GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01217112 |
Recruitment Status :
Completed
First Posted : October 8, 2010
Results First Posted : January 20, 2014
Last Update Posted : September 18, 2014
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Sponsor:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Jazz Pharmaceuticals
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Dyslipidemias Diabetes Mellitus, Type 2 |
Interventions |
Drug: GWP42003 Drug: GWP42004 Drug: Placebo |
Enrollment | 62 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 1:1 GWP42003 : GWP42004 | 20:1 GWP42003 : GWP42004 | GWP42003 and Placebo | GWP42004 and Placebo | Placebo |
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Contains 5 mg each of GWP42003 and GWP42004 | Contains 100 mg GWP42003 and 5 mg GWP42004 | Contains 100 mg GWP42003 and placebo (excipients only) | Contains GWP42004 5 mg and placebo (excipients only) | Contains excipients only |
Period Title: Overall Study | |||||
Started | 11 | 12 | 13 | 12 | 14 |
Completed | 11 | 10 | 12 | 10 | 13 |
Not Completed | 0 | 2 | 1 | 2 | 1 |
Reason Not Completed | |||||
Adverse Event | 0 | 2 | 0 | 2 | 0 |
Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Physician Decision | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | 1:1 GWP42003 : GWP42004 | 20:1 GWP42003 : GWP42004 | GWP42003 and Placebo | GWP42004 and Placebo | Placebo | Total | |
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Contains 5 mg each of GWP42003 and GWP42004 | Contains 100 mg GWP42003 and 5 mg GWP42004 | Contains 100 mg GWP42003 and placebo (excipients only) | Contains GWP42004 5 mg and placebo (excipients only) | Contains excipients only | Total of all reporting groups | |
Overall Number of Baseline Participants | 11 | 12 | 13 | 12 | 14 | 62 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 12 participants | 13 participants | 12 participants | 14 participants | 62 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
8 72.7%
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11 91.7%
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11 84.6%
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8 66.7%
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10 71.4%
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48 77.4%
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>=65 years |
3 27.3%
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1 8.3%
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2 15.4%
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4 33.3%
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4 28.6%
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14 22.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 11 participants | 12 participants | 13 participants | 12 participants | 14 participants | 62 participants | |
59.33 (8.75) | 57.96 (8.11) | 56.80 (9.92) | 62.45 (12.58) | 58.63 (7.72) | 58.98 (9.41) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 12 participants | 13 participants | 12 participants | 14 participants | 62 participants | |
Female |
5 45.5%
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3 25.0%
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3 23.1%
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2 16.7%
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7 50.0%
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20 32.3%
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Male |
6 54.5%
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9 75.0%
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10 76.9%
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10 83.3%
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7 50.0%
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42 67.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United Kingdom | Number Analyzed | 11 participants | 12 participants | 13 participants | 12 participants | 14 participants | 62 participants |
11 | 12 | 13 | 12 | 14 | 62 |