| Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS). | Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements. | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, week 20 | | | | ID | Title | Description |
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| OG000 | Subject-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. | | OG001 | Investigator-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.32± 0.86
- OG001-1.31± 0.96
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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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| | Regression, Linear | | | | Mean Difference (Final Values) | -0.02 | Standard Deviation | 0.08 | | 95 | -0.19 | 0.14 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%. | |
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| Secondary | Percentage of Subjects Achieving HbA1c Below 7.0% | | Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. | Posted | | Number | | percentage (%) of subjects | | After 20 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Subject-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. | | OG001 | Investigator-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. |
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| Secondary | Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | | Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. | Posted | | Number | | percentage (%) of subjects | | After 20 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Subject-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. | | OG001 | Investigator-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. |
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| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) | | Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 20 | | | | ID | Title | Description |
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| OG000 | Subject-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. | | OG001 | Investigator-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. |
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| Secondary | Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) | Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms. | Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30. | Posted | | Number | | events per patient per year | | Week 0 to week 20 (inclusive). | | | | ID | Title | Description |
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| OG000 | Subject-driven Titration | Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels. | | OG001 | Investigator-driven Titration | |
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