NCT02181842 is a clinical trial of Pioglitazone in Type 2 Diabetes Mellitus, sponsored by Takeda.

Who is sponsoring NCT02181842?

NCT02181842 is sponsored by Takeda.

What drugs are being tested in NCT02181842?

Interventions in NCT02181842: Pioglitazone.

What condition does NCT02181842 study?

NCT02181842 studies Type 2 Diabetes Mellitus.

Is NCT02181842 still recruiting?

NCT02181842 is currently completed. Last updated 16 January 2019.

Are results published for NCT02181842?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-16 · How we verify

NCT02181842

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

Completed Results posted Last updated 16 January 2019

What this trial tests

trial testing Pioglitazone in Type 2 Diabetes Mellitus in 246 participants. Completed in 30 June 2011.

Timeline

26 January 2009

Primary endpoint
30 June 2011

30 June 2011

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	246
Start date	26 January 2009
Primary completion	30 June 2011
Estimated completion	30 June 2011

Drugs / interventions tested

Pioglitazone (pioglitazone) — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Takeda — full company profile →

Who can join

Eligibility, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) Primary · 48 Week

The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level \< 130 mg/dL.

Group	Value	95% CI
Pioglitazone	42.2

Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %) Primary · 48 Week

The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with HbA1c (NGSP) Values \< 6.9 %.

Group	Value	95% CI
Pioglitazone	40.0

Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week Primary · From Baseline, Up to 48 Week

Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is SBP as a one of laboratory parameters.

Group	Value	95% CI
Pioglitazone	-6.9	± 17.89

Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week Primary · From Baseline, Up to 48 Week

Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is DBP as a one of laboratory parameters.

Group	Value	95% CI
Pioglitazone	-5	± 11.96

Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week Primary · From Baseline, Up to 48 Week

Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.

Group	Value	95% CI
Pioglitazone	3.97	± 8.613

Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week Primary · From Baseline, Up to 48 Week

Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.

Group	Value	95% CI
Pioglitazone	-1.85	± 26.076

Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone Primary · From Baseline, Up to 48 Week

The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment. Mean daily dose of pioglitazone at the time of enrollment were categorized into \<15 mg, 15 to \<30 mg, 30 \<45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).

<15 mg

Group	Value	95% CI
Pioglitazone	-0.84	± 1.59

15 to <30 mg

Group	Value	95% CI
Pioglitazone	-0.73	± 0.806

30 <45 mg

Group	Value	95% CI
Pioglitazone	-0.98	± 0.68

Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c Primary · From Baseline, Up to 48 Week

The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment. Levels of HbA1c at the time of enrollment were categorized into \<6.2%, 6.2 to \<6.9%, 6.9 \<7.4%, 7.4 \<8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in \<6.2% and 6.2 to \<6.9% group).

6.9 <7.4%

Group	Value	95% CI
Pioglitazone	-0.36	± 0.504

7.4 <8.4%

Group	Value	95% CI
Pioglitazone	-0.83	± 0.657

8.4% ≤

Group	Value	95% CI
Pioglitazone	-1.17	± 1.194

Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender Primary · From Baseline, Up to 48 Week

The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment. Gender was categorized into male and female.

Male

Group	Value	95% CI
Pioglitazone	-0.59	± 0.729

Female

Group	Value	95% CI
Pioglitazone	-1.11	± 0.911

Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI Primary · From Baseline, Up to 48 Week

The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment. Levels of BMI at the time of enrollment were categorized into \<18.5 kg/m\^2, 18.5 to \<25 kg/m\^2, 25 \<30 kg/m\^2, and 30 kg/m\^2 ≤.

<18.5 kg/m^2

Group	Value	95% CI
Pioglitazone	-0.6	± 0

18.5 to <25 kg/m^2

Group	Value	95% CI
Pioglitazone	-0.73	± 0.85

25 <30 kg/m^2

Group	Value	95% CI
Pioglitazone	-0.81	± 0.776

30 kg/m^2 ≤

Group	Value	95% CI
Pioglitazone	-1.3	± 0.972

Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs Primary · From Baseline, Up to 48 Week

The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment. Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.

Had no Presence of Companion Drugs

Group	Value	95% CI
Pioglitazone	-0.68	± 0.922

Had Presence of Companion Drugs

Group	Value	95% CI
Pioglitazone	-0.8	± 0.8

Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point Primary · Baseline and 48 Week

Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

Baseline

Group	Value	95% CI
Pioglitazone	172.62	± 54.016

48 Week

Group	Value	95% CI
Pioglitazone	147.32	± 43.102

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 48. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pioglitazone

Serious: 16/244 (7%)

Deaths: —

Serious adverse events (17 terms)

Reaction	System	Pioglitazone
Cerebral infarction	Nervous system disorders	—
Pneumonia	Infections and infestations	—
Cerebral haemorrhage	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hypoglycaemia	Metabolism and nutrition disorders	—
Depression	Psychiatric disorders	—
Cerebellar infarction	Nervous system disorders	—
Hydrocephalus	Nervous system disorders	—
Intraventricular haemorrhage	Nervous system disorders	—
Aortic aneurysm	Vascular disorders	—
Fall	Injury, poisoning and procedural complications	—
Femur fracture	Injury, poisoning and procedural complications	—

Other adverse events (2 terms — click to expand)

Reaction	System	Pioglitazone
Weight increased	Investigations	—
Oedema peripheral	General disorders	—

Most-reported serious reactions: Cerebral infarction, Pneumonia, Cerebral haemorrhage, Nasopharyngitis, Urinary tract infection, Lymphoma, Pancreatic carcinoma, Rectal cancer.

Data from ClinicalTrials.gov NCT02181842 adverse events section.

Sponsor's own description

The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pioglitazone

Trials testing the same drug.

NCT07444424 — A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants · Phase 1 · recruiting
NCT06657209 — Normal-weight Diabetes: Adipocyte-directed Therapy with Pioglitazone or Tirzepatide · Phase 4 · not yet recruiting
NCT06246799 — Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes · Phase 3 · recruiting
NCT05753657 — A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients · EARLY_PHASE1 · recruiting
NCT05305287 — Quantifying Hepatic Mitochondrial Fluxes in Humans · Phase 4 · recruiting

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02181842 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 16 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02181842.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing