NCT02098733

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 15, 2016

Completed
Last Updated

April 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 25, 2014

Results QC Date

December 16, 2015

Last Update Submit

March 16, 2016

Conditions

Type 2 Diabetes

Keywords

Pharmacological 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.

    For 12 months

Secondary Outcomes (6)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Baseline, and Months 3, 6, 9, 12 and at Final Assessment

  • Glycosylated Hemoglobin (HbA1c)

    Baseline, and Months 3, 6, 9, 12 and at Final Assessment

  • Change From Baseline in Fasting Blood Glucose Level

    Baseline, Months 3, 6, 9, 12 and at Final Assessment

  • Fasting Blood Glucose Level

    Baseline, Months 3, 6, 9, 12 and at Final Assessment

  • Change From Baseline in Fasting Insulin Level

    Baseline, Months 3, 6, 9, 12 and at Final Assessment

  • +1 more secondary outcomes

Study Arms (1)

Pioglitazone/glimepiride

Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast

Drug: Pioglitazone/glimepiride

Interventions

Pioglitazone/glimepirideDRUG

Pioglitazone/glimepiride combination tablets

Also known as: Sonias combination tablets
Pioglitazone/glimepiride

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes

You may qualify if:

  • Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary

You may not qualify if:

  • (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazoneglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Director
Organization
Takeda
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

March 25, 2014

First Posted

March 28, 2014

Study Start

June 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 15, 2016

Results First Posted

April 15, 2016

Record last verified: 2016-03