Trial · NCT01217112
GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
NCT01217112, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2014-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes. Trials, record NCT01217112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217112
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
- NCT number
- NCT01217112
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Dyslipidemias, Diabetes Mellitus, Type 2
- Interventions
- GWP42003, GWP42003, GWP42004, Placebo
- First posted
- 2010-10-08
- Last updated
- 2022-10-18
- Other registries' IDs
- eudract:2010-020458-33
- Results first posted
- 2014-01-20
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement. |
| Secondary | The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement. |
| Secondary | The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
| Secondary | The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | ratio | MEAN |
| SECONDARY | The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | ratio | MEAN |
| SECONDARY | The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
| SECONDARY | The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment | Baseline (Day 1) and End of treatment (Day 92) | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | mmol/l | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group220
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 1:1 GWP42003 : GWP42004 | 0.00 | Standard Deviation 0.09 | mmol/l | |
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 20:1 GWP42003 : GWP42004 | 0.04 | Standard Deviation 0.07 | mmol/l | |
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | GWP42003 and Placebo | -0.04 | Standard Deviation 0.14 | mmol/l | |
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | GWP42004 and Placebo | 0.00 | Standard Deviation 0.14 | mmol/l | |
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | Placebo | 0.02 | Standard Deviation 0.09 | mmol/l | |
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 1:1 GWP42003 : GWP42004 | -0.04 | Standard Deviation 0.12 | mmol/l | |
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 20:1 GWP42003 : GWP42004 | -0.06 | Standard Deviation 0.08 | mmol/l | |
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | GWP42003 and Placebo | -0.11 | Standard Deviation 0.08 | mmol/l | |
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | GWP42004 and Placebo | -0.01 | Standard Deviation 0.16 | mmol/l | |
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | Placebo | -0.02 | Standard Deviation 0.11 | mmol/l |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1:1 GWP42003 : GWP42004 | 11 | |
| Overall Study | STARTED | 20:1 GWP42003 : GWP42004 | 12 | |
| Overall Study | STARTED | GWP42003 and Placebo | 13 | |
| Overall Study | STARTED | GWP42004 and Placebo | 12 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | COMPLETED | 1:1 GWP42003 : GWP42004 | 11 | |
| Overall Study | COMPLETED | 20:1 GWP42003 : GWP42004 | 10 | |
| Overall Study | COMPLETED | GWP42003 and Placebo | 12 | |
| Overall Study | COMPLETED | GWP42004 and Placebo | 10 | |
| Overall Study | COMPLETED | Placebo | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events395
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Myocardial infarction | Cardiac disorders | 1:1 GWP42003 : GWP42004 | 0 | 11 | |
| other | Myocardial infarction | Cardiac disorders | 20:1 GWP42003 : GWP42004 | 1 | 12 | |
| other | Myocardial infarction | Cardiac disorders | GWP42003 and Placebo | 0 | 13 | |
| other | Myocardial infarction | Cardiac disorders | GWP42004 and Placebo | 0 | 12 | |
| other | Myocardial infarction | Cardiac disorders | Placebo | 0 | 14 | |
| other | Myocardial ischaemia | Cardiac disorders | 1:1 GWP42003 : GWP42004 | 0 | 11 | |
| other | Myocardial ischaemia | Cardiac disorders | 20:1 GWP42003 : GWP42004 | 0 | 12 | |
| other | Myocardial ischaemia | Cardiac disorders | GWP42003 and Placebo | 0 | 13 | |
| other | Myocardial ischaemia | Cardiac disorders | GWP42004 and Placebo | 0 | 12 | |
| other | Myocardial ischaemia | Cardiac disorders | Placebo | 1 | 14 |
1 to 10 of 395Source ClinicalTrials.gov
See all 395 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1:1 GWP42003 : GWP42004 | ||
| Total, all-cause mortality | 20:1 GWP42003 : GWP42004 | ||
| Total, all-cause mortality | GWP42003 and Placebo | ||
| Total, all-cause mortality | GWP42004 and Placebo | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 1:1 GWP42003 : GWP42004 | 7 | 11 |
| Total, other adverse events | 20:1 GWP42003 : GWP42004 | 8 | 12 |
| Total, other adverse events | GWP42003 and Placebo | 11 | 13 |
| Total, other adverse events | GWP42004 and Placebo | 11 | 12 |
| Total, other adverse events | Placebo | 13 | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27573936 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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