Phase 3
Completed N=240
A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02324569 ↗Enrolled (actual)
240
Serious AEs
10.6%
Results posted
Feb 2019
Primary outcomePrimary: Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period) — -0.56; 0.07 Percent — 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 This can indicate results are unpublished — a known publication-bias signal.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 purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period) |
-0.56; 0.07 | <0.0001 sig |
| PRIMARY Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II |
51; 59 | — |
| SECONDARY Change From Baseline in HbA1c |
-0.16; 0.01; -0.38; -0.06; -0.50; -0.04 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-10.3; 0.1; -12.6; -4.0; -9.3; -0.9 | — |
| SECONDARY Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I |
-9.5; 0.5; -17.6; 3.5; -28.6; -1.2 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II |
1; 1; 1; 2 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II |
2; 4; 2; 1 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II |
1; 1 | — |
| SECONDARY Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II |
17; 16 | — |
| SECONDARY Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast |
9.7; 5.6; 4.3; -0.9; 1.6; -3.0 | — |
Eligibility Criteria
Inclusion Criteria
Participant eligibility is determined according to the following criteria:
- The participant has a diagnosis of type 2 diabetes mellitus.
- The participant has a fasting C-peptide level 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 Haemoglobin A1c (HbA1c) value of 7.5% or higher but less than 10.0% 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%* (* rounded to one decimal place) of the HbA1c value at the start of the screening period (Week -6).
- The participant has been on a fixed diet and/or exercise therapy (if any) from at least 6 weeks prior to the start of the screening period (Week -6).
- The participant is being treated with insulin preparations alone (≥8 units/day and ≤40 units/day) ** from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen of the insulin preparation.
- The participant on any one of the following insulin monotherapies: mixed (rapid-acting or short-acting insulin containing no more than 30% volume), intermediate-acting, or long-acting soluble insulin preparations
- The participant is deemed appropriate for treatment with a combination of insulin and another antidiabetic drug at the start of the screening period (Week -6) by the investigator or subinvestigator.
- The participants with controlled and stable blood pressure will not need any change in the dose of antihypertensive drugs (including discontinuation and suspension) or additional antihypertensive drugs during the study period as assessed by the investigator or subinvestigator.
- The participant is male or female and 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 subinvestigator, 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
Any participant who meets any of the following criteria will not qualify for entry into the study:
- The participants has clinical manifestations of hepatic impairment [e.g., Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of the screening period (Week -6) or at Week -2 of the screening period].
- The participant has moderate or severe renal impairment or end-stage renal failure [e.g., creatinine clearance (Ccr) <50 mL/min at the start of the screening period (Week -6) or Week -2 of the screening period].
- The participant has any serious cardiac diseases, cerebrovascular disorders, or serious pancreatic or hematological diseases (e.g., participants who require inpatient treatment or are hospitalized for treatment within 24 weeks prior to the start of the screening period).
- The participant has, in the judgment of the investigator or subinvestigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at the start of the screening period (Week - 6) or Week -2 of the screening period.
- The participant has a systolic blood pressure of 180 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher during the screening period.
- The participant is on at least two antidiabetic therapies other than one insulin preparation one day before 6 weeks prior to the start of the screening period (Week -6) (43 days prior to the start of the screening period).
- The participants altered the dose and regimen of their insulin pre
Data sourced from ClinicalTrials.gov (NCT02324569). 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.