Trial · NCT02049814

Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes

NCT02049814, Phase 4, Completed, Takeda; results first posted 2019-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes. Trials, record NCT02049814. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02049814

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes
NCT number: NCT02049814
Status: Completed
Phases: Phase 4
Enrollment: 494 participants, actual
Lead sponsor: Takeda
Conditions: Type 2 Diabetes Mellitus
Interventions: Metformin, Voglibose, Acarbose
First posted: 2014-01-30
Last updated: 2019-03-13
Results first posted: 2019-02-04

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Baseline, 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 or final visit relative to baseline.
Secondary	Change From Baseline in HbA1c at Week 6	Baseline and Week 6	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 6 relative to baseline.
Secondary	Change From Baseline in Fasting Blood Glucose Over Time	Baseline, Weeks 6 and 12	The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline.
Secondary	Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time	1 and 2 hours after meal at Baseline, Weeks 6 and 12	The change between the value of glucose after 1 and 2 hours of meal, measured by the meal tolerance test collected at Weeks 6 and 12 or relative to baseline.
Secondary	Change From Baseline in Fasting Insulin at Week 12	Baseline, Week 12	The change between the fasting insulin value collected at week 12 or final visit relative to baseline.
Secondary	Change From Baseline in Postprandial Serum Insulin at Week 12	1 and 2 hours after meal at Baseline and Week 12	The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline.
Secondary	Change From Baseline in Fasting Glucagon at Week 12	Baseline, Week 12	The change between the fasting glucagon value collected at week 12 or final visit relative to baseline.
Secondary	Change From Baseline in Postprandial Serum Glucagon at Week 12	1 and 2 hours after meal at Baseline and Week 12	The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline.
Secondary	Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12	Baseline, Week 12	The change between the value of HOMA-IR collected at Week 12 and HOMA-IR collected at Baseline. HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) \* fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance.
Secondary	Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12	Baseline, Week 12	The change between the value of HOMA-beta cell function collected at Week 12 and HOMA-beta cell function collected at Baseline. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \* insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Baseline, Week 12	Per Protocol Set (PPS) is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	percentage of glycated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Week 6	Baseline and Week 6	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	percentage of glycated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Blood Glucose Over Time	Baseline, Weeks 6 and 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time	1 and 2 hours after meal at Baseline, Weeks 6 and 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Insulin at Week 12	Baseline, Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	μU/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Postprandial Serum Insulin at Week 12	1 and 2 hours after meal at Baseline and Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	μU/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Glucagon at Week 12	Baseline, Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	pg/mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Postprandial Serum Glucagon at Week 12	1 and 2 hours after meal at Baseline and Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	pg/mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12	Baseline, Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	Insulin resistance	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12	Baseline, Week 12	PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.	Percentage beta cell function	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Metformin + Voglibose 0.2 mg		-0.6982	Standard Error 0.0742	percentage of glycated hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Metformin + Acarbose 50 mg		-0.9335	Standard Error 0.0764	percentage of glycated hemoglobin
Change From Baseline in HbA1c at Week 6	Metformin + Voglibose 0.2 mg		-0.4765	Standard Error 0.0605	percentage of glycated hemoglobin
Change From Baseline in HbA1c at Week 6	Metformin + Acarbose 50 mg		-0.631	Standard Error 0.0623	percentage of glycated hemoglobin
Change From Baseline in Fasting Blood Glucose Over Time	Metformin + Voglibose 0.2 mg	Change at Week 6	-0.4234	Standard Error 0.1397	mmol/L
Change From Baseline in Fasting Blood Glucose Over Time	Metformin + Acarbose 50 mg	Change at Week 6	-0.8851	Standard Error 0.1438	mmol/L
Change From Baseline in Fasting Blood Glucose Over Time	Metformin + Voglibose 0.2 mg	Change at Week 12	-0.5041	Standard Error 0.1398	mmol/L
Change From Baseline in Fasting Blood Glucose Over Time	Metformin + Acarbose 50 mg	Change at Week 12	-0.8029	Standard Error 0.1439	mmol/L
Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time	Metformin + Voglibose 0.2 mg	Change at Week 6 (1 hour PPG)	-2.5149	Standard Error 0.2308	mmol/L
Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time	Metformin + Acarbose 50 mg	Change at Week 6 (1 hour PPG)	-3.8557	Standard Error 0.2377	mmol/L

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin + Voglibose 0.2 mg	248
Overall Study	STARTED	Metformin + Acarbose 50 mg	246
Overall Study	Safety Set	Metformin + Voglibose 0.2 mg	248
Overall Study	Safety Set	Metformin + Acarbose 50 mg	245
Overall Study	COMPLETED	Metformin + Voglibose 0.2 mg	219
Overall Study	COMPLETED	Metformin + Acarbose 50 mg	219
Overall Study	NOT COMPLETED	Metformin + Voglibose 0.2 mg	29
Overall Study	NOT COMPLETED	Metformin + Acarbose 50 mg	27

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary tract infection	Infections and infestations	Metformin + Voglibose 0.2 mg	15	248
other	Urinary tract infection	Infections and infestations	Metformin + Acarbose 50 mg	9	245
other	Flatulence	Gastrointestinal disorders	Metformin + Voglibose 0.2 mg	23	248
other	Flatulence	Gastrointestinal disorders	Metformin + Acarbose 50 mg	41	245
serious	Sudden hearing loss	Ear and labyrinth disorders	Metformin + Voglibose 0.2 mg	1	248
serious	Sudden hearing loss	Ear and labyrinth disorders	Metformin + Acarbose 50 mg	0	245
serious	ALT increased	Investigations	Metformin + Voglibose 0.2 mg	0	248
serious	ALT increased	Investigations	Metformin + Acarbose 50 mg	1	245
serious	Abnormal liver function test	Investigations	Metformin + Voglibose 0.2 mg	1	248
serious	Abnormal liver function test	Investigations	Metformin + Acarbose 50 mg	0	245

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin + Voglibose 0.2 mg
Total, all-cause mortality	Metformin + Acarbose 50 mg
Total, other adverse events	Metformin + Voglibose 0.2 mg	38	248
Total, other adverse events	Metformin + Acarbose 50 mg	41	245
Total, serious adverse events	Metformin + Voglibose 0.2 mg	3	248
Total, serious adverse events	Metformin + Acarbose 50 mg	5	245

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Metformin + Voglibose 0.2 mg vs Metformin + Acarbose 50 mg: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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