Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus

NCT02024971 | Completed Results

• 3 other identifiers: 073-011JapicCTI-132368JapicCTI-R150782
• Study Type: observational
• Target: 1,103
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride combined with metformin hydrochloride is considered suitable.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Drug Reactions

  Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

  12 months

Secondary Outcomes (3)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline and Months 3, 6, 9, 12 and final assessment

• Change From Baseline in Fasting Blood Glucose

  Baseline and Months 3, 6, 9, 12 and final assessment

• Change From Baseline in Fasting Insulin

  Baseline and Months 3, 6, 9, 12 and final assessment

Study Arms (1)

Pioglitazone/Metformin Hydrochloride

Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.

Drug: Pioglitazone/metformin hydrochloride

Interventions

Pioglitazone/metformin hydrochloride DRUG

Pioglitazone/metformin hydrochloride combination tablets

Also known as: Metact Combination Tablets

Pioglitazone/Metformin Hydrochloride

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus

You may qualify if:

• Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.

You may not qualify if:

• Patients for whom pioglitazone hydrochloride and metformin hydrochloride are contraindicated.
• Patients with cardiac insufficiency or a history of cardiac insufficiency
• Patients with the following conditions (i) Patients with a history of lactic acidosis (ii) Dialysis patients (including peritoneal dialysis) (iii) Patients with cardiovascular conditions such as shock, cardiac insufficiency, myocardial infarction, and pulmonary embolism; patients with severely impaired pulmonary function; and patients with other conditions fostering susceptibility to hypoxemia (iv) Patients with excessive alcohol consumption (v) Patients with dehydration (vi) Patients with gastrointestinal disorders such as diarrhea and vomiting (vii) Elderly patients
• Patients with renal impairment (including mild renal impairment)
• Patients with hepatic impairment
• Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus
• Patients with severe infection, severe trauma, or pre- and post-operative patients
• Patients who are malnourished, starved, debilitated, or have pituitary gland insufficiency or adrenal gland insufficiency
• Patients with a history of hypersensitivity to the ingredients in Metact Combination Tablets or biguanides
• Pregnant or potentially pregnant women

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda Pharmaceuticals Company Limited

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: December 31, 2013
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 22, 2016
• Results First Posted: November 22, 2016

Record last verified: 2016-09