Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
Interventions
DRUGinsulin detemir
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes (diagnosed more than 12 months ago) * HbA1c greater than 7.0 and less than 12.0% at screening * Currently on any OAD in more than 3 months ago * BMI (Body Mass Index) less than 35kg/m2
Exclusion criteria
* Previous treatment with insulin in more than 7 days within the last 3 months * Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | week 0, week 20 | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | week 0, week 12 | Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline |
| Change in Fasting Plasma Glucose (FPG) | week 0, week 12, week 20 | Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 |
| Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | week 12, week 20 | Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% |
| Occurence of Hypoglycaemic Episodes | weeks 0-20 | Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. |
Countries
South Korea
Participant flow
Recruitment details
A total of eight study sites in South Korea.
Pre-assignment details
Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).
Participants by arm
| Arm | Count |
|---|---|
| Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Well controlled FPG without insulin | 1 |
| Overall Study | Withdrawal | 1 |
Baseline characteristics
| Characteristic | Insulin Detemir |
|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 87 |
| serious Total, serious adverse events | 5 / 87 |
Outcome results
Primary
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20
Time frame: week 0, week 20
Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | HbA1c at baseline | 9.3 percentage change in HbA1c | Standard Deviation 1.1 |
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | HbA1c at week 20 | 8.2 percentage change in HbA1c | Standard Deviation 1.1 |
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | Change in HbA1c from baseline to week 20 | -1.2 percentage change in HbA1c | Standard Deviation 0.9 |
p-value: <0.000195% CI: [-1.368, -1.344]t-test
Secondary
Change in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20
Time frame: week 0, week 12, week 20
Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Change in Fasting Plasma Glucose (FPG) | FPG at baseline, N=81 | 178 mg/dL | Standard Deviation 54.2 |
| Insulin Detemir | Change in Fasting Plasma Glucose (FPG) | FPG at week 12, N=77 | 118 mg/dL | Standard Deviation 36.3 |
| Insulin Detemir | Change in Fasting Plasma Glucose (FPG) | FPG at week 20, N=78 | 116 mg/dL | Standard Deviation 35.8 |
| Insulin Detemir | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline to week 12, N=75 | -60 mg/dL | Standard Deviation 55.8 |
| Insulin Detemir | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline to week 20, N=73 | -62 mg/dL | Standard Deviation 61.5 |
Comparison: Estimated mean decrease in FPG at week 12p-value: <0.000195% CI: [-70.047, -69.06]Paired t-test
Comparison: Estimated mean decrease in FPG at week 20p-value: <0.000195% CI: [-72.647, -71.671]Paired t-test
Secondary
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline
Time frame: week 0, week 12
Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | HbA1c at week 12 | 8.2 percentage change in HbA1c | Standard Deviation 1.1 |
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | Change in HbA1c from baseline to week 12 | -1.2 percentage change in HbA1c | Standard Deviation 0.9 |
| Insulin Detemir | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | HbA1c at baseline | 9.3 percentage change in HbA1c | Standard Deviation 1.1 |
p-value: <0.000195% CI: [-1.35, -1.327]t-test
Secondary
Occurence of Hypoglycaemic Episodes
Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.
Time frame: weeks 0-20
Population: For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Detemir | Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes: Diurnal | 92 episodes |
| Insulin Detemir | Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes: Nocturnal | 78 episodes |
| Insulin Detemir | Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes: Total | 170 episodes |
Secondary
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%
Time frame: week 12, week 20
Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Detemir | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Not achieving HbA1c < 7% after 12 weeks, N=82 | 85.4 percentage of participants |
| Insulin Detemir | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Achieving HbA1c < 7% after 12 weeks, N=82 | 14.6 percentage of participants |
| Insulin Detemir | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Achieving HbA1c < 7% after 20 weeks, N=81 | 12.3 percentage of participants |
| Insulin Detemir | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Not achieving HbA1c < 7% after 20 weeks, N=81 | 87.7 percentage of participants |