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

NCT02771093 | Completed Phase 4 Results

• 3 other identifiers: Trelagliptin-4001U1111-1182-4062JapicCTI-163250
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2, Diabetes, Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values

  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.

  Baseline, up to 28 days

Secondary Outcomes (23)

• 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

  Baseline, up to 28 days

• 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

  Baseline, up to 28 days

• 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

  Baseline, up to 28 days

• 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

  Baseline, up to 28 days

• Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)

  Baseline, up to 28 days

Study Arms (2)

Trelagliptin 100 mg group

EXPERIMENTAL

Trelagliptin 100 mg once weekly taken orally before breakfast

Drug: Trelagliptin

Alogliptin 25 mg group

EXPERIMENTAL

Alogliptin 25 mg once daily taken orally before breakfast

Drug: Alogliptin

Interventions

Trelagliptin DRUG

Trelagliptin 100 mg tablet

Trelagliptin 100 mg group

Alogliptin DRUG

Alogliptin 25 mg tablet

Alogliptin 25 mg group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
• Participants diagnosed with type 2 diabetes mellitus.
• 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).
• 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.
• Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
• 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.
• Men or women aged 20 years or older at the time of informed consent.

You may not qualify if:

• Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
• 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.
• 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 \[Day -2\]).
• 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 \[Day -2\]).
• Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
• Participants with a history of gastric or small intestinal resection.
• Participants with proliferative diabetic retinopathy.
• 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).
• Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
• Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
• Participants with any malignant tumors.
• Habitual drinkers whose average daily alcohol consumption is \> 100 mL.
• Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
• Participants anticipated to require any prohibited concomitant medications during the study period.
• Participants who are day and night lifestyle reversal.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Naka, Ibaragi, Japan

Location

Related Publications (1)

• 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.

  PMID: 31562608 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptin; 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 (Note: This product was divested to Teijin Pharma Limited in 2023)

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: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: September 8, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: December 12, 2023
• Results First Posted: December 10, 2018

Record last verified: 2023-12

Locations

JP (1)