Long-term Safety Study of Alogliptin Used in Combination... | NCT01318135

ID	Type	Description	Link
JapicCTI-090902	Registry Identifier	JapicCTI
U1111-1119-6196	Registry Identifier	WHO

Status Module

Description Module

Label	Type	Intervention Names
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Active Comparator	Drug: Alogliptin and glimepiride
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Active Comparator	Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Active Comparator	Drug: Alogliptin and metformin
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Active Comparator	Drug: Alogliptin and metformin

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin and glimepiride	Drug	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events.	Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.	52 Weeks.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (Week 8).	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.	Baseline and Week 8.

Eligibility Module

Name	Affiliation	Role
Professor, Diabetes and Endocrine Division	Department of Medicine, Kawasaki Medical School	Study Director

PubMed Identifier	Type	Citation	Retractions
24843617	Derived	Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012 Dec 20;3(6):517-25. doi: 10.1111/j.2040-1124.2012.00226.x. Epub 2012 Jul 12.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group	Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. *for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
BG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
BG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
BG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
BG004	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, Customized

Participants randomized in core phase 2/3 glimepiride add-on study, excluding those randomized to the "glimepiride monotherapy group" was 304. Participants randomized in core phase 2/3 metformin add-on study, excluding those randomized to the "metformin monotherapy group" was 287. The following are included in baseline: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.

Number

participants

Title

Denominators

Categories

Serious Adverse Event

Title	Measurements
	OG00016 OG0013 OG0027 OG003

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 8).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 8.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 12.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 16).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 16.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 20).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 20.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 24).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 24.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 28).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 28.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 32).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 32.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 36).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 36.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 40).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 40.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 44).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 44.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 48).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 48.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 52).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Final Visit).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

percentage of Glycosylated Hemoglobin

Baseline and Final Visit (up to 52).

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Fasting Blood Glucose (Week 8).

The change between the value of fasting blood glucose collected at week 8 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 8.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 12).

The change between the value of fasting blood glucose collected at week 12 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 12.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 16).

The change between the value of fasting blood glucose collected at week 6 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 16.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 20).

The change between the value of fasting blood glucose collected at week 20 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 20.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 24).

The change between the value of fasting blood glucose collected at week 24 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 24.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 28).

The change between the value of fasting blood glucose collected at week 28 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 28.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 32).

The change between the value of fasting blood glucose collected at week 32 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 32.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 36).

The change between the value of fasting blood glucose collected at week 36 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 36.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 40).

The change between the value of fasting blood glucose collected at week 40 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 40.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 44).

The change between the value of fasting blood glucose collected at week 44 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 44.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 48).

The change between the value of fasting blood glucose collected at week 48 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 48.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Week 52).

The change between the value of fasting blood glucose collected at week 52 and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Fasting Blood Glucose (Final Visit).

The change between the value of fasting blood glucose collected at final visit and baseline.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Final Visit (up to Week 52).

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
OG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Secondary

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).

The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 12.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).

The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 24.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).

The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Secondary

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).

The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Values are from the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Final Visit (up to Week 52).

ID	Title	Description
OG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
OG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	16	150	116	150
EG001	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	3	152	134	152
EG002	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	7	142	108	142
EG003	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	5	145	113	145

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0022 affected142 at risk EG0030 affected145 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected152 at risk EG0020 affected142 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected0 at risk EG0020 affected142 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Cerebral circulatory failure	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Gas gangrene	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected0 at risk EG0020 affected142 at risk EG003
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected1 at risk EG0021 affected142 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected150 at risk EG0011 affected152 at risk EG0021 affected142 at risk EG003
Sciatica	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Sudden death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected152 at risk EG0020 affected142 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected152 at risk EG0020 affected142 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0026 affected142 at risk EG0032 affected145 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected150 at risk EG0014 affected152 at risk EG0022 affected142 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected150 at risk EG00111 affected152 at risk EG0029 affected142 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 affected150 at risk EG0015 affected152 at risk EG0020 affected142 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Cataract	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected150 at risk EG0017 affected152 at risk EG0020 affected142 at risk EG003
Chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected150 at risk EG0015 affected152 at risk EG0020 affected142 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected150 at risk EG0017 affected152 at risk EG0027 affected142 at risk EG003
Cystitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 affected150 at risk EG0015 affected152 at risk EG0025 affected142 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected150 at risk EG0011 affected152 at risk EG0021 affected142 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected150 at risk EG0018 affected152 at risk EG0026 affected142 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected150 at risk EG0013 affected152 at risk EG0026 affected142 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0027 affected142 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0007 affected150 at risk EG00112 affected152 at risk EG0020 affected142 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected150 at risk EG0018 affected152 at risk EG0020 affected142 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 affected150 at risk EG0014 affected152 at risk EG0020 affected142 at risk EG003
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0029 affected142 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0022 affected142 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0027 affected142 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected150 at risk EG0018 affected152 at risk EG0020 affected142 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0021 affected142 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00046 affected150 at risk EG00157 affected152 at risk EG00244 affected142 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected150 at risk EG0011 affected152 at risk EG0020 affected142 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected150 at risk EG0014 affected152 at risk EG0020 affected142 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected150 at risk EG00116 affected152 at risk EG0026 affected142 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected150 at risk EG0015 affected152 at risk EG0020 affected142 at risk EG003
White blood cell count increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 affected150 at risk EG0010 affected152 at risk EG0023 affected142 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

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

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals