Last updated: 11/04/2018 06:12:01
GW823093C For The Treatment Of Type 2 Diabetes Mellitus
GSK study ID
DPB106652
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: GW823093 Japan Phase IIa Mono
Trial description: This study was designed to find dose response and as extension in treatment of GW823093C.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Timeframe: 12 weeks
Secondary outcomes:
Long term safety variables
Timeframe: 64 weeks
Interventions:
Drug: GW823093C A
Drug: GW823093C B
Drug: GW823093C C
Enrollment:
159
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
denagliptin
Collaborators
GSK
Study date(s)
April 2006 to November 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
20 - 74 years
Accepts healthy volunteers
No
- Type 2 diabetes mellitus.
- Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))
- Patients who have metabolic disease judged by investigator as a clinically significance
- Serious cardiovascular disease or serious hepatic disease
Inclusion and exclusion criteria
Inclusion criteria:
- Type 2 diabetes mellitus.
- Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))
Exclusion criteria:
- Patients who have metabolic disease judged by investigator as a clinically significance
- Serious cardiovascular disease or serious hepatic disease
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2006-25-11
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
Additional information
Not applicable
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