| Primary | Glycosylated Haemoglobin (HbA1c) | Estimated mean difference in HbA1c after 50 weeks of treatment | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing. | Posted | | Mean | Standard Error | percentage of glycosylated haemoglobin | | Week 50 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0007.34± 0.13
- OG0017.23± 0.12
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated. | ANCOVA | | 0.3406 | | Mean Difference (Final Values) | 0.11 | | | | 95 | -0.12 | 0.34 | | | | Yes | Non-Inferiority or Equivalence | The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 <0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens. |
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| Secondary | Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment | Observed mean change from baseline in HbA1c at Week 14 (visit 11) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing. | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 14 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment | Observed mean change in from baseline in HbA1c at Week 26 (visit 18) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing. | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 26 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment | Observed mean change from baseline in HbA1c at Week 38 (visit 25) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing. | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Change in Glycosylated Haemoglobin (HbA1c) at Week 50 | Observed mean change from baseline in HbA1c at Week 50 (visit 32) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing. | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment | Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11) | Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing. | Posted | | Number | | Subjects | | Week 14 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment | Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18) | Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing. | Posted | | Number | | Subjects | | Week 26 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment | Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25) | Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing. | Posted | | Number | | Subjects | | Week 38 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment | Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32) | Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing. | Posted | | Number | | Subjects | | Week 50 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment | Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations. | Posted | | Mean | Standard Deviation | mg/dL | | Week 14 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment | Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations. | Posted | | Mean | Standard Deviation | mg/dL | | Week 26 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment | Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations. | Posted | | Mean | Standard Deviation | mg/dL | | Week 38 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment | Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations. | Posted | | Mean | Standard Deviation | mg/dL | | Week 50 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment | Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | mg/dL | | Week 14 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment | Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | mg/dL | | Week 26 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment | Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | mg/dL | | Week 38 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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| Secondary | Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment | Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32) | Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | mg/dL | | Week 50 | | | | ID | Title | Description |
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| OG000 | Detemir + Met | Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached. | | OG001 | BIAsp 30 + Met | Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached. |
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