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

NCT ID: NCT02771093

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-08
• Study Completion Date: 2017-04-27

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).

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2, Diabetes, Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trelagliptin 100 mg group

Trelagliptin 100 mg once weekly taken orally before breakfast

Group Type: EXPERIMENTAL

Trelagliptin

Intervention Type: DRUG

Trelagliptin 100 mg tablet

Alogliptin 25 mg group

Alogliptin 25 mg once daily taken orally before breakfast

Group Type: EXPERIMENTAL

Alogliptin

Intervention Type: DRUG

Alogliptin 25 mg tablet

Interventions

Trelagliptin

Trelagliptin 100 mg tablet

Intervention Type: DRUG

Alogliptin

Alogliptin 25 mg tablet

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Naka, Ibaragi, Japan

Countries

Japan

References

Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.

Reference Type: DERIVED

PMID: 31562608 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1182-4062

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-163250

Identifier Type: REGISTRY

Identifier Source: secondary_id

Trelagliptin-4001

Identifier Type: -

Identifier Source: org_study_id