parallel randomized trial
NCT03555994
An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo (part B) | metformin; lifestyle: not reported | 11 | ||
| A2 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg (part B) | metformin; lifestyle: not reported | 10 | ||
| A3 | Cotadutide 300 ug subcutaneous once daily Cotadutide 300 ug (part B) | metformin; lifestyle: not reported | 9 | ||
| A4 | Placebo Placebo (part A) | metformin; lifestyle: not reported | 9 | ||
| A5 | Cotadutide 300 ug subcutaneous once daily Cotadutide 300 ug (part A) | metformin; lifestyle: not reported | 12 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Liraglutide 1.8 mg subcutaneous once daily A2 | Cotadutide 300 ug subcutaneous once daily A3 | Placebo A4 | Cotadutide 300 ug subcutaneous once daily A5 |
|---|---|---|---|---|---|---|
| age | mean (years) | 64.0 | 65.2 | 61.8 | 69.3 | 65.8 |
| age | sd (years) | 10.7 | 9.1 | 7.5 | 5.7 | 7.3 |
| asian | n | 0 | 0 | 0 | 0 | 0 |
| bmi | mean (kg/m2) | 30.8 | 30.2 | 31.9 | 32.7 | 31.8 |
| bmi | sd (kg/m2) | 4.0 | 2.3 | 4.0 | 4.8 | 3.0 |
| egfr | mean (mL/min/1.73 m2) | 82.6 | 83.9 | 82.1 | 82.8 | 82.6 |
| egfr | sd (mL/min/1.73 m2) | 15.8 | 13.8 | 7.5 | 13.4 | 19.3 |
| female | n | 2 | 4 | 3 | 3 | 5 |
| white | n | 11 | 10 | 9 | 9 | 12 |
Analyses this trial contributes to
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
41 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 4 | A5 | change | -4.03 kg | -5.02 to -3.04 | 10 | not stated; modified itt; R0005744:Results | |
| 5 | A2 | change | -2.80 kg | -3.91 to -1.69 | 10 | not stated; modified itt; R0005744:Results | |
| 5 | A3 | change | -2.50 kg | -3.34 to -1.66 | 9 | not stated; modified itt; R0005744:Results |
Systolic blood pressure change (5 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 3.86 | A4 | change | 0.3 mmHg | 11.7 | 9 | not stated; other; R0005744:Supplementary Table 4 | |
| 3.86 | A5 | change | -8.2 mmHg | 11.7 | 10 | not stated; other; R0005744:Supplementary Table 4 | |
| 5 | A1 | change | -2.1 mmHg | 6.9 | 11 | not stated; other; R0005744:Extended Data Table 3 | |
| 5 | A2 | change | -8.4 mmHg | 17.7 | 10 | not stated; other; R0005744:Extended Data Table 3 | |
| 5 | A3 | change | -11.7 mmHg | 11.8 | 9 | not stated; other; R0005744:Extended Data Table 3 |
All cause mortality (5 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; R0005744:Table 2 | ||||
| A2 | events | 0 / 10 | not stated; safety; R0005744:Table 2 | ||||
| A3 | events | 0 / 9 | not stated; safety; R0005744:Table 2 | ||||
| A4 | events | 0 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 12 | not stated; safety; registry:adverse_events |
Serious adverse events (5 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; R0005744:Table 2 | ||||
| A2 | events | 0 / 10 | not stated; safety; R0005744:Table 2 | ||||
| A3 | events | 0 / 9 | not stated; safety; R0005744:Table 2 | ||||
| A4 | events | 0 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 12 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; R0005744:Table 2 | ||||
| A2 | events | 0 / 10 | not stated; safety; R0005744:Table 2 | ||||
| A3 | events | 0 / 9 | not stated; safety; R0005744:Table 2 |
Nausea (5 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; R0005744:Table 2 | ||||
| A2 | events | 1 / 10 | not stated; safety; R0005744:Table 2 | ||||
| A3 | events | 5 / 9 | not stated; safety; R0005744:Table 2 | ||||
| A4 | events | 2 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 8 / 12 | not stated; safety; registry:adverse_events |
Vomiting (5 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 10 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 9 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 5 / 12 | not stated; safety; registry:adverse_events |
Diarrhea (5 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 9 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 12 | not stated; safety; registry:adverse_events |
Constipation (5 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; R0005744:Table 2 | ||||
| A2 | events | 2 / 10 | not stated; safety; R0005744:Table 2 | ||||
| A3 | events | 2 / 9 | not stated; safety; R0005744:Table 2 | ||||
| A4 | events | 0 / 9 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 3 / 12 | not stated; safety; registry:adverse_events |