Phase 4
Completed N=27
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02771093 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values — -7.51; -13.04; -11.76; -15.24 mg/dL
◆ Published Evidence
Emerging
19citations · ~3 / year
A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes.
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).
Linked Publications
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A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values |
-7.51; -13.04; -11.76; -15.24; -11.71; -12.91 | — |
| SECONDARY 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 |
-90.7; -660.1; -241.2; -592.9; -632.2; -375.6 | — |
| SECONDARY 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 |
-203.7; -1052.7; -662.6; -1030.9; -1024.6; -958.9 | — |
| SECONDARY 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 |
-218.5; -981.2; -510.2; -926.1; -886.4; -801.6 | — |
| SECONDARY 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 |
-164.5; -829.2; -377.8; -770.4; -759.4; -609.9 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) |
-1935.9; -4021.4; -2001.2; -3378.3; -2978.2; -4119.9 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) |
-1458.0; -3075.8; -1702.0; -2767.3; -2335.8; -3273.0 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) |
-989.9; -2247.9; -1332.7; -2086.7; -1685.1; -2352.2 | — |
| SECONDARY Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) |
-116.9; -212.5; -105.0; -147.1; -163.8; -166.1 | — |
| SECONDARY Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) |
-134.2; -229.3; -75.0; -173.2; -167.7; -234.3 | — |
| SECONDARY Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) |
-91.2; -210.7; -117.3; -167.1; -167.3; -236.4 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) |
-31.2; 0.4; -43.0; 0.0; -42.3; 13.4 | — |
| SECONDARY Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal |
-11.3; -35.6; -35.4; -29.1; -39.4; -29.0 | — |
| SECONDARY Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal |
-13.9; -28.9; -47.4; -35.4; -41.2; -42.1 | — |
| SECONDARY Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) |
-28.42; -47.25; -33.72; -52.75; -36.08; -44.67 | — |
| SECONDARY Change From Baseline in Mean 24-hour Blood Glucose Levels |
-8.14; -16.77; -8.15; -12.46; -13.12; -15.85 | — |
| SECONDARY Change From Baseline in Mean Daytime Blood Glucose Levels |
-11.08; -20.38; -12.48; -17.21; -18.42; -21.80 | — |
| SECONDARY Change From Baseline in Mean Nocturnal Blood Glucose Levels |
-2.65; -10.69; 0.52; -3.38; -3.17; -3.76 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose |
-2340.4; -4828.9; -2348.4; -3594.8; -3723.2; -4565.6 | — |
| SECONDARY Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) |
-2263.8; -4735.1; -2479.2; -3742.8; -3755.3; -4576.9 | — |
| SECONDARY Standard Deviation (SD) of 24-hour Blood Glucose Values |
38.18; 40.44; 30.68; 27.41; 26.42; 25.20 | — |
| SECONDARY Changes From Baseline in the SD of Daytime Blood Glucose Values |
-9.78; -13.28; -12.82; -13.12; -11.98; -10.98 | — |
| SECONDARY Changes From Baseline in the SD of Nocturnal Blood Glucose Values |
-0.71; -2.45; -3.55; -9.76; -4.06; -7.86 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events |
1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
- Participants participating in any other clinical studies at the time of informed consent for this study.
- Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
- Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.
Data sourced from ClinicalTrials.gov (NCT02771093) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.