| Primary | Change in HbA1c (%) (Glycosylated Haemoglobin) | Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). | Here, 'number of subjects analysed' specifies the number of subjects, who contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Percentage (%) of HbA1c | | From week 0 to end of Ramadan (day 29 of Ramadan) | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. | | OG001 | Biphasic Insulin Aspart 30 | Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.11± 0.13
- OG001-1.13± 0.13
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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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| The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model. | Mixed model for repeated measurements | | 0.8426 | | Treatment Contrast | 0.02 | | | 2-Sided | 95 | -0.20 | 0.24 | | | | | Superiority or Other | | |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). | Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point. | Posted | | Mean | Standard Deviation | mmol/L | | From week 0 to end of Ramadan (day 29 of Ramadan) | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. | | OG001 | Biphasic Insulin Aspart 30 | Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan. |
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| Secondary | Change in Fructosamine | Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). | Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point. | Posted | | Mean | Standard Deviation | mmol/L | | From week 0 to end of Ramadan (day 29 of Ramadan) | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. | | OG001 | Biphasic Insulin Aspart 30 | Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan. |
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| Secondary | Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target ) | Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan). | Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point. | Posted | | Number | | Number of subjects | | End of Ramadan (day 29 of Ramadan) | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. | | OG001 | Biphasic Insulin Aspart 30 | |
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| Secondary | Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target) | Number of subjects who achieved FPG <=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG. | Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point. | Posted | | Number | | Number of subjects. | | End of Ramadan (day 29 of Ramadan) | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. | | OG001 | Biphasic Insulin Aspart 30 |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic | Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product. The above mentioned definitions (in endpoint title) should read as the following: Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL). Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure. | Analysis was based on the safety analysis set (SAS), which included all subjects receiving at least 1 dose of the investigational product (IDegAsp) or its comparator (BIAsp 30). | Posted | | Number | | Number of episodes. | | From week 0 to 4 weeks post Ramadan | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. |
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| Secondary | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive. Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. | Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator. | Posted | | Number | | Number of episodes. | | From week 0 to 4 weeks post Ramadan | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Insulin Aspart | Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan. |
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