Evaluate Efficacy, Safety and Tolerability of AZD1656 as... | NCT01020123

Status Module

Oversight 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
1	Experimental	AZD1656	Drug: AZD1656
2	Experimental	AZD1656	Drug: AZD1656
3	Experimental	AZD1656	Drug: AZD1656
4	Experimental	AZD1656	Drug: AZD1656
5	Experimental	AZD1656	Drug: AZD1656
6	Placebo Comparator		Drug: Placebo
7	Active Comparator	Glipizide administered to 1 group of patients

Name	Type	Description	Arm Group Labels	Other Names
AZD1656	Drug	Different doses of AZD1656 administered to 5 groups of patients	1 2 3 4 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c: Change From Baseline to 4 Month	AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue	Baseline to 4th Month

Secondary Outcomes

Measure	Description	Time Frame
FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.	AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.	baseline to 4 month
SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Eva Johnsson	AstraZeneca R&D Mölndal	Study Director
John Wilding, DM FRCP	University Hospital Aintree	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Temuco	Araucania		Chile
Research Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
FG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
BG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
BG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
BG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
BG004	Placebo	Placebo add on to metformin
BG005	Glipizide	5-20 mg Glipizide add on to metformin, titrated dose
BG006	Open Label	Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
BG007	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

Full Range

Year

Title

Denominators

Categories

Title	Measurements
	OG000-1.25± -1.14(-1.49 to -1.01) OG001-1.26± -1.14(-1.49 to -1.02) OG002-0.67± -0.62(-0.99 to -0.36)

Secondary

FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

The population is FAS prior to rescue, using the LOCF values (see table 29 in CSR)

Posted

Mean

95% Confidence Interval

mmol/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo

Secondary

SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

The population is FAS prior to rescue, using the LOCF values (see table 31 in CSR)

Posted

Mean

95% Confidence Interval

mmol/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

OGTT/Plasma Glucose

The relative change in AUC

The population is FAS prior to rescue, using the LOCF values (see table 142 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo

Secondary

OGTT/Insulin

The Relative Change in AUC FAS Prior to Rescue

The population is FAS prior to rescue, using the LOCF values (see table 146 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo

Secondary

OGTT/C-peptide

The relative change, FAS prior to rescue

The population is FAS prior to rescue, using the LOCF values (see table 150 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo

Secondary

OGTT/Pro-insulin/Insulin

The relative change, FAS prior to rescue

The population is FAS prior to rescue, using the LOCF values (see table 154 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol

Posted

Geometric Mean

95% Confidence Interval

Ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004

Secondary

HbA1c ≤ 7

Number of responders ≤ 7, FAS prior to rescue.

The population is FAS prior to rescue, using the observed cases (see table 35 in CSR).

Posted

Number

Participants

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin
OG005

Secondary

HbA1c ≤ 6.5

Number of Responders ≤ 6.5, FAS Prior to Rescue

The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR).

Posted

Number

Participants

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin
OG005

Secondary

LDL-C: Mean Ratio

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR)

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

HDL-C: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

The population is safety analysis set regardless of rescue, using the observed cases (see table 230 in CSR)

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Total Cholesterol: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

The population is safety analysis set regardless of rescue, using the observed cases (see table 232 in CSR)

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Triglycerides: Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 226 in CSR)

Posted

Mean

Standard Deviation

mg/dL

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

C-reactive Protein: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI

The population is safety analysis set regardless of rescue, using the observed cases (see table 234 in CSR)

Posted

Geometric Mean

95% Confidence Interval

ratio

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Systolic Blood Pressure, Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 237 in CSR)

Posted

Mean

Standard Deviation

mmHg

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Diastolic Blood Pressure, Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 240 in CSR)

Posted

Mean

Standard Deviation

mmHg

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Pulse, Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 236 in CSR)

Posted

Mean

Standard Deviation

Beats/min

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Weight, Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 244 in CSR)

Posted

Mean

Standard Deviation

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

QTcF; Electorcardiagram Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 258 in CSR)

Posted

Mean

Standard Deviation

msec

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Haemoglobin; Change From Baseline

Summary statistic of change from baseline

population is safety analysis set regardless of rescue, using the observed cases (see table 197 in CSR)

Posted

Mean

Standard Deviation

g/dL

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Leukocytes; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 198 in CSR)

Posted

Mean

Standard Deviation

*10^3 cells/µL

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Sodium; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 215 in CSR)

Posted

Mean

Standard Deviation

mEq/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Potassium; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 214 in CSR)

Posted

Mean

Standard Deviation

mEq/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Creatinine; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 211 in CSR)

Posted

Mean

Standard Deviation

IU/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

ALT; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 206 in CSR)

Posted

Mean

Standard Deviation

IU/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

AST; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 207 in CSR)

Posted

Mean

Standard Deviation

IU/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Alkaline Phosphatase; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 208 in CSR)

Posted

Mean

Standard Deviation

IU/L

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

Bilirubin; Change From Baseline

Summary statistic of change from baseline

The population is safety analysis set regardless of rescue, using the observed cases (see table 209 in CSR)

Posted

Mean

Standard Deviation

mg/dL

baseline to 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Placebo	Placebo add on to metformin

Secondary

CL/F to Characterise the PK Properties of AZD1656.

The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.

Posted

Mean

Standard Error

L/h

at 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Open Label	Open label, 20-200 mg AZD1656 add on to metformin, titrated dose

Secondary

EC50 to Characterise the PD Properties of AZD1656.

The value is model based. The value is independent treatment given.

Posted

Mean

Standard Error

nmol/L

at 4 month

ID	Title	Description
OG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose
OG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose
OG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose
OG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose
OG004	Open Label	Open label, 20-200 mg AZD1656 add on to metformin, titrated dose

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Higher Dose	20-200 mg AZD1656 add on to metformin, titrated dose	2	92	22	92
EG001	Lower Dose	10-140 mg AZD1656 add on to metformin, titrated dose	1	90	36	90
EG002	40 mg Fixed Dose	40 mg AZD1656 add on to metformin, fixed dose	1	50	20	50
EG003	20 mg Fixed Dose	20 mg AZD1656 add on to metformin, fixed dose	1	40	10	40
EG004	Placebo	Placebo add on to metformin	2	87	14	87
EG005	Glipizide	5-20 mg Glipizide add on to metformin, titrated dose	3	93	35	93
EG006	Open Label	Open label, 20-200 mg AZD1656 add on to metformin, titrated dose	1	71	9	71

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Unstable	Cardiac disorders	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG0031 events1 affected40 at risk EG0040 events0 affected87 at risk EG0050 events0 affected93 at risk EG0060 events0 affected71 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA 10.0	Non-systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Non-systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Diabetic foot	Metabolism and nutrition disorders	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected90 at risk EG0020 events0 affected50 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0021 events1 affected50 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 10.0	Non-systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Anal abscess	Infections and infestations	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Renal failur acute	Renal and urinary disorders	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Non-systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected90 at risk EG0020 events0 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0004 affected92 at risk EG0019 affected90 at risk EG0022 affected50 at risk EG0031 affected40 at risk EG004
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0002 affected92 at risk EG0010 affected90 at risk EG0020 affected50 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0004 affected92 at risk EG0017 affected90 at risk EG0023 affected50 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0002 affected92 at risk EG0012 affected90 at risk EG0024 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0000 affected92 at risk EG0012 affected90 at risk EG0025 affected50 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0001 affected92 at risk EG0011 affected90 at risk EG0021 affected50 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0002 affected92 at risk EG0014 affected90 at risk EG0021 affected50 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0001 affected92 at risk EG0014 affected90 at risk EG0021 affected50 at risk EG003
Tremor	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0004 affected92 at risk EG0014 affected90 at risk EG0021 affected50 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	This iformation is based on tables 182 and 183 in the CSR	EG0002 affected92 at risk EG0013 affected90 at risk EG0022 affected50 at risk EG003

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

ID	Term
D013453	Sulfonylurea Compounds
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals