Phase 2
Completed N=27
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Source: ClinicalTrials.gov NCT00817778 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Nov 2012
Primary outcomePrimary: Systolic Blood Pressure, Change From Baseline to End of Treatment — -0.5; 9.2 mmHg
Summary
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure, Change From Baseline to End of Treatment |
-0.5; 9.2 | — |
| PRIMARY Diastolic Blood Pressure, Change From Baseline to End of Treatment |
-0.2; 2.0 | — |
| PRIMARY Pulse, Change From Baseline to End of Treatment |
2.7; -1.6 | — |
| PRIMARY Weight, Change From Baseline to End of Treatment |
0.2; 0.0 | — |
| PRIMARY Clinically Relevant Change of Laboratory Variables |
0; 0 | — |
| SECONDARY Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656 |
23.17 | — |
| SECONDARY Maximum Plasma Concentration of AZD1656 |
1.90 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration of AZD1656 |
0.625 | — |
| SECONDARY Terminal Elimination Half-life of AZD1656 |
7.07 | — |
| SECONDARY Apparent Oral Clearance of AZD1656 |
9.02 | — |
| SECONDARY P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment |
75.85; 99.42 | — |
| SECONDARY S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment |
103.81; 86.06 | — |
| SECONDARY S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment |
103.60; 98.01 | — |
Eligibility Criteria
Inclusion Criteria
- Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
- Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
- HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)
Exclusion Criteria
- History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
Data sourced from ClinicalTrials.gov (NCT00817778). 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.