Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions. Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age according to approved label in each country and physician discretion * Type 1 or 2 diabetes * Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin * Selection at the discretion of the physician
Exclusion criteria
* Current treatment with Levemir® (insulin detemir) * Previously enrolled in the study * Hypersensitivity to Levemir® (insulin detemir)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Months 0-12 | The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. |
Countries
Belgium, Czechia, Denmark, Finland, France, Greece, Ireland, Israel, Italy, South Korea, Sweden, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Study conducted globally in 26 countries. Some countries participated for only 3 months, while others extended their participation to 6 and 12 months, respectively.
Pre-assignment details
Subjects with type 1 or type 2 diabetes including newly diagnosed subjects who had never received insulin or an insulin analogue at the prescribing physician's discretion.
Participants by arm
| Arm | Count |
|---|---|
| Type 1 Diabetes Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. | 13,529 |
| Type 2 Diabetes Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. | 37,641 |
| Total | 51,170 |
Baseline characteristics
| Characteristic | Type 1 Diabetes | Total | Type 2 Diabetes |
|---|---|---|---|
| Age, Continuous Austria, n=331, 430 | 41.9 years STANDARD_DEVIATION 13.8 | 52.6 years STANDARD_DEVIATION 12.5 | 60.8 years STANDARD_DEVIATION 11.5 |
| Age, Continuous Belgium/Luxembourg, n=330, 38 | 45.2 years STANDARD_DEVIATION 15.4 | 47.0 years STANDARD_DEVIATION 14.8 | 62.4 years STANDARD_DEVIATION 9.6 |
| Age, Continuous Brazil, n=962, 1136 | 29.6 years STANDARD_DEVIATION 15.5 | 46.2 years STANDARD_DEVIATION 14.1 | 60.3 years STANDARD_DEVIATION 12.9 |
| Age, Continuous Czech Republic, n=861, 820 | 45.3 years STANDARD_DEVIATION 16.8 | 52.2 years STANDARD_DEVIATION 13.8 | 59.4 years STANDARD_DEVIATION 10.7 |
| Age, Continuous Denmark, n=312, 77 | 45.6 years STANDARD_DEVIATION 13.3 | 48.7 years STANDARD_DEVIATION 12.8 | 61.4 years STANDARD_DEVIATION 10.9 |
| Age, Continuous Finland, n=809, 249 | 41.9 years STANDARD_DEVIATION 14.3 | 45.9 years STANDARD_DEVIATION 13.5 | 58.8 years STANDARD_DEVIATION 10.7 |
| Age, Continuous France, n=641, 1127 | 47.1 years STANDARD_DEVIATION 16.1 | 57.0 years STANDARD_DEVIATION 13.4 | 62.6 years STANDARD_DEVIATION 11.9 |
| Age, Continuous Germany, n=2640, 7526 | 45.0 years STANDARD_DEVIATION 15.7 | 57.8 years STANDARD_DEVIATION 11.8 | 62.3 years STANDARD_DEVIATION 10.4 |
| Age, Continuous Greece, n=125, 923 | 31.6 years STANDARD_DEVIATION 16.3 | 60.9 years STANDARD_DEVIATION 11.8 | 64.9 years STANDARD_DEVIATION 11.2 |
| Age, Continuous India, n=142, 3162 | 31.4 years STANDARD_DEVIATION 17 | 51.7 years STANDARD_DEVIATION 10.4 | 52.6 years STANDARD_DEVIATION 10.1 |
| Age, Continuous Israel, n=295, 722 | 36.5 years STANDARD_DEVIATION 20 | 53.3 years STANDARD_DEVIATION 13.7 | 60.2 years STANDARD_DEVIATION 11.1 |
| Age, Continuous Italy, n=177, 1297 | 44.6 years STANDARD_DEVIATION 16 | 62.5 years STANDARD_DEVIATION 11.5 | 64.9 years STANDARD_DEVIATION 9.8 |
| Age, Continuous Japan, n=490, 2801 | 50.5 years STANDARD_DEVIATION 16.1 | 60.2 years STANDARD_DEVIATION 13.3 | 61.9 years STANDARD_DEVIATION 12.8 |
| Age, Continuous Lebanon, n=63, 192 | 27.6 years STANDARD_DEVIATION 10.3 | 50.6 years STANDARD_DEVIATION 11.3 | 58.2 years STANDARD_DEVIATION 11.6 |
| Age, Continuous Netherlands, n=92, 324 | 39.9 years STANDARD_DEVIATION 16.6 | 55.3 years STANDARD_DEVIATION 13.8 | 59.7 years STANDARD_DEVIATION 13 |
| Age, Continuous Russia, n=1121, 2515 | 28.5 years STANDARD_DEVIATION 15.8 | 49.4 years STANDARD_DEVIATION 11.6 | 58.7 years STANDARD_DEVIATION 9.8 |
| Age, Continuous Saudi Arabia, n=104, 503 | 25.0 years STANDARD_DEVIATION 13.1 | 45.7 years STANDARD_DEVIATION 10.9 | 50.0 years STANDARD_DEVIATION 10.5 |
| Age, Continuous Slovenia, n=91, 209 | 42.3 years STANDARD_DEVIATION 14.5 | 54.0 years STANDARD_DEVIATION 11.4 | 59.1 years STANDARD_DEVIATION 10 |
| Age, Continuous South Africa, n=207, 247 | 33.6 years STANDARD_DEVIATION 16 | 44.3 years STANDARD_DEVIATION 13.8 | 53.3 years STANDARD_DEVIATION 11.9 |
| Age, Continuous South Korea, n=224, 8854 | 36.0 years STANDARD_DEVIATION 16 | 56.4 years STANDARD_DEVIATION 12.5 | 56.9 years STANDARD_DEVIATION 12.4 |
| Age, Continuous Sweden, n=553, 95 | 42.0 years STANDARD_DEVIATION 17.5 | 44.8 years STANDARD_DEVIATION 16.6 | 61.3 years STANDARD_DEVIATION 11.2 |
| Age, Continuous Tunisia, n=21, 316 | 24.5 years STANDARD_DEVIATION 15.9 | 55.5 years STANDARD_DEVIATION 11.4 | 57.6 years STANDARD_DEVIATION 11.1 |
| Age, Continuous Turkey, n=622, 2132 | 28.9 years STANDARD_DEVIATION 15.2 | 49.8 years STANDARD_DEVIATION 11.6 | 55.9 years STANDARD_DEVIATION 10.5 |
| Age, Continuous United Kingdom/Ireland, n=2292, 1832 | 35.5 years STANDARD_DEVIATION 17.6 | 46.0 years STANDARD_DEVIATION 15 | 59.2 years STANDARD_DEVIATION 11.7 |
| Duration of diabetes (12 months' participation) Finland, n=796, 245 | 19.8 years STANDARD_DEVIATION 12.3 | 18.3 years STANDARD_DEVIATION 11.2 | 13.3 years STANDARD_DEVIATION 7.6 |
| Duration of diabetes (12 months' participation) France, n=628, 1117 | 17 years STANDARD_DEVIATION 12 | 15.5 years STANDARD_DEVIATION 10 | 14.6 years STANDARD_DEVIATION 8.9 |
| Duration of diabetes (12 months' participation) Japan, n=420, 2240 | 12.1 years STANDARD_DEVIATION 10 | 13.9 years STANDARD_DEVIATION 9.1 | 14.2 years STANDARD_DEVIATION 8.9 |
| Duration of diabetes (3 months' participation) Austria, n=330, 428 | 18.5 years STANDARD_DEVIATION 13.6 | 15.1 years STANDARD_DEVIATION 10.7 | 12.5 years STANDARD_DEVIATION 8.5 |
| Duration of diabetes (3 months' participation) Brazil, n=959, 1141 | 12.6 years STANDARD_DEVIATION 9.7 | 13.2 years STANDARD_DEVIATION 9.3 | 13.7 years STANDARD_DEVIATION 9 |
| Duration of diabetes (3 months' participation) Denmark, n=312, 76 | 20.4 years STANDARD_DEVIATION 12.6 | 18.7 years STANDARD_DEVIATION 11.4 | 11.8 years STANDARD_DEVIATION 6.6 |
| Duration of diabetes (3 months' participation) Germany, n=2607, 7468 | 17.2 years STANDARD_DEVIATION 12.5 | 12.3 years STANDARD_DEVIATION 8.6 | 10.6 years STANDARD_DEVIATION 7.2 |
| Duration of diabetes (3 months' participation) Israel, n=286, 721 | 14.3 years STANDARD_DEVIATION 12.4 | 15.3 years STANDARD_DEVIATION 10 | 15.7 years STANDARD_DEVIATION 9.1 |
| Duration of diabetes (3 months' participation) Lebanon, n=63, 192 | 11.4 years STANDARD_DEVIATION 7.7 | 12.0 years STANDARD_DEVIATION 7.2 | 12.2 years STANDARD_DEVIATION 7.1 |
| Duration of diabetes (3 months' participation) Russia, n=1112, 2509 | 8.5 years STANDARD_DEVIATION 8.2 | 9.2 years STANDARD_DEVIATION 6.5 | 9.5 years STANDARD_DEVIATION 5.8 |
| Duration of diabetes (3 months' participation) Slovenia, n=90, 208 | 18.1 years STANDARD_DEVIATION 13 | 15.0 years STANDARD_DEVIATION 9.5 | 13.7 years STANDARD_DEVIATION 8 |
| Duration of diabetes (3 months' participation) Turkey, n=612, 2127 | 8.2 years STANDARD_DEVIATION 6.7 | 10.1 years STANDARD_DEVIATION 6.6 | 10.6 years STANDARD_DEVIATION 6.6 |
| Duration of diabetes (6 months' participation) Belgium/Luxembourg, n=329, 38 | 17.7 years STANDARD_DEVIATION 12.3 | 17.3 years STANDARD_DEVIATION 12 | 14.0 years STANDARD_DEVIATION 9.2 |
| Duration of diabetes (6 months' participation) Czech Republic, n=856, 807 | 14.5 years STANDARD_DEVIATION 11.1 | 13.7 years STANDARD_DEVIATION 9.5 | 12.8 years STANDARD_DEVIATION 7.8 |
| Duration of diabetes (6 months' participation) Greece, n=129, 956 | 11.9 years STANDARD_DEVIATION 9.9 | 13.2 years STANDARD_DEVIATION 7.9 | 13.4 years STANDARD_DEVIATION 7.6 |
| Duration of diabetes (6 months' participation) India, n=139, 3178 | 6.6 years STANDARD_DEVIATION 6.2 | 8.4 years STANDARD_DEVIATION 5.5 | 8.5 years STANDARD_DEVIATION 5.5 |
| Duration of diabetes (6 months' participation) Italy, n=175, 1292 | 14.6 years STANDARD_DEVIATION 11.6 | 14.7 years STANDARD_DEVIATION 9 | 14.7 years STANDARD_DEVIATION 8.6 |
| Duration of diabetes (6 months' participation) Netherlands, n=88, 318 | 16.0 years STANDARD_DEVIATION 14.5 | 11.0 years STANDARD_DEVIATION 8.5 | 9.6 years STANDARD_DEVIATION 6.9 |
| Duration of diabetes (6 months' participation) Saudi Arabia, n=96, 494 | 7.2 years STANDARD_DEVIATION 6.3 | 8.8 years STANDARD_DEVIATION 5.7 | 9.1 years STANDARD_DEVIATION 5.6 |
| Duration of diabetes (6 months' participation) South Africa, n=196, 243 | 11.3 years STANDARD_DEVIATION 9.4 | 10.5 years STANDARD_DEVIATION 8.3 | 9.9 years STANDARD_DEVIATION 7.4 |
| Duration of diabetes (6 months' participation) South Korea, n=214, 8701 | 9.4 years STANDARD_DEVIATION 7.7 | 10.1 years STANDARD_DEVIATION 6.8 | 10.1 years STANDARD_DEVIATION 6.8 |
| Duration of diabetes (6 months' participation) Sweden, n=547, 96 | 19.6 years STANDARD_DEVIATION 14.2 | 18.7 years STANDARD_DEVIATION 13.2 | 13.6 years STANDARD_DEVIATION 7.4 |
| Duration of diabetes (6 months' participation) Tunisia, n=21, 316 | 8.2 years STANDARD_DEVIATION 7.7 | 11.3 years STANDARD_DEVIATION 6.5 | 11.5 years STANDARD_DEVIATION 6.4 |
| Duration of diabetes (6 months' participation) United Kingdom/Ireland, n=2260, 1827 | 15.2 years STANDARD_DEVIATION 12.3 | 13.5 years STANDARD_DEVIATION 10.2 | 11.3 years STANDARD_DEVIATION 7.7 |
| Sex/Gender, Customized Female | 6865 participants | 26040 participants | 19175 participants |
| Sex/Gender, Customized Male | 6658 participants | 25111 participants | 18453 participants |
| Sex/Gender, Customized Not specified | 6 participants | 19 participants | 13 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13,529 | 0 / 37,641 |
| serious Total, serious adverse events | 130 / 13,529 | 80 / 37,641 |
Outcome results
Primary
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.
Time frame: Months 0-12
Population: FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 1 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 3 months sub-group | 186 participants |
| Type 1 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 6 months sub-group | 208 participants |
| Type 1 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 12 months sub-group | 109 participants |
| Type 2 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 3 months sub-group | 93 participants |
| Type 2 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 6 months sub-group | 112 participants |
| Type 2 Diabetes | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | 12 months sub-group | 48 participants |