Trial · NCT03689374

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

NCT03689374, Phase 3, Completed, Novo Nordisk A/S; results first posted 2022-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes. Trials, record NCT03689374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03689374

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
NCT number: NCT03689374
Status: Completed
Phases: Phase 3
Enrollment: 2,274 participants, actual
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: Semaglutide, Insulin aspart, Insulin glargine U100
First posted: 2018-09-28
Last updated: 2022-11-14
Other registries' IDs: eudract:2017-003219-20
Results first posted: 2022-05-04

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Glycated Haemoglobin (HbA1c)	Baseline (week 0), week 52	Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52	From randomization (week 0) up to week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52	From randomization (week 0) up to week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52	From randomization (week 0) to week 52	Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration \<= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52	From randomization (week 0) to week 52	Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose \< 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose \< 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Daily Basal Insulin Dose at Week 52	At week 52	Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Secondary	Total Daily Insulin Dose at Week 52	At week 52	Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Glycated Haemoglobin (HbA1c)	Baseline (week 0), week 52	Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.	Percentage of HbA1c	MEAN
SECONDARY	Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52	From randomization (week 0) up to week 52	Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.	First event per 100 years of exposure	NUMBER
SECONDARY	Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52	From randomization (week 0) up to week 52	Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.	First event per 100 years of exposure	NUMBER
SECONDARY	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52	From randomization (week 0) to week 52	Full analysis set included all randomized participants.	Episodes	NUMBER
SECONDARY	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Full analysis set included all randomized participants.	Episodes	NUMBER
SECONDARY	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Full analysis set included all randomized participants.	Episodes	NUMBER
SECONDARY	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52	From randomization (week 0) to week 52	Full analysis set included all randomized participants.	Episodes	NUMBER
SECONDARY	Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52	From randomization (week 0) to week 52	Full analysis set included all randomized participants.	Episodes	NUMBER
SECONDARY	Daily Basal Insulin Dose at Week 52	At week 52	Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.	Units of insulin	MEAN
SECONDARY	Total Daily Insulin Dose at Week 52	At week 52	Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.	Units of insulin	MEAN

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Glycated Haemoglobin (HbA1c)	Semaglutide	-1.5	Standard Deviation 1.0	Percentage of HbA1c
Change From Baseline in Glycated Haemoglobin (HbA1c)	Insulin Aspart	-1.2	Standard Deviation 1.0	Percentage of HbA1c
Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52	Semaglutide	0.4		First event per 100 years of exposure
Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52	Insulin Aspart	0.7		First event per 100 years of exposure
Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52	Semaglutide	0.2		First event per 100 years of exposure
Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52	Insulin Aspart	0.4		First event per 100 years of exposure
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52	Semaglutide	4		Episodes
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52	Insulin Aspart	7		Episodes
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52	Semaglutide	254		Episodes
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52	Insulin Aspart	1744		Episodes

1 to 10 of 84Source ClinicalTrials.gov

See all 84 results by group

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-in Period (12 Weeks)	STARTED	All Participants	2,274
Run-in Period (12 Weeks)	STARTED	Semaglutide	0
Run-in Period (12 Weeks)	STARTED	Insulin Aspart	0
Run-in Period (12 Weeks)	COMPLETED	All Participants	1,748
Run-in Period (12 Weeks)	COMPLETED	Semaglutide	0
Run-in Period (12 Weeks)	COMPLETED	Insulin Aspart	0
Run-in Period (12 Weeks)	NOT COMPLETED	All Participants	526
Run-in Period (12 Weeks)	NOT COMPLETED	Semaglutide	0
Run-in Period (12 Weeks)	NOT COMPLETED	Insulin Aspart	0
Treatment Period (Week 0 to 52)	STARTED	All Participants	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events316

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Semaglutide	65	874	98
other	Diarrhoea	Gastrointestinal disorders	Insulin Aspart	23	864	29
other	Nasopharyngitis	Infections and infestations	Semaglutide	57	874	69
other	Nasopharyngitis	Infections and infestations	Insulin Aspart	51	864	73
other	Nausea	Gastrointestinal disorders	Semaglutide	129	874	174
other	Nausea	Gastrointestinal disorders	Insulin Aspart	7	864	7
other	Vomiting	Gastrointestinal disorders	Semaglutide	50	874	78
other	Vomiting	Gastrointestinal disorders	Insulin Aspart	5	864	6
serious	Abdominal hernia	Gastrointestinal disorders	Semaglutide	1	874	1
serious	Abdominal hernia	Gastrointestinal disorders	Insulin Aspart	0	864	0

1 to 10 of 316Source ClinicalTrials.gov

See all 316 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Semaglutide	12	874
Total, all-cause mortality	Insulin Aspart	1	864
Total, other adverse events	Semaglutide	225	874
Total, other adverse events	Insulin Aspart	65	864
Total, serious adverse events	Semaglutide	65	874
Total, serious adverse events	Insulin Aspart	84	864

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35546450	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Semaglutide vs Insulin Aspart: deaths from any cause	Trial comparisons
Semaglutide vs Insulin Aspart: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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