Trial · NCT00377676

Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes

NCT00377676, Phase 3, Completed, VeroScience; results first posted 2011-10-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes. Trials, record NCT00377676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377676

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Trial

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

Title: Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
NCT number: NCT00377676
Status: Completed
Phases: Phase 3
Enrollment: 3,095 participants, actual
Lead sponsor: VeroScience
Conditions: Type 2 Diabetes Mellitus
Interventions: Cycloset, Usual Diabetes Therapy plus placebo
First posted: 2006-09-18
Last updated: 2016-06-10
Results first posted: 2011-10-28
Limitations and caveats: Thus HbA1c was only performed on a subset of patients defined as failing (HbA1c \>= 7.5) and who were on oral diabetes medications. Forced titration of study drug may have lead to a greater number of discontinuations.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Subjects Experiencing Serious Adverse Events	From baseline to week 52.	Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.
Secondary	Number of Subjects Experiencing Serious Cardiovascular Adverse Events	Baseline to week 52.	The secondary safety endpoint is number subjects with occurrences of first cardiovascular SAE (myocardial infarction, stroke, in-patient hospitalization for heart failure, angina or revascularization surgery).
Secondary	Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea	Baseline to week 24	Change in HbA1c from baseline to week 24 in subjects failing treatment with metformin plus a sulfonylurea with failure defined as having a baseline HbA1c value of ≥ 7.5%. Change was measured at week 24 after randomization in subjects having no major protocol violations. Change is reported as the absolute difference in % HbA1c.
Secondary	Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.	Baseline to week 24	The difference between Cycloset and placebo in the change in HbA1c from baseline to Week 24 was analyzed for subjects with a baseline HbA1c of ≥ 7.5% who were taking at least one oral hypoglycemia agent (OHA) at baseline. The primary analysis was based on subjects from the evaluable per protocol efficacy (EPPE) analysis set with a secondary analysis using subjects from the intent to treat efficacy (ITTE) analysis set for subjects completing 24 weeks of treatment. Change is reported as the absolute difference in % HbA1c.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Subjects Experiencing Serious Adverse Events	From baseline to week 52.		participants	NUMBER
SECONDARY	Number of Subjects Experiencing Serious Cardiovascular Adverse Events	Baseline to week 52.	intent to treat	Subjects	NUMBER
SECONDARY	Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea	Baseline to week 24	subjects with baseline HbA1c of \>= 7.5 and taking both metformin/sulfonylurea but not insulin. Analysis was conducted for those completing 24 weeks of treatment and on the ITT using the LOCF for those not completing 24 weeks of treatment.	percent	LEAST_SQUARES_MEAN
SECONDARY	Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.	Baseline to week 24	randomized subjects with a baseline HbA1c of \>= 7.5 taking one or two oral diabetes agents (not insulin)	percent	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Subjects Experiencing Serious Adverse Events	Cycloset	176		participants
Subjects Experiencing Serious Adverse Events	Placebo	98		participants
Number of Subjects Experiencing Serious Cardiovascular Adverse Events	Cycloset	31		Subjects
Number of Subjects Experiencing Serious Cardiovascular Adverse Events	Placebo	30		Subjects
Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea	Cycloset	-0.49	Standard Deviation 0.8	percent
Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea	Placebo	-0.04	Standard Deviation 1	percent
Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.	Cycloset	-0.41	Standard Deviation 0.9	percent
Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.	Placebo	0.041	Standard Deviation 1.2	percent

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cycloset	2,054
Overall Study	STARTED	Placebo	1,016
Overall Study	COMPLETED	Cycloset	1,093
Overall Study	COMPLETED	Placebo	694
Overall Study	NOT COMPLETED	Cycloset	961
Overall Study	NOT COMPLETED	Placebo	322

Source ClinicalTrials.gov

Adverse events48

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	Events
other	nausea	Gastrointestinal disorders	Cycloset	661	2,054	661
other	nausea	Gastrointestinal disorders	Placebo	77	1,016	77
other	vomiting	Gastrointestinal disorders	Cycloset	167	2,054	167
other	vomiting	Gastrointestinal disorders	Placebo	32	1,016	32
other	Dizziness	Nervous system disorders	Cycloset	303	2,054	303
other	Dizziness	Nervous system disorders	Placebo	63	1,016	63
other	headache	Nervous system disorders	Cycloset	235	2,054	235
other	headache	Nervous system disorders	Placebo	84	1,016	84
other	Fatigue	General disorders	Cycloset	285	2,054	285
other	Fatigue	General disorders	Placebo	68	1,016	68

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cycloset
Total, all-cause mortality	Placebo
Total, other adverse events	Cycloset	1,611	2,054
Total, other adverse events	Placebo	430	1,016
Total, serious adverse events	Cycloset	176	2,054
Total, serious adverse events	Placebo	98	1,016

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17592632	BACKGROUND	PubMed
20332352	RESULT	PubMed
23316290	DERIVED	PubMed
26060823	DERIVED	PubMed
27687032	DERIVED	PubMed
28374645	DERIVED	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 comparisons2

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

Comparison	Source
Cycloset vs Placebo: Subjects Experiencing Serious Adverse Events	Trial comparisons
Cycloset vs Placebo: serious adverse events	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.

GET https://conductscience.org/api/trials/v1/NCT00377676

GET https://conductscience.org/api/trials/v1/NCT00377676/events?page=2

API reference For AI assistants