Trial · NCT01481116

Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes

NCT01481116, Phase 3, Terminated, Takeda; results first posted 2016-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes. Trials, record NCT01481116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01481116

On this page

Trial

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

Title: Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
NCT number: NCT01481116
Status: Terminated
Phases: Phase 3
Enrollment: 2,454 participants, actual
Lead sponsor: Takeda
Conditions: Diabetes Mellitus, Type 2
Interventions: TAK-875, TAK-875, Glimepiride
First posted: 2011-11-29
Last updated: 2016-06-01
Other registries' IDs: eudract:2011-001731-24
Results first posted: 2016-06-01

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at Weeks 78 and 104	Baseline and Weeks 78 and 104	The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.
Secondary	Percentage of Participants With Hypoglycemia	Day 1 up to Weeks 78 and 104	Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (\<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.
Secondary	Change From Baseline in Body Weight at Weeks 78 and 104	Baseline and Weeks 78 and 104	The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.
Secondary	Change From Baseline in HbA1c at Weeks 26 and 52	Baseline and Weeks 26 and 52	The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.
Secondary	Percentage of Participants With HbA1c <7%	Weeks 26, 52, 78 and 104
Secondary	Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia	Weeks 26, 52, 78 and 104
Secondary	Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104	Baseline and Weeks 26, 52, 78 and 104	The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.

Source ClinicalTrials.gov

Outcomes7

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 HbA1c at Weeks 78 and 104	Baseline and Weeks 78 and 104	Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline assessment.	percentage of glycosylated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Hypoglycemia	Day 1 up to Weeks 78 and 104	Safety analysis set included all participants who received at least 1 dose of double-blind study medication. Participants were analyzed according to the study medication they received.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Body Weight at Weeks 78 and 104	Baseline and Weeks 78 and 104	FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period. Data for body weight was not available at Week 104 due to early termination of the study.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Weeks 26 and 52	Baseline and Weeks 26 and 52	FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.	percentage of glycosylated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <7%	Weeks 26, 52, 78 and 104	FAS included all randomized subjects who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia	Weeks 26, 52, 78 and 104	Data for this outcome measure was not analyzed as prespecified in the protocol.
SECONDARY	Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104	Baseline and Weeks 26, 52, 78 and 104	FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.	milligram per deciliter (mg/dL)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group54

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 HbA1c at Weeks 78 and 104	Glimepiride	Baseline	8.00	Standard Error 0.814	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 25 mg	Baseline	8.01	Standard Error 0.777	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 50 mg	Baseline	7.99	Standard Error 0.792	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	Glimepiride	Change at Week 78	-0.80	Standard Error 0.957	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 25 mg	Change at Week 78	-0.82	Standard Error 0.865	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 50 mg	Change at Week 78	-0.98	Standard Error 0.834	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	Glimepiride	Change at Week 104	NA	Standard Error NA	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 25 mg	Change at Week 104	-1.03	Standard Error 1.159	percentage of glycosylated hemoglobin
Change From Baseline in HbA1c at Weeks 78 and 104	TAK-875 50 mg	Change at Week 104	0.03	Standard Error 0.603	percentage of glycosylated hemoglobin
Percentage of Participants With Hypoglycemia	Glimepiride	Day 1 up to Week 78	30.2		percentage of participants

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Glimepiride	824
Overall Study	STARTED	TAK-875 25 mg	817
Overall Study	STARTED	TAK-875 50 mg	813
Overall Study	Treated	Glimepiride	822
Overall Study	Treated	TAK-875 25 mg	816
Overall Study	Treated	TAK-875 50 mg	813
Overall Study	COMPLETED	Glimepiride	0
Overall Study	COMPLETED	TAK-875 25 mg	0
Overall Study	COMPLETED	TAK-875 50 mg	0
Overall Study	NOT COMPLETED	Glimepiride	824

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events489

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	Diarrhoea	Gastrointestinal disorders	Glimepiride	28	822
other	Diarrhoea	Gastrointestinal disorders	TAK-875 25 mg	35	816
other	Diarrhoea	Gastrointestinal disorders	TAK-875 50 mg	36	813
other	Blood creatine phosphokinase increased	Investigations	Glimepiride	26	822
other	Blood creatine phosphokinase increased	Investigations	TAK-875 25 mg	15	816
other	Blood creatine phosphokinase increased	Investigations	TAK-875 50 mg	17	813
other	Dizziness	Nervous system disorders	Glimepiride	20	822
other	Dizziness	Nervous system disorders	TAK-875 25 mg	16	816
other	Dizziness	Nervous system disorders	TAK-875 50 mg	9	813
other	Nausea	Gastrointestinal disorders	Glimepiride	18	822

1 to 10 of 489Source ClinicalTrials.gov

See all 489 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glimepiride
Total, all-cause mortality	TAK-875 25 mg
Total, all-cause mortality	TAK-875 50 mg
Total, other adverse events	Glimepiride	334	822
Total, other adverse events	TAK-875 25 mg	337	816
Total, other adverse events	TAK-875 50 mg	323	813
Total, serious adverse events	Glimepiride	63	822
Total, serious adverse events	TAK-875 25 mg	41	816
Total, serious adverse events	TAK-875 50 mg	58	813

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30880443	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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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