Research Study Comparing Insulin Degludec to Insulin Dete... | NCT03377699

ID	Type	Description	Link
U1111-1191-3018	Registry Identifier	World Health organization (WHO)
2017-000048-17	Registry Identifier	EudraCT

Label	Type	Description	Intervention Names
Insulin Degludec	Experimental	Insulin Degludec once daily and Insulin Aspart 2-4 times daily	Drug: Insulin degludec Drug: Insulin Aspart
Insulin Determir	Active Comparator	Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily	Drug: Insulin Aspart Drug: Insulin detemir

Name	Type	Description	Arm Group Labels	Other Names
Insulin degludec	Drug	Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months	Insulin Degludec

Measure	Description	Time Frame
Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery	Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.	From GW 16 to GW 36

Measure	Description	Time Frame
Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)	Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		CABA		C1180AAX	Argentina
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
36623517	Result	Mathiesen ER, Alibegovic AC, Corcoy R, Dunne F, Feig DS, Hod M, Jia T, Kalyanam B, Kar S, Kautzky-Willer A, Marchesini C, Rea RD, Damm P; EXPECT study group. Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open-label, multinational, randomised, controlled, non-inferiority trial. Lancet Diabetes Endocrinol. 2023 Feb;11(2):86-95. doi: 10.1016/S2213-8587(22)00307-2. Epub 2023 Jan 6.

ID	Title	Description
FG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 31, 2021	Dec 15, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery

Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.

FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Percentage glycosylated hemoglobin

From GW 16 to GW 36

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
OG001	IDet	Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Units	Counts
Participants	OG00084 OG00184

Title

Denominators

Categories

in-trial

- ParticipantsOG00084
- ParticipantsOG00184

Title	Measurements
	OG0006.30± 0.70

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
OG000 OG001	Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.	ANCOVA		<0.0001		Mean treatment difference	-0.11			2-Sided	95	-0.31	0.08					Non-Inferiority	Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.

Secondary

Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Count of Participants

Participants

From GW 16 to GW 36

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Count of Participants

Participants

From GW 16 to GW 36

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)

Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

mmol/L

From GW 16 to GW 36

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Last Planned Fasting Plasma Glucose Prior to Delivery

Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant which included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

mmol/L

From GW 16 to GW 36

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Hypoglycaemic Episodes During the Pregnancy Period

Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose <= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or > 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.

Posted

Number

Episodes

From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial

Posted

Count of Participants

Participants

From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.

Posted

Count of Participants

Participants

From treatment baseline (week 0) to end of treatment (28 days after delivery)

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Adverse Events During Pregnancy Period

Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.

Posted

Number

Events

From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)

Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.

Posted

Count of Participants

Participants

From GW 20 to delivery

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery

Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken > 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery

Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented.

SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Kilogram (Kg)

From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Birth Weight for Live Birth Infants

Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.

Posted

Mean

Standard Deviation

grams (g)

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Birth Weight Standard Deviation (SD) Score for Live Birth Infants

Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

Posted

Mean

Standard Deviation

Standard Deviation score

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)

Number of live born infants with birth weight <10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight <10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not <10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days).

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]

Number of live born infants with birth weight >90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight >90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not >90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days).

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Pre-term Delivery

Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in < 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact.

FASpregnant included all randomised women who were pregnant during the trial.

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)

Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant included all randomised women who were pregnant during the trial.

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)

Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and <1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days).

FASpregnant included all randomised women who were pregnant during the trial.

Posted

Count of Participants

Participants

Between at least 20 completed GWs before delivery and before 7 completed days after delivery

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)

Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and < 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Count of Participants

Participants

Between at least 7 completed days after delivery and before 28 completed days after delivery

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants

Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days).

FASpregnant included all randomised women who were pregnant during the trial.

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Participants With Live Born Infants (Yes/no)

Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Number of Adverse Events in the Infant

AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented.

Infants who were born to SASpregnant women are included. SASpregnant were randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.

Posted

Number

Events

From delivery to final follow-up 30 days after delivery

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Secondary

Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)

Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.

Posted

Count of Participants

Participants

During between 24 and 48 hours after birth

ID	Title	Description
OG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG0030 events0 affected94 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0003 events3 affected110 at risk EG0012 events2 affected112 at risk EG0020 events0 affected91 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Anaemia of pregnancy	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0012 events2 affected112 at risk EG0020 events0 affected91 at risk EG003
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0022 events2 affected91 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Blood glucose increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Blood ketone body increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Cervical incompetence	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Cholestasis of pregnancy	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0012 events2 affected112 at risk EG0020 events0 affected91 at risk EG003
Diabetes mellitus management	Surgical and medical procedures	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Foetal hypokinesia	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0002 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0003 events3 affected110 at risk EG0016 events6 affected112 at risk EG0020 events0 affected91 at risk EG003
Gestational oedema	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
HELLP syndrome	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0003 events3 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Haemorrhage in pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Headache	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hypertension	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0007 events4 affected110 at risk EG0017 events6 affected112 at risk EG0020 events0 affected91 at risk EG003
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Injection site hypersensitivity	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Macular oedema	Eye disorders	MedDRA 23	Systematic Assessment	EG0002 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Maternal therapy to enhance foetal lung maturity	Surgical and medical procedures	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Medical observation	Investigations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Medication error	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Placental insufficiency	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Polyhydramnios	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Postpartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0006 events6 affected110 at risk EG0012 events2 affected112 at risk EG0020 events0 affected91 at risk EG003
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Preterm premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Sciatica	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Shortened cervix	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Threatened labour	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0015 events4 affected112 at risk EG0020 events0 affected91 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Uterine contractions abnormal	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Uterine haematoma	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Uterine hypotonus	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk EG0020 events0 affected91 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
ABO haemolytic disease of newborn	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Ankyloglossia congenital	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0022 events2 affected91 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Cardiac murmur	Investigations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Cephalhaematoma	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Congenital naevus	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Congenital pneumonia	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Congenital pyelocaliectasis	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Dacryostenosis congenital	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
External auditory canal atresia	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Foetal distress syndrome	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0024 events4 affected91 at risk EG003
Fracture of clavicle due to birth trauma	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Haemangioma congenital	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Hypoglycaemia neonatal	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0025 events5 affected91 at risk EG003
Immature respiratory system	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Intraventricular haemorrhage neonatal	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Kidney duplex	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Lacrimal mucocoele	Eye disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Microtia	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Necrotising enterocolitis neonatal	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Neonatal asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Neonatal hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Neonatal respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Neonatal respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0029 events9 affected91 at risk EG003
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Neonatal tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Newborn persistent pulmonary hypertension	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Poor feeding infant	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Poor weight gain neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Premature baby	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0029 events9 affected91 at risk EG003
Pyelocaliectasis	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Sepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Sepsis neonatal	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0025 events5 affected91 at risk EG003
Shoulder dystocia	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Systemic bacterial infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Transient tachypnoea of the newborn	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0023 events3 affected91 at risk EG003
Unresponsive to stimuli	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Weight decrease neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Anencephaly	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Bladder agenesis	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Enteric duplication	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Foetal malformation	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0023 events1 affected91 at risk EG003
Oligohydramnios	Pregnancy, puerperium and perinatal conditions	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Polydactyly	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0021 events1 affected91 at risk EG003
Renal aplasia	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003
Ultrasound foetal abnormal	Investigations	MedDRA 23	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected112 at risk EG0020 events0 affected91 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C571886	insulin degludec
D061267	Insulin Aspart
D000069057	Insulin Detemir

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D049528	Insulin, Long-Acting

ID	Title	Description
BG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
BG001	IDet	Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IDeg	Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.	0	110	38	110	76	110
EG001	IDet	Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.	0	112	33	112	61	112
EG002	IDegInf	Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.	4	91	37	91	17	91
EG003	IDetInf	Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.	7	94	42	94	20	94