Phase 2
Completed N=20
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Type II Diabetes
Source: ClinicalTrials.gov NCT00856908 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Systolic Blood Pressure, Change From Baseline to End of Treatment — 0.4; 5.0 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 Insulin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure, Change From Baseline to End of Treatment |
0.4; 5.0 | — |
| PRIMARY Diastolic Blood Pressure, Change From Baseline to End of Treatment |
3.4; 0.6 | — |
| PRIMARY Pulse, Change From Baseline to End of Treatment |
0.7; -5.4 | — |
| PRIMARY Weight, Change From Baseline to End of Treatment |
-0.54; -1.32 | — |
| PRIMARY Clinically Relevant Change of Laboratory Variables |
0; 0 | — |
| SECONDARY Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656 |
23.49 | — |
| SECONDARY Maximum Plasma Concentration of AZD1656 |
2.415 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration of AZD1656 |
0.500 | — |
| SECONDARY Terminal Elimination Half-life of AZD1656 |
5.239 | — |
| SECONDARY Apparent Oral Clearance of AZD1656 |
9.382 | — |
| SECONDARY P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment |
-7; 4 | — |
| SECONDARY S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment |
-2; -29 | — |
| SECONDARY S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment |
-4; -3 | — |
Eligibility Criteria
Inclusion Criteria
- type II diabetes patients, female with non child-bearing potential
- Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
- HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard).
- FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)
Exclusion Criteria
- History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
- Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.
Data sourced from ClinicalTrials.gov (NCT00856908). 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.