Phase 3
Completed N=107
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
Source: ClinicalTrials.gov NCT02512068 ↗Enrolled (actual)
107
Serious AEs
37.9%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in HbA1c at the End of Treatment Period I — -0.71; 0.01 Percent HbA1c — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given); and to evaluate the long-term efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at the End of Treatment Period I |
-0.71; 0.01 | <0.0001 sig |
| PRIMARY Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II |
40; 32 | — |
| PRIMARY Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet |
54; 48 | — |
| SECONDARY Changes From Baseline in HbA1c |
-0.24; 0.05; -0.46; 0.02; -0.64; -0.05 | — |
| SECONDARY Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II |
3; 2; 7; 8; 22; 7 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-12.9; 2.3; -11.3; -2.6; -12.7; -4.3 | — |
| SECONDARY Change From Baseline in Glycoalbumin |
-1.67; 0.10; -2.46; -0.01; -2.69; -0.21 | — |
| SECONDARY Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II |
1; 2 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II |
13; 16; 3; 5; 1; 1 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II |
4; 1; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a diagnosis of type 2 diabetes mellitus.
- The participant has a fasting C-peptide value of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a hemoglobin value of 10.0 g/dL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a Haemoglobin A1c (HbA1c) value of 7.0% or higher but less than 10.0% at Week -2 of the screening period. For participants undergoing hemodialysis (with End-stage Renal Disease [ESRD]), those with a glycoalbumin value of 20% or higher could be enrolled even if their HbA1c value is below 7.0% at Week -2 of the screening period.
- The participant has an HbA1c value difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%* of the HbA1c value at the start of the screening period (Week -6).
The participant has a glycoalbumin difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%* of the glycoalbumin value at the start of the screening period (Week -6).
*: rounded to one decimal place
- The participant has been on a fixed diet and/or exercise therapy (if any) for at least 6 weeks prior to the start of the screening period (Week -6).
- The participant meets any of the following:
- The participant has not received any antidiabetic medications (including insulin preparations) from at least 6 weeks prior to the start of the screening period (Week -6).
- The participant is being treated with one oral hypoglycemic drug* starting from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen.
*: any one of the following medications: mitiglinide calcium hydrate, repaglinide, acarbose, miglitol, or voglibose
- The participant is being treated with one insulin preparation** starting from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen (≤40 units/day) of the insulin preparation.
- Any one of the following insulin monotherapies: mixed (short-acting or rapid-acting insulin containing no more than 30% volume), intermediate-acting, or long-acting soluble insulin preparations
- The participant is not undergoing hemodialysis or peritoneal dialysis and has severe renal impairment [creatinine clearance (Ccr) <30 mL/min at the start of the screening period (Week -6)], or the participant is undergoing hemodialysis and has end-stage renal failure.
- In the opinion of the investigator or sub-investigator, the initiation of hemodialysis or peritoneal dialysis at least within 12 weeks after starting the investigational product is not expected. [in cases where the participant is not undergoing hemodialysis or peritoneal dialysis (patients with severe renal impairment)]
- The participant has been undergoing hemodialysis starting from at least 6 months prior to informed consent and, in the opinion of the investigator or sub-investigator, the participant is clinically stable. [in cases where the participant is undergoing hemodialysis (patient with end-stage renal failure)]
- The participant is male or female and is aged 20 years or older at the time of informed consent.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent until one month after the end of the study.
- In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
Exclusion Criteria
- The participant has clinically evident hepatic impairment [e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of norm
Data sourced from ClinicalTrials.gov (NCT02512068). 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.