Trial Outcomes & Findings for Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment (NCT NCT00795600)
NCT ID: NCT00795600
Last Updated: 2016-03-16
Results Overview
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
COMPLETED
PHASE4
60 participants
week 0, week 26
2016-03-16
Participant Flow
Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.
Participant milestones
| Measure |
Insulin Detemir
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
35
|
|
Overall Study
Exposed to Drug
|
24
|
35
|
|
Overall Study
COMPLETED
|
21
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Insulin Detemir
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Unclassified
|
1
|
1
|
Baseline Characteristics
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Baseline characteristics by cohort
| Measure |
Insulin Detemir
n=24 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=35 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
60.63 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
63.74 years
STANDARD_DEVIATION 9.39 • n=7 Participants
|
62.47 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=5 Participants
|
35 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Duration of diabetes
|
13.58 years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
17.43 years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
15.86 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes)
Yes
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes)
No
|
20 participants
n=5 Participants
|
30 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes)
Yes
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes)
No
|
19 participants
n=5 Participants
|
28 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes)
Yes
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes)
No
|
13 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Diabetic complication at baseline, macroangiopathy
Yes
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Diabetic complication at baseline, macroangiopathy
No
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, week 26Population: Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
|
0.366 percent change
Standard Error 2.785
|
1.011 percent change
Standard Error 2.158
|
PRIMARY outcome
Timeframe: week 0, week 26Population: Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
|
0.535 percent change
Standard Error 2.875
|
1.126 percent change
Standard Error 2.212
|
PRIMARY outcome
Timeframe: week 0, week 26Population: ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Trunk Fat Mass
|
133.99 grams (g)
Standard Error 412.88
|
-62.37 grams (g)
Standard Error 320.00
|
PRIMARY outcome
Timeframe: week 0, week 26Population: Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Trunk Fat Mass
|
153.38 grams (g)
Standard Error 423.93
|
39.43 grams (g)
Standard Error 327.78
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.
Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Whole Body Fat Mass
|
1147.1 grams (g)
Standard Error 635.79
|
858.88 grams (g)
Standard Error 494.14
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.
Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Whole Body Fat Mass
|
3.870 percent change
Standard Error 2.267
|
4.047 percent change
Standard Error 1.762
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.
Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Whole Body Lean Mass
|
-54.20 grams (g)
Standard Error 673.32
|
1097.2 grams (g)
Standard Error 524.74
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.
Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Whole Body Lean Mass
|
0.051 percent change
Standard Error 1.485
|
2.798 percent change
Standard Error 1.158
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.
Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Trunk Lean Mass
|
359.43 grams (g)
Standard Error 306.47
|
469.84 grams (g)
Standard Error 238.67
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.
Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Trunk Lean Mass
|
1.480 percent change
Standard Error 1.381
|
2.090 percent change
Standard Error 1.076
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.
Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Calculated Whole Body Fat Percentage
|
0.782 percent of whole body fat (%)
Standard Error 0.578
|
0.291 percent of whole body fat (%)
Standard Error 0.450
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.
Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentual Change in Calculated Whole Body Fat Percentage
|
1.607 percent change
Standard Error 1.587
|
1.491 percent change
Standard Error 1.235
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.
Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Calculated Trunk Fat Percentage
|
-0.600 percent of trunk fat (%)
Standard Error 0.621
|
-0.321 percent of trunk fat (%)
Standard Error 0.483
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.
Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentual Change in Calculated Trunk Fat Percentage
|
-1.543 percent change
Standard Error 1.542
|
0.042 percent change
Standard Error 1.201
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.
Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Visceral Adipose Tissue Area
|
-3.258 cm^2
Standard Error 9.122
|
5.658 cm^2
Standard Error 7.042
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.
Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Visceral Adipose Tissue Area
|
-0.535 percent change
Standard Error 5.162
|
4.526 percent change
Standard Error 3.4985
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.
Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Subcutaneous Adipose Tissue Area
|
7.654 cm^2
Standard Error 10.764
|
12.616 cm^2
Standard Error 8.375
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.
Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Subcutaneous Adipose Tissue Area
|
1.153 percent change
Standard Error 3.952
|
5.743 percent change
Standard Error 3.075
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.
Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
|
-0.032 ratio
Standard Error 0.028
|
-0.036 ratio
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
|
-4.092 percent change
Standard Error 3.211
|
-3.303 percent change
Standard Error 2.493
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.
Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Liver/Spleen Attenuation Ratio
|
-0.044 ratio
Standard Error 0.035
|
-0.023 ratio
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.
Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Percentage Change in Liver/Spleen Attenuation Ratio
|
-2.632 percent change
Standard Error 3.102
|
-0.855 percent change
Standard Error 2.355
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.
Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in HbA1c (Glycosylated Haemoglobin)
|
-0.922 percentage of glycosylated haemoglobin
Standard Error 0.226
|
-0.792 percentage of glycosylated haemoglobin
Standard Error 0.172
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.
Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=29 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Fasting Plasma Glucose (FPG)
|
-48.29 mg/dL
Standard Error 14.599
|
-37.36 mg/dL
Standard Error 11.616
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.
Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=18 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Adiponectin
|
0.926 mcg/dL
Standard Error 3.605
|
2.844 mcg/dL
Standard Error 2.641
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Total Cholesterol
|
-8.96 mg/dL
Standard Deviation 57.60
|
7.77 mg/dL
Standard Deviation 31.47
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
|
-0.95 mg/dL
Standard Deviation 7.94
|
2.87 mg/dL
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
|
2.39 mg/dL
Standard Deviation 24.63
|
6.14 mg/dL
Standard Deviation 26.74
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=28 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
|
1.05 mg/dL
Standard Deviation 12.08
|
1.54 mg/dL
Standard Deviation 10.29
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=29 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Triglycerides
|
-14.71 mg/dL
Standard Deviation 57.60
|
-20.97 mg/dL
Standard Deviation 70.73
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Free Fatty Acids
|
-0.03 mg/dL
Standard Deviation 0.20
|
-0.05 mg/dL
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Haemoglobin
|
-0.38 g/dL
Standard Deviation 0.75
|
-0.35 g/dL
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Blood Volume (Haematocrit)
|
-1.17 percentage
Standard Deviation 2.49
|
-1.06 percentage
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=1 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Thrombocytes
|
0.10 percentage
Standard Deviation NA
No standard deviation calculated due to lack of available values at week 26
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Erythrocytes
|
4.64 percentage
Standard Deviation 0.58
|
4.38 percentage
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Leucocytes
|
-0.01 10^9 cells/L
Standard Deviation 1.68
|
-0.07 10^9 cells/L
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=1 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Lymphocytes
|
-0.10 percentage
Standard Deviation NA
No standard deviation calculated due to lack of available values at week 26
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=1 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Monocytes
|
0.10 percentage
Standard Deviation NA
No standard deviation calculated due to lack of available values at week 26
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=9 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=22 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Neutrophils
|
-0.29 percentage
Standard Deviation 1.32
|
0.01 percentage
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=9 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=22 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Eosinophils
|
0.01 10^9 cells/L
Standard Deviation 0.08
|
0.01 10^9 cells/L
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Outcome measures
| Measure |
Insulin Detemir
n=9 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=22 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Basophils
|
0.00 10^9 cells/L
Standard Deviation 0.10
|
-0.01 10^9 cells/L
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Creatinine
|
0.03 mg/dL
Standard Deviation 0.19
|
-0.00 mg/dL
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Creatine Phosphokinase
|
-19.86 IU/L
Standard Deviation 71.49
|
21.56 IU/L
Standard Deviation 50.11
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Urea
|
2.45 mg/dL
Standard Deviation 10.00
|
0.50 mg/dL
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=20 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Albumin
|
-0.02 mg/dL
Standard Deviation 0.40
|
0.01 mg/dL
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Bilirubin Total
|
-0.07 mg/dL
Standard Deviation 0.23
|
-0.07 mg/dL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Alanine Aminotransferase (ALAT)
|
-3.59 IU/L
Standard Deviation 8.43
|
-4.55 IU/L
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Aspartate Aminotransferase (ASAT)
|
0.23 IU/L
Standard Deviation 6.91
|
-0.48 IU/L
Standard Deviation 12.87
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Alkaline Phosphatase
|
-7.10 IU/L
Standard Deviation 18.61
|
-12.55 IU/L
Standard Deviation 57.55
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Sodium
|
1.12 mmol/L
Standard Deviation 3.81
|
0.69 mmol/L
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Potassium
|
-0.20 mmol/L
Standard Deviation 0.97
|
0.21 mmol/L
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.
Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.
Outcome measures
| Measure |
Insulin Detemir
n=23 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Body Weight
|
1.663 kg
Standard Error 0.779
|
2.293 kg
Standard Error 0.630
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.
Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=23 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Waist Circumference
|
0.064 cm
Standard Error 1.062
|
0.609 cm
Standard Error 0.832
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.
Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=23 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=32 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in Hip Circumference
|
0.577 cm
Standard Error 1.142
|
0.112 cm
Standard Error 0.905
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.
Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
|
1.200 mg/L
Standard Error 1.787
|
-0.862 mg/L
Standard Error 1.373
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.
Outcome measures
| Measure |
Insulin Detemir
n=18 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=31 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
|
-10.77 ng/L
Standard Error 5.119
|
-12.50 ng/L
Standard Error 3.765
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
Number of episodes reported during the trial.
Outcome measures
| Measure |
Insulin Detemir
n=24 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=35 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Number of Hypoglycaemic Episodes
|
17 episodes
|
32 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
Number of episodes reported during the trial.
Outcome measures
| Measure |
Insulin Detemir
n=24 Participants
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=35 Participants
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Number of Non-serious Adverse Events
|
64 events
|
103 events
|
Adverse Events
Insulin Detemir
Insulin NPH
Serious adverse events
| Measure |
Insulin Detemir
n=24 participants at risk
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=35 participants at risk
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
0.00%
0/35 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Injury, poisoning and procedural complications
Insulin aspart overdose
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Injury, poisoning and procedural complications
Crushed vertebra D-12
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
0.00%
0/35 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Nervous system disorders
White carotid ictus
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Cardiac disorders
Ischaemic cardiopathy
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
0.00%
0/35 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Skin and subcutaneous tissue disorders
Vascular ulcer worsening
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
Other adverse events
| Measure |
Insulin Detemir
n=24 participants at risk
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
Insulin NPH
n=35 participants at risk
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
2/24 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
0.00%
0/35 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
11.4%
4/35 • Number of events 4 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
General disorders
Pain
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
8.6%
3/35 • Number of events 4 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Infections and infestations
Ear infection
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Infections and infestations
Nasopharyngitis
|
29.2%
7/24 • Number of events 11 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
20.0%
7/35 • Number of events 9 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
8.6%
3/35 • Number of events 3 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 3 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
3/24 • Number of events 5 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
11.4%
4/35 • Number of events 10 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Number of events 5 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
20.0%
7/35 • Number of events 7 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER