
Timeframe: Baseline (Week 0) and Week 4 and 8
Number of participants with any adverse events (AE) or serious adverse events (SAE) and events of hypoglycaemia
Timeframe: Up to Week 25
Number of participants with AE and event of hypoglycaemia of mild, moderate and severe
Timeframe: Up to Week 25
Number of participants with change from Baseline value of potential clinical concern (PCC) in vital signs at any time during therapy
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in body weight over time
Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change from Baseline in body mass index (BMI) over time
Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change from Baseline in waist circumference and hip circumference over time
Timeframe: Baseline (Week 0) up to Week 24
Mean change from Baseline in waist to hip ratio over time
Timeframe: Baseline (Week 0) up to Week 24
Change from Baseline in 12-lead ECG over time
Timeframe: Baseline (Week 0) up to Week 24
Number of participants with laboratory clinical chemistry values of PCC at any time on therapy
Timeframe: Up to Week 24
Number of participants with laboratory haematology values of PCC at any time on therapy
Timeframe: Up to Week 24
Number of participants with abnormal urinalysis dipstick result
Timeframe: Up to Follow-up (Week 25)
Number of participants with urinalysis microscopic result
Timeframe: Up to Follow-up (Week 25)
Population pharmacokinetic (PK) parameter of plasma concentration of DEN
Timeframe: 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
Descriptive statistics of dipeptidyl peptidase-IV (DPP-IV) inhibition performed as part of the population PK
Timeframe: 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
Interventions:
Drug: Placebo
Drug: DEN 2.5 mg
Drug: DEN 7.5 mg
Drug: DEN 15 mg
Drug: DEN 30 mg
Drug: DEN 45 mg
Enrollment:
375
Observational study model:
Not applicable
Primary completion date:
2006-26-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
denagliptin
Collaborators
Not applicable
Study date(s)
April 2005 to April 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Women must not be pregnant and must not be breastfeeding.
- Have Type II diabetes.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Oxon Hill, Maryland, United States, 20745
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Ingelheim, Rheinland-Pfalz, Germany, 55218
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30066
Status
Study Complete
Location
GSK Investigational Site
Sewickley, Pennsylvania, United States, 15143
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Study Complete
Location
GSK Investigational Site
Jefferson Borough, Pennsylvania, United States, 15025
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lueneburg, Niedersachsen, Germany, 21335
Status
Study Complete
Location
GSK Investigational Site
Offenbach, Hessen, Germany, 63073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, Washington, United States, 98664
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Location
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Stockach, Baden-Wuerttemberg, Germany, 78333
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98403
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98226
Status
Study Complete
Location
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bammental, Baden-Wuerttemberg, Germany, 69245
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91105
Status
Study Complete
Location
GSK Investigational Site
Kippenheim, Baden-Wuerttemberg, Germany, 77971
Status
Study Complete
Location
GSK Investigational Site
Bad Lauterberg, Niedersachsen, Germany, 37431
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Speyer, Rheinland-Pfalz, Germany, 67346
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Koenigsfeld, Baden-Wuerttemberg, Germany, 78126
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76017
Status
Study Complete
Location
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 87
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-26-04
Actual study completion date
2006-26-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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