Trial Outcomes & Findings for A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before (NCT NCT04760626)

NCT ID: NCT04760626

Last Updated: 2025-09-03

Results Overview

Change in HbA1c from baseline (week 0) to week 52 is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1085 participants

Primary outcome timeframe

Baseline (week 0), week 52

Results posted on

2025-09-03

Participant Flow

The trial was conducted at 182 sites in Canada, Germany, Greece, Hungary, Poland, Turkey and the United States.

Participant milestones

Participant milestones
Measure	Insulin Icodec Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Overall Study STARTED	542	543
Overall Study Full Analysis Set (FAS)	542	543
Overall Study Safety Analysis Set (SAS)	542	538
Overall Study COMPLETED	497	493
Overall Study NOT COMPLETED	45	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin Icodec Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Overall Study Withdrawal by Subject	24	20
Overall Study Lost to Follow-up	14	19
Overall Study Physician Decision	3	5
Overall Study Death	3	6
Overall Study Site closure	1	0

Baseline Characteristics

A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=543 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.	Total n=1085 Participants Total of all reporting groups
Age, Continuous	59.15 Years STANDARD_DEVIATION 10.79 • n=99 Participants	59.39 Years STANDARD_DEVIATION 10.15 • n=107 Participants	59.27 Years STANDARD_DEVIATION 10.47 • n=206 Participants
Sex: Female, Male Female	233 Participants n=99 Participants	230 Participants n=107 Participants	463 Participants n=206 Participants
Sex: Female, Male Male	309 Participants n=99 Participants	313 Participants n=107 Participants	622 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	51 Participants n=99 Participants	44 Participants n=107 Participants	95 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	490 Participants n=99 Participants	499 Participants n=107 Participants	989 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Asian	28 Participants n=99 Participants	19 Participants n=107 Participants	47 Participants n=206 Participants
Race/Ethnicity, Customized Black Or African American	24 Participants n=99 Participants	28 Participants n=107 Participants	52 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized White	478 Participants n=99 Participants	493 Participants n=107 Participants	971 Participants n=206 Participants
Race/Ethnicity, Customized Other	7 Participants n=99 Participants	1 Participants n=107 Participants	8 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in HbA1c from baseline (week 0) to week 52 is presented.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=542 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Change in Glycated Haemoglobin (HbA1c)	-1.68 Percentage of HbA1c Standard Error 0.09	-1.31 Percentage of HbA1c Standard Error 0.12

SECONDARY outcome

Timeframe: From baseline (week 0) to week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=59 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=50 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Time From Baseline to Treatment Discontinuation or Intensification	20.1 Weeks Interval 0.0 to 51.0	13.9 Weeks Interval 0.0 to 55.1

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in DTSQs in total treatment satisfaction is presented. The DTSQs questionnaire was used to assess participants treatment satisfaction which contained 8 components (DTSQs Item 1-8 : how satisfied are you with your current treatment, how often have you felt that blood sugars have been unacceptably high, how often have you felt that blood sugars have been unacceptably low, how convenient have you been finding your treatment to be recently, how flexible have you been finding your treatment to be recently, how satisfied are you with your understanding of your diabetes, would you recommend treatment to someone else with your kind of diabetes, how satisfied would you be to continue with present form of treatment). The result presented is the treatment satisfaction summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Total scores for treatment satisfaction range from 0-36 with 0 being the lowest and 36 being the highest score in total treatment satisfaction.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=513 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=500 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction	4.68 Score on a scale Standard Error 0.25	3.90 Score on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: At end of treatment (week 52)

Population: FAS included all randomised subjects.

Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance domain at week 52 is presented. The TRIM-D questionnaire was developed to capture the impact of diabetes treatment on patients' functioning and well-being. The questionnaire was used to measure the compliance between the treatment groups. The total TRIM-D compliance score is computed by summing across the items and then transforming to a 0-100 scale with higher score indicating better compliance.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=543 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain	90.42 Score on a scale Standard Error 0.64	87.37 Score on a scale Standard Error 0.64

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed = participants with available data for this outcome measure.

Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=538 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Number of Severe Hypoglycaemic Episodes (Level 3)	0 Episodes	5 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 millimoles per liter \[mmol/L\] (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=538 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 Millimoles Per Liter [mmol/L] (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter)	104 Episodes	76 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.

Outcome measures

Outcome measures
Measure	Insulin Icodec n=542 Participants Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=538 Participants Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)	104 Episodes	81 Episodes

Adverse Events

Insulin Icodec

Serious events: 45 serious events

Other events: 43 other events

Deaths: 3 deaths

Once Daily Basal Insulin Analogue

Serious events: 57 serious events

Other events: 55 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Insulin Icodec n=542 participants at risk Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (\<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (\>) 7.2 mmol/L: dose increased by 20 U.	Once Daily Basal Insulin Analogue n=538 participants at risk Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
Infections and infestations COVID-19	7.9% 43/542 • Number of events 46 • From baseline week 0 to week 57 All presented AEs are treatment emergent. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all randomised participants randomly assigned to trial treatment who took at least 1 dose of trial product. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	10.2% 55/538 • Number of events 57 • From baseline week 0 to week 57 All presented AEs are treatment emergent. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all randomised participants randomly assigned to trial treatment who took at least 1 dose of trial product. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER