A Study of the Safety and Efficacy of Glimepiride, Glicla... | NCT01709305

NCT01709305

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin + Sitagliptin + Glimepiride	Active Comparator	During Phase 2, participants receive up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	Drug: Metformin Drug: Sitagliptin Drug: Glimepiride
Metformin + Sitagliptin + Repaglinide	Experimental	During Phase 2, participants receive up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	Drug: Metformin Drug: Sitagliptin Drug: Repaglinide
Metformin + Sitagliptin + Acarbose	Experimental	During Phase 2, participants receive 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	Drug: Metformin Drug: Sitagliptin Drug: Acarbose
Metformin + Sitagliptin + Gliclazide	Experimental	During Phase 2, participants receive 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	Drug: Metformin Drug: Sitagliptin Drug: Gliclazide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.	Metformin + Sitagliptin + Acarbose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)	HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.	Phase 2 Baseline (Week 20) and Week 44

Secondary Outcomes

Measure	Description	Time Frame
Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)	Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.	Phase 2 Baseline (Week 20), Week 44

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28271251	Result	Xu W, Mu Y, Zhao J, Zhu D, Ji Q, Zhou Z, Yao B, Mao A, Engel SS, Zhao B, Bi Y, Zeng L, Ran X, Lu J, Ji L, Yang W, Jia W, Weng J. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Sci China Life Sci. 2017 Mar;60(3):225-238. doi: 10.1007/s11427-016-0409-7. Epub 2017 Feb 7.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase 1: Sitagliptin + Metformin	During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
FG001	Phase 2: Metformin + Sitagliptin + Glimepiride

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Metformin + Sitagliptin + Gliclazide

Metformin + Sitagliptin + Glimepiride

Metformin + Sitagliptin + Repaglinide

This population includes all participants who enrolled in Phase 1 and were GCP compliant.

ID	Title	Description
BG000	Overall Study	During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).

Units	Counts
Participants	BG0005535

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
	OG000-0.65± 0.84(-0.73 to -0.57) OG001-0.62± 0.84(-0.69 to -0.54) OG002-0.46± 0.83(-0.53 to -0.38)

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 OG002	Pairwise Comparison					Difference in LS Means	0.19			2-Sided	98.34	0.02	0.36					Non-Inferiority or Equivalence	Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.

Secondary

Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)

Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Mean

Standard Deviation

Phase 2 Baseline (Week 20), Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
OG002	Phase 2: Metformin + Sitagliptin + Acarbose

Secondary

Percentage of Participants With Hypoglycemia Events (Phase 2)

Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Number

Percentage of Participants

From Week 20 through Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG002	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).

Secondary

Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)

The percentage of participants with a GI AE of "nausea" was reported.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Number

Percentage of Participants

From Week 20 through Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG002	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG003

Secondary

Percentage of Participants With a GI AE of Vomiting (Phase 2)

The percentage of participants with a GI AE of "vomiting" was reported.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Number

Percentage of Participants

From Week 20 through Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG002	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG003

Secondary

Percentage of Participants With a GI AE of Diarrhea (Phase 2)

The percentage of participants with a GI AE of "diarrhea" was reported.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Number

Percentage of Participants

From Week 20 through Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG002	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG003

Secondary

Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)

The percentage of participants with a GI AE of "abdominal pain" was reported.

All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.

Posted

Number

Percentage of Participants

From Week 20 through Week 44

ID	Title	Description
OG000	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG001	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG002	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1: Sitagliptin + Metformin	During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).	63	5,527	66	5,527
EG001	Phase 2: Metformin + Sitagliptin + Acarbose	During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	11	551	3	551
EG002	Phase 2: Metformin + Sitagliptin + Repaglinide	During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	9	545	33	545
EG003	Phase 2: Metformin + Sitagliptin + Gliclazide	During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	10	550	20	550
EG004	Phase 2: Metformin + Sitagliptin + Glimepiride	During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).	8	549	48	549

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG0030 events0 affected550 at risk EG0041 events1 affected549 at risk
Angina Unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Diabetic Retinopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Entropion	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Optic Ischaemic Neuropathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Pterygium	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gastric Polyps	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gastrointestinal Perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Sudden Death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Diabetic Hepatopathy	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Anal Abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0022 events2 affected545 at risk EG003
Epididymitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Otitis Media	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Pulmonary Tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Spermatic Cord Funiculitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Vestibular Neuronitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Abdominal Injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Meniscus Injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0010 events0 affected551 at risk EG0023 events3 affected545 at risk EG003
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gallbladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Ovarian Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Carotid Arteriosclerosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Cerebral Haematoma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Cerebral Infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0012 events2 affected551 at risk EG0020 events0 affected545 at risk EG003
Lacunar Infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Myasthenia Gravis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Vascular Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Calculus Bladder	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Renal Colic	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Incisional Drainage	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Interventional Procedure	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Essential Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Varicose Ulceration	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Vascular Stent Occlusion	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Liver Abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Parotitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Gouty Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Tongue Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Cerebral Haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0011 events1 affected551 at risk EG0020 events0 affected545 at risk EG003
Diabetic Neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0021 events1 affected545 at risk EG003
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Nephrotic Syndrome	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003
Peripheral Artery Stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected5,527 at risk EG0010 events0 affected551 at risk EG0020 events0 affected545 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment		EG00084 events66 affected5,527 at risk EG0015 events3 affected551 at risk EG00251 events33 affected545 at risk EG00335 events20 affected550 at risk EG00472 events48 affected549 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D008687	Metformin
D000068900	Sitagliptin Phosphate
D020909	Acarbose
C072379	repaglinide
C057619	glimepiride
D005907	Gliclazide

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D014312	Trisaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D013453	Sulfonylurea Compounds
D014508	Urea
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds

OG003-0.69± 0.90(-0.77 to -0.61)

During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.