Comparison of Two Basal Insulins for Patients With Type 2... | NCT00494013

NCT00494013

ID	Type	Description	Link
F3Z-MC-IOOY

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
Insulin Lispro Protamine Suspension	Experimental	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.	Drug: Insulin Lispro Protamine Suspension
Detemir	Active Comparator	Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.	Drug: Detemir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Lispro Protamine Suspension	Drug	Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.	Insulin Lispro Protamine Suspension

Outcomes Module

Measure	Description	Time Frame
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)		Baseline, 24 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks		Baseline, 12 Weeks, 24 Weeks
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint	Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have type 2 diabetes mellitus for at least 1 year.
Are at least 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Hueytown	Alabama	35023

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23101951	Derived	Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
20546262	Derived	Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
FG001	Detemir

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
BG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
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 Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.32± 9.91 BG00155.73± 10.20 BG00256.03± 10.04

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000108 BG00197 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00010 BG00111 BG002

Race/Ethnicity

Number

participants

Title

Denominators

Categories

African

Title	Measurements
	BG0008 BG0018 BG002

Sulfonylurea Group

Patients with previous sulfonylurea use.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000170 BG001158 BG002

Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared.

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00030.03± 5.01 BG00130.10± 5.12

Body Weight

Mean

Standard Deviation

kilograms (kg)

Title

Denominators

Categories

Title	Measurements
	BG00081.10± 17.46 BG00182.72± 19.32 BG002

Duration of Diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.48± 6.09 BG0018.94± 5.59 BG002

Height

Mean

Standard Deviation

centimeters (cm)

Title

Denominators

Categories

Title	Measurements
	BG000163.94± 10.19 BG001165.14± 10.94 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 to 24 Week Endpoint in Hemoglobin A1c (HbA1c)

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

percent of HbA1c

Baseline, 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000219 OG001210

Title

Denominators

Categories

Baseline (n=209, n=202)

Title	Measurements
	OG0008.79± 0.06 OG0018.77± 0.06

Change from Baseline (n=209, n=202)

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	Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).	ANCOVA	ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.	0.026		Mean Difference (Net)	-0.21				95	-0.39	-0.03			The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).	Yes

Secondary

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.

Posted

Least Squares Mean

Standard Error

percent hemoglobin

Baseline, 12 Weeks, 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint

Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Number

percentage of participants

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Glycemic Variability

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Mean

Standard Deviation

millimoles per Liter (mmol/L)

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint

Actual daily mean blood glucose levels at endpoint.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.

Posted

Number

participants

Baseline to 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts

Secondary

1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.

Posted

Mean

Standard Deviation

hypoglycemic events per 1 year

Baseline to 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Secondary

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.

Posted

Mean

Standard Deviation

hypoglycemic events per 30 days

Baseline to 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units

Secondary

Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Mean

Standard Deviation

kilograms (kg)

Baseline, 24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Total Daily Insulin Dose (Units) at Endpoint

Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Mean

Standard Deviation

Units of insulin

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint

Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Mean

Standard Deviation

Units of Insulin/kilograms (U/kg)

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Injections of Basal Insulin Analog at Endpoint

Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Posted

Number

participants

24 Weeks

ID	Title	Description
OG000	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
OG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Units	Counts
Participants	OG000

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	Insulin Lispro Protamine Suspension	Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.			7	219	78	219
EG001	Detemir	Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.			1	210	70	210

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected210 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 events2 affected219 at risk EG0010 events0 affected210 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected210 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic retinopathy	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected219 at risk EG0012 events2 affected210 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 events6 affected219 at risk EG0017 events7 affected210 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected219 at risk EG0012 events2 affected210 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events2 affected219 at risk EG0015 events4 affected210 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected219 at risk EG0012 events2 affected210 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0013 events3 affected210 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected219 at risk EG0012 events1 affected210 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected219 at risk EG0013 events3 affected210 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected219 at risk EG0011 events1 affected210 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events2 affected219 at risk EG0013 events3 affected210 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected219 at risk EG0011 events1 affected210 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected219 at risk EG0015 events3 affected210 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00014 events12 affected219 at risk EG00110 events10 affected210 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected219 at risk EG0010 events0 affected210 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 events6 affected219 at risk EG0018 events7 affected210 at risk
Weight increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected219 at risk EG0010 events0 affected210 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0013 events3 affected210 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected219 at risk EG0013 events3 affected210 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected219 at risk EG0013 events3 affected210 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected219 at risk EG0017 events4 affected210 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 events5 affected219 at risk EG0018 events8 affected210 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected219 at risk EG0013 events3 affected210 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected219 at risk EG0014 events4 affected210 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected219 at risk EG0013 events3 affected210 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
C110077	neutral protamine lispro insulin
D061268	Insulin Lispro
D000069057	Insulin Detemir

Ancestor Terms

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

Non-Inferiority or Equivalence

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