Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides

Completed

• Conditions: Surveillance

• Registration Number: NCT01964976
• Lead Sponsor: Takeda

Brief Summary

To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.

Detailed Description

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and biguanides in participants with type 2 diabetes mellitus in the routine clinical setting.

Participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. The planned sample size is 1,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-08-31
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1096

Inclusion Criteria

• Participants who did not adequately respond to the following treatment • Treatment with biguanides in addition to diet therapy and exercise therapy

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Exclusion Criteria

• Participants contraindicated for Nesina

  1. Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate].
  2. Participants with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate].
  3. Participants with a history of hypersensitivity to any ingredient of Nesina.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Adverse Drug Reactions	Baseline up to 12 months	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. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Number of Participants Reporting One or More Serious Adverse Drug Reactions	Baseline up to 12 months	Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Blood Glucose	Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)	The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Percentage of Participants of Achieving Objective Glycemic Control	Baseline and final assessment (up to Month 12)	The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0%, \<7.0%, and \<6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Change From Baseline in Fasting Insulin Level	Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)	The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.