Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"

NCT02221284 | Completed Results

• 2 other identifiers: 121-016JapicCTI-142609
• Study Type: observational
• Target: 964
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care. \* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.

Conditions

Type 2 Diabetes Mellitus

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had One or More Adverse Reactions

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.

  Up to Month 12

Secondary Outcomes (6)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline, and final assessment point (up to Month 12)

• Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)

  Baseline, and final assessment point (up to Month 12)

• Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)

  Baseline, and final assessment point (up to Month 12)

• Change From Baseline in Laboratory Test Values (Fasting Insulin Level)

  Baseline, and final assessment point (up to Month 12)

• Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])

  Baseline, and final assessment point (up to Month 12)

Study Arms (1)

Alogliptin

Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin tablets

Also known as: Nesina Tablets

Alogliptin

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:

• Type 2 diabetic patients meeting the following criteria are included in this survey:
• Patients who have had an inadequate response to the following medications/therapies:
• Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)\*, in addition to dietary/exercise therapy
• \* For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.

You may not qualify if:

• Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
• Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus \[Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.\]
• Those with severe infections, before or after surgery, or with serious trauma \[Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.\]
• Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

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: August 18, 2014
• First Posted: August 20, 2014
• Study Start: June 30, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 6, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)