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

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ClinicalTrials.gov Identifier: NCT01964976
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date October 15, 2013
First Posted Date October 17, 2013
Results First Submitted Date August 31, 2016
Results First Posted Date April 13, 2017
Last Update Posted Date April 13, 2017
Study Start Date July 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2017)
  • Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 15, 2013)
  • Frequency of Adverse events [ Time Frame: 12 months ]
    The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
  • Change from Baselin in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and 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 month 12 relative to baseline.
Change History Complete list of historical versions of study NCT01964976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 27, 2017)
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 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 [ Time Frame: 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 Blood Glucose [ Time Frame: 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 Fasting Insulin Level [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: October 15, 2013)
Change from Baselin in Fasting blood glucose [ Time Frame: Baseline and month 12 ]
The change in the value of fasting blood glucose collected at month 12 relative to baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Official Title Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with type 2 diabetes mellitus who have been examined at a medical institution
Condition Surveillance
Intervention Not Provided
Study Groups/Cohorts Alogliptin + Biguanides
All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2014)
1096
Original Estimated Enrollment
 (submitted: October 15, 2013)
1000
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01964976
Other Study ID Numbers 121-014
JapicCTI-132282 ( Registry Identifier: JapicCTI )
JapicCTI-R150790 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Chair: Postmarketing Group Manager Takeda
PRS Account Takeda
Verification Date February 2017