Efficacy and Safety of FIAsp Compared to Insulin Aspart i... | NCT01819129

NCT01819129

ID	Type	Description
2010-024051-93	EudraCT Number
U1111-1118-2509	Other Identifier	WHO
CTRI/2014/01/004285	Registry Identifier	Clinical Trials Registry - India (CTRI)

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Faster-acting insulin aspart (FIAsp)	Experimental	Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.	Drug: Faster-acting insulin aspart Drug: Insulin glargine
Insulin aspart	Active Comparator	Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.	Drug: Insulin aspart Drug: Insulin glargine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Faster-acting insulin aspart	Drug	Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.	Faster-acting insulin aspart (FIAsp)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c	The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.	Week 0, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in 2-hour PPG Increment (Meal Test)	For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.	Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Eligibility Module

Eligibility Criteria

Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Glendale	Arizona	85306-4652	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28483786	Result	Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.
29463670	Result

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily subcutaneous (sc) injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime self-measured plasma glucose (SMPG) on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
BG001	NovoRapid	At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.6± 9.3 BG00159.4± 9.6 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000182 BG001171 BG002

Glycosylated haemoglobin A1c (HbA1c)

Mean

Standard Deviation

Percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.96± 0.68 BG0017.89± 0.71 BG002

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00089.0± 16.9 BG00188.3± 16.7 BG002

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

Change From Baseline in HbA1c

The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation 'as randomized'.

Posted

Mean

Standard Deviation

Percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
OG001	NovoRapid	At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Units	Counts
Participants	OG000345 OG001344

Title

Denominators

Categories

Baseline (week 0)

Title	Measurements
	OG0007.96± 0.68 OG0017.89± 0.71

Week 26

Title	Measurements
	OG000

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	Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.					Mean Difference (Net)	-0.02			2-Sided	95	-0.15	0.10			The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).

Secondary

Change From Baseline in 2-hour PPG Increment (Meal Test)

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

This endpoint was summarized using the Full Analysis Set (FAS). FAS included all randomized subjects.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 26

ID	Title	Description
OG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
OG001	NovoRapid	At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Secondary

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.

This endpoint was summarized using the safety analysis set. Safety analysis set included all subjects receiving at least one dose of the test product or comparator. Subjects in the safety analysis set contributed to the evaluation 'as treated'.

Posted

Number

Number of episodes

From Week 0 to Week 26.

ID	Title	Description
OG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Secondary

Change From Baseline in Body Weight

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

This endpoint was summarized using the FAS. FAS included all randomized subjects.

Posted

Mean

Standard Deviation

Week 0, week 26

ID	Title	Description
OG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
OG001	NovoRapid	At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Faster Aspart	At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.			15	341	49	341
EG001	NovoRapid	At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.			24	341	53	341

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0011 events1 affected341 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Arteriogram coronary	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Aural polyp	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0012 events2 affected341 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0012 events2 affected341 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events2 affected341 at risk EG0015 events3 affected341 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0011 events1 affected341 at risk
Refractory anaemia with an excess of blasts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Renal cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0012 events2 affected341 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected341 at risk EG0010 events0 affected341 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected341 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected341 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00020 events17 affected341 at risk EG00127 events24 affected341 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00019 events16 affected341 at risk EG00127 events22 affected341 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00027 events20 affected341 at risk EG00116 events13 affected341 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

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