Phase 2
Completed N=224
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
Source: ClinicalTrials.gov NCT01152385 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Change in Haemoglobin A1c (HbA1c) — 0.0; -0.3; 0.1; 0.2 Percentage
Summary
The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Haemoglobin A1c (HbA1c) |
0.0; -0.3; 0.1; 0.2 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
9; 6; 1; 16 | — |
| SECONDARY Number of Responders in Terms of HbA1C ≤ 7% |
7; 16; 7; 1 | — |
| SECONDARY Number of Responders in Terms of HbA1C ≤ 6.5% |
2; 8; 2; 0 | — |
| SECONDARY Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) |
8.9; 7.7; 4.0; 5.8 | — |
| SECONDARY Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) |
8.8; 8.7; 11.6; 8.5 | — |
| SECONDARY Percentage Change in Triglycerides |
10.8; 25.0; 6.7; 18.1 | — |
| SECONDARY Change in High-sensitivity C-reactive Protein (Hs-CRP) |
0.058; 0.021; 0.033; -0.007 | — |
Eligibility Criteria
Inclusion Criteria
- women of non-childbearing potential.
- Provision of informed consent prior to any study specific procedures
- Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)
Exclusion Criteria
- Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
- The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
- Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit
Data sourced from ClinicalTrials.gov (NCT01152385). 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.