BI 1356 (Linagliptin) in Combination With Metformin and a... | NCT00602472

ID	Type	Description	Link
2007-002450-28	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
linagliptin 5 mg	Experimental	linagliptin 5 mg once daily	Drug: linagliptin
placebo	Placebo Comparator	placebo matching linagliptin 5 mg tablets	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
linagliptin	Drug	active	linagliptin 5 mg
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c Change From Baseline to Week 24	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.	Baseline and week 24

Secondary Outcomes

Measure	Description	Time Frame
HbA1c Change From Baseline to Week 6	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.	Baseline and week 6
HbA1c Change From Baseline to Week 12

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
Age >/= 18 and </= 80 years at Visit 1a (screening)
BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)
Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Exclusion criteria:

Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
Treatment with insulin within 3 months prior to the date of informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
Pre-menopausal women (last menstruation \

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1218.18.54001 Boehringer Ingelheim Investigational Site		Capital Federal			Argentina
1218.18.54002 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27484756	Derived	Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
23672632	Derived	Zeng Z, Yang JK, Tong N, Yan S, Zhang X, Gong Y, Woerle HJ. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 2013 Jun 4.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Patients randomized to receive treatment with matching placebo
FG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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
	BG00057.6± 9.7 BG00158.3± 9.9 BG00258.1± 9.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000136 BG001421 BG002

Body mass index (BMI) continuous

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00028.16± 4.52 BG00128.38± 4.79 BG002

Glycosylated Hemoglobin A1 (HbA1c)

Mean

Standard Deviation

Percent

Title

Denominators

Categories

Title	Measurements
	BG0008.14± 0.84 BG0018.15± 0.80 BG002

Fasting Plasma Glucose (FPG)

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000162.6± 37.1 BG001159.3± 36.5 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

HbA1c Change From Baseline to Week 24

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.

Posted

Mean

Standard Error

Percent

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000262 OG001778

Title

Denominators

Categories

Title	Measurements
	OG000-0.10± 0.05 OG001-0.72± 0.03

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	Linagliptin vs. Placebo	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.62	Standard Error of the Mean	0.06		95	-0.73	-0.50				No	Superiority or Other

Secondary

HbA1c Change From Baseline to Week 6

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Posted

Mean

Standard Error

Percent

Baseline and week 6

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

HbA1c Change From Baseline to Week 12

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment.

HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.

Posted

Mean

Standard Error

Percent

Baseline and week 12

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

HbA1c Change From Baseline to Week 18

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Posted

Mean

Standard Error

Percent

Baseline and week 18

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

FPG Change From Baseline to Week 24

This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.

Posted

Mean

Standard Error

mg/dL

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

FPG Change From Baseline to Week 6

This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.

Posted

Mean

Standard Error

mg/dL

Baseline and week 6

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

FPG Change From Baseline to Week 12

This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.

Posted

Mean

Standard Error

mg/dL

Baseline and week 12

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

FPG Change From Baseline to Week 18

This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication

This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.

Posted

Mean

Standard Error

mg/dL

Baseline and week 18

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <7.0% at Week 24

The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%

This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).

Posted

Number

percentage of patients

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c < 7.0% at Week 24

This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).

Posted

Number

percentage of patients

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <6.5% at Week 24

The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%

This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).

Posted

Number

percentage of patients

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c<6.5% at Week 24

This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).

Posted

Number

percentage of patients

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24

The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%

The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).

Posted

Number

percentage of patients

Baseline and week 24

ID	Title	Description
OG000	Placebo	Patients randomized to receive treatment with matching placebo
OG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0011 affected792 at risk
Angina unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Myocarditis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Eye swelling	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Ocular hyperaemia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Retinal detachment	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Diverticulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Otitis media chronic	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0011 affected792 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0012 affected792 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0011 affected792 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0011 affected792 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0012 affected792 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Tension headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Ketonuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0010 affected792 at risk
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Circulatory collapse	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected263 at risk EG0011 affected792 at risk
Hypertensive crisis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0012 affected792 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected263 at risk EG0011 affected792 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00012 affected263 at risk EG00141 affected792 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00024 affected263 at risk EG00146 affected792 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00014 affected263 at risk EG00125 affected792 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00023 affected263 at risk EG00144 affected792 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00039 affected263 at risk EG001180 affected792 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011799	Quinazolines

ID	Title	Description
BG000	Placebo	Patients randomized to receive treatment with matching placebo
BG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Patients randomized to receive treatment with matching placebo			10	263	94	263
EG001	Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg			25	792	273	792