NCT00747175CompletedPhase 1
A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Study Overview
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
- •Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
- •HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)
Exclusion Criteria
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
- •History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
- •Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus
Arms & Interventions
1
Experimental
3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)
Intervention: AZD1656 (Drug)
2
Experimental
Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)
Intervention: AZD1656 (Drug)
Outcomes
Primary Outcomes
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary Outcomes
- Pharmacokinetic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
- Pharmacodynamic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
Investigators
Study Sites (1)
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