Trial Outcomes & Findings for Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes (NCT NCT00909480)
NCT ID: NCT00909480
Last Updated: 2017-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
457 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-03-10
Participant Flow
There were a total of 85 trial sites in 5 countries: 70 in the United States of America (USA), 5 in Thailand, 4 in Korea, 2 in India and 4 in Argentina
After randomisation, the dose and dosing frequency of metformin were maintained throughout the trial in both treatment arms. Other oral anti-diabetic drug (OAD) was discontinued before use of trial product
Participant milestones
| Measure |
IDet
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
229
|
|
Overall Study
Exposed
|
226
|
227
|
|
Overall Study
COMPLETED
|
190
|
188
|
|
Overall Study
NOT COMPLETED
|
38
|
41
|
Reasons for withdrawal
| Measure |
IDet
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Protocol Violation
|
6
|
8
|
|
Overall Study
Withdrawal criteria
|
9
|
11
|
|
Overall Study
Unclassified
|
18
|
19
|
Baseline Characteristics
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
56 participants
n=5 Participants
|
60 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
22 participants
n=5 Participants
|
31 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or pacific islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
138 participants
n=5 Participants
|
129 participants
n=7 Participants
|
267 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
51 participants
n=5 Participants
|
56 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
164 participants
n=5 Participants
|
150 participants
n=7 Participants
|
314 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Applicable
|
11 participants
n=5 Participants
|
21 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Weight
|
82.8 kg
STANDARD_DEVIATION 17.2 • n=5 Participants
|
81.7 kg
STANDARD_DEVIATION 16.2 • n=7 Participants
|
82.3 kg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.86 kg/m^2
STANDARD_DEVIATION 3.96 • n=5 Participants
|
29.06 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
28.96 kg/m^2
STANDARD_DEVIATION 3.93 • n=5 Participants
|
|
HbA1c (Glycosylated haemoglobin A1c)
|
7.96 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.62 • n=5 Participants
|
7.86 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.58 • n=7 Participants
|
7.91 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
8.66 mmol/L
STANDARD_DEVIATION 2.26 • n=5 Participants
|
8.46 mmol/L
STANDARD_DEVIATION 2.21 • n=7 Participants
|
8.56 mmol/L
STANDARD_DEVIATION 2.24 • n=5 Participants
|
|
Region of Enrolment
Argentina
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrolment
India
|
19 participants
n=5 Participants
|
32 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrolment
Korea, Republic of
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrolment
Thailand
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrolment
United States
|
163 participants
n=5 Participants
|
159 participants
n=7 Participants
|
322 participants
n=5 Participants
|
|
Height
|
1.69 meters
STANDARD_DEVIATION 0.11 • n=5 Participants
|
1.67 meters
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.68 meters
STANDARD_DEVIATION 0.11 • n=5 Participants
|
|
Stratification
Metformin+thiazolidinedione (TZD)
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Stratification
Metformin + other OAD other than TZD
|
149 participants
n=5 Participants
|
150 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Stratification
Metformin monotherapy
|
62 participants
n=5 Participants
|
62 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Diabetes History
|
7.99 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
8.44 years
STANDARD_DEVIATION 6.56 • n=7 Participants
|
8.22 years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=203 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Change in HbA1c From Baseline
|
-0.48 percentage point change
Standard Deviation 0.94
|
-0.74 percentage point change
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=204 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Metformin monotherapy
|
55 percentage of subjects
|
70 percentage of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Metformin+TZD
|
40 percentage of subjects
|
40 percentage of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Metformin+2nd OAD other than TZD
|
31 percentage of subjects
|
47 percentage of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
All
|
38 percentage of subjects
|
53 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=204 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
Metformin monotherapy
|
48 percentage (%) of subjects
|
52 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
Metformin+TZD
|
33 percentage (%) of subjects
|
33 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
Metformin+2nd OAD other than TZD
|
25 percentage (%) of subjects
|
33 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
All
|
32 percentage (%) of subjects
|
38 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=204 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Metformin monotherapy
|
22 percentage (%) of subjects
|
30 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Metformin+TZD
|
13 percentage (%) of subjects
|
13 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Metformin+2nd OAD other than TZD
|
5 percentage (%) of subjects
|
17 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
All
|
11 percentage (%) of subjects
|
21 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=204 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
Metformin monotherapy
|
22 percentage (%) of subjects
|
21 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
Metformin+TZD
|
7 percentage (%) of subjects
|
13 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
Metformin+2nd OAD other than TZD
|
3 percentage (%) of subjects
|
13 percentage (%) of subjects
|
|
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
All
|
9 percentage (%) of subjects
|
15 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
Outcome measures
| Measure |
IDet
n=209 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=209 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Fasting Plasma Glucose (FPG)
|
6.22 mmol/L
Standard Deviation 1.88
|
6.09 mmol/L
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
Metformin Monotherapy
|
0.48 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
0.67 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
|
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
Metformin+TZD
|
0.72 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
0.84 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
|
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
Metformin+2nd OAD other than TZD
|
0.6 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
0.71 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
|
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
Overall
|
0.57 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
0.71 mmol/L
Standard Deviation NA
The outcome 'within-subject variation' is defined as the sample standard-deviation of the non-missing pre-breakfast plasma-glucose values on three days before a visit, therefore no additional standard deviation of the standard is provided
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Before breakfast (N=200, N=197)
|
5.8 mmol/L
Standard Deviation 1.5
|
5.9 mmol/L
Standard Deviation 1.9
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
2 hours after breakfast (N=192, N=188)
|
9.1 mmol/L
Standard Deviation 2.9
|
8.7 mmol/L
Standard Deviation 2.8
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Before Lunch (N=193, N=189)
|
7.2 mmol/L
Standard Deviation 2.8
|
6.6 mmol/L
Standard Deviation 2.2
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
2 hours After Lunch (N=194, N=186)
|
9.7 mmol/L
Standard Deviation 3.2
|
8.8 mmol/L
Standard Deviation 2.9
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Before Dinner (N=194, N=186)
|
8.2 mmol/L
Standard Deviation 2.6
|
7.5 mmol/L
Standard Deviation 2.5
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
2 hours after dinner (N=192, N=190)
|
10.3 mmol/L
Standard Deviation 3
|
9.8 mmol/L
Standard Deviation 2.8
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Bedtime (N=190, N=183)
|
9.5 mmol/L
Standard Deviation 3.2
|
9 mmol/L
Standard Deviation 3.1
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
At 3AM (N=193, N=186)
|
6.6 mmol/L
Standard Deviation 2.5
|
6.3 mmol/L
Standard Deviation 2.1
|
|
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Before Breakfast Next Day (N=197, N=195)
|
5.7 mmol/L
Standard Deviation 1.7
|
5.6 mmol/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes During the Trial
All Events
|
329 episodes
|
457 episodes
|
|
Incidence of Hypoglycaemic Episodes During the Trial
Major
|
0 episodes
|
2 episodes
|
|
Incidence of Hypoglycaemic Episodes During the Trial
Minor
|
119 episodes
|
156 episodes
|
|
Incidence of Hypoglycaemic Episodes During the Trial
Symptoms only
|
210 episodes
|
299 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Hypoglycaemic Episodes, Diurnal
Major
|
0 episodes
|
2 episodes
|
|
Hypoglycaemic Episodes, Diurnal
Minor
|
75 episodes
|
118 episodes
|
|
Hypoglycaemic Episodes, Diurnal
Symptoms only
|
128 episodes
|
222 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Hypoglycaemic Episodes, Nocturnal
Major
|
0 episodes
|
0 episodes
|
|
Hypoglycaemic Episodes, Nocturnal
Minor
|
39 episodes
|
30 episodes
|
|
Hypoglycaemic Episodes, Nocturnal
Symptoms only
|
76 episodes
|
61 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Hypoglycemic Episodes, Unclassifiable
Major
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes, Unclassifiable
Minor
|
5 episodes
|
8 episodes
|
|
Hypoglycemic Episodes, Unclassifiable
Symptoms only
|
6 episodes
|
16 episodes
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
Outcome measures
| Measure |
IDet
n=196 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=193 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Change in Body Weight From Baseline
|
-0.49 kg
Standard Deviation 3.31
|
1 kg
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: Safety Analysis Set: All subjects that received at least one dose of the trial product.
Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications"
Outcome measures
| Measure |
IDet
n=226 Participants
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 Participants
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Number of Subjects Having the Adverse Event "Incorrect Dose Administered"
|
12 Subjects
|
24 Subjects
|
Adverse Events
IDet
Serious events: 7 serious events
Other events: 26 other events
Deaths: 0 deaths
IGlar
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDet
n=226 participants at risk
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 participants at risk
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
General disorders
Hernia
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.88%
2/226 • Number of events 2 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 2 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Infections and infestations
Ludwig Angina
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Infections and infestations
Meningitis
|
0.44%
1/226 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.00%
0/227 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Blood and lymphatic system disorders
Pneumonia
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/226 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
0.44%
1/227 • Number of events 1 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
Other adverse events
| Measure |
IDet
n=226 participants at risk
Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
|
IGlar
n=227 participants at risk
Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.6%
24/226 • Number of events 30 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
7.9%
18/227 • Number of events 22 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.0%
18/226 • Number of events 19 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
4.0%
9/227 • Number of events 11 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Infections and infestations
Influenza
|
4.9%
11/226 • Number of events 12 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
5.3%
12/227 • Number of events 12 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
16/226 • Number of events 19 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
4.4%
10/227 • Number of events 11 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
12/226 • Number of events 12 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
2.2%
5/227 • Number of events 5 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
|
Nervous system disorders
Headache
|
7.5%
17/226 • Number of events 40 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
7.5%
17/227 • Number of events 23 • Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right not to release data before passing specified milestones. This includes the right not to release interim results that may later be found to be incorrect. At the end of the trial, one or more manuscripts will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications but will reserve the right to postpone publication and/or communication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER