Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD1656; Drug: Placebo

• Registration Number: NCT01152385
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-26
• Study First Posted: 2010-06-29
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-07
• Results First Submitted: 2012-07-24
• Results First Submitted QC: 2012-07-24
• Last Update Submitted: 2012-07-24
• Results First Posted: 2012-08-27
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high	AZD1656	AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
Middle	AZD1656	AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
low	AZD1656	AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Haemoglobin A1c (HbA1c)	from baseline to 4 months

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG)	from baseline to 4 months
Number of Responders in Terms of HbA1C ≤ 7%	at 4th month
Number of Responders in Terms of HbA1C ≤ 6.5%	at 4th month
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)	from baseline to 4 months
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)	from baseline to 4 months
Percentage Change in Triglycerides	from baseline to 4 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)	from baseline to 4 months

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan