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Trial record 19 of 13800 for:    "Diabetes Mellitus"

An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus (TRACK)

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ClinicalTrials.gov Identifier: NCT02771093
Recruitment Status : Completed
First Posted : May 12, 2016
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Trelagliptin Drug: Alogliptin Phase 4

Detailed Description:
The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : September 8, 2016
Actual Primary Completion Date : April 27, 2017
Actual Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Arm Intervention/treatment
Experimental: Trelagliptin 100 mg group
Trelagliptin 100 mg once weekly taken orally before breakfast
Drug: Trelagliptin
Trelagliptin 100 mg tablet

Experimental: Alogliptin 25 mg group
Alogliptin 25 mg once daily taken orally before breakfast
Drug: Alogliptin
Alogliptin 25 mg tablet




Primary Outcome Measures :
  1. Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values [ Time Frame: Baseline, up to 28 days ]
    Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.


Secondary Outcome Measures :
  1. Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  2. Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  3. Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  4. Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  5. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  6. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  7. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  8. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  9. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  10. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) [ Time Frame: Baseline, up to 28 days ]
  11. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) [ Time Frame: Baseline, up to 28 days ]
  12. Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  13. Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal [ Time Frame: Baseline, up to 28 days ]
  14. Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) [ Time Frame: Baseline, up to 28 days ]
  15. Change From Baseline in Mean 24-hour Blood Glucose Levels [ Time Frame: Baseline, up to 28 days ]
  16. Change From Baseline in Mean Daytime Blood Glucose Levels [ Time Frame: Baseline, up to 28 days ]
  17. Change From Baseline in Mean Nocturnal Blood Glucose Levels [ Time Frame: Baseline, up to 28 days ]
  18. Change From Baseline in AUC for Blood Glucose [ Time Frame: Baseline, up to 28 days ]
  19. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) [ Time Frame: Baseline, up to 28 days ]
  20. SD of 24-hour Blood Glucose Values [ Time Frame: Baseline, up to 28 days ]
  21. Changes From Baseline in the SD of Daytime Blood Glucose Values [ Time Frame: Baseline, up to 28 days ]
  22. Changes From Baseline in the SD of Nocturnal Blood Glucose Values [ Time Frame: Baseline, up to 28 days ]
  23. Number of Participants Reporting One or More Treatment-emergent Adverse Events [ Time Frame: Up to 29 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
  2. Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
  3. Participants diagnosed with type 2 diabetes mellitus.
  4. Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
  5. Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.
  6. Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
  7. Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
  8. Men or women aged 20 years or older at the time of informed consent.

Exclusion Criteria:

  1. Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
  2. Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
  3. Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).
  4. Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).
  5. Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
  6. Participants with a history of gastric or small intestinal resection.
  7. Participants with proliferative diabetic retinopathy.
  8. Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).
  9. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
  10. Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
  11. Participants with any malignant tumors.
  12. Habitual drinkers whose average daily alcohol consumption is > 100 mL.
  13. Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
  14. Participants anticipated to require any prohibited concomitant medications during the study period.
  15. Participants who are day and night lifestyle reversal.
  16. Participants participating in any other clinical studies at the time of informed consent for this study.
  17. Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
  18. Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771093


Locations
Japan
Naka-city, Ibaragi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] February 16, 2017
Statistical Analysis Plan  [PDF] October 25, 2017


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02771093     History of Changes
Other Study ID Numbers: Trelagliptin-4001
U1111-1182-4062 ( Other Identifier: UTN )
JapicCTI-163250 ( Registry Identifier: JapicCTI )
First Posted: May 12, 2016    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Type 2, Diabetes, Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action