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

A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152385

Enrollment

224

Registered

2010-06-29

Start date

2010-05-31

Completion date

2011-05-31

Last updated

2012-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, Japanese, phase 2, AZD1656, efficacy, dose regimen, pharmacokinetics

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.

Interventions

DRUGAZD1656

Oral tablet administered twice daily during 4 months

DRUGPlacebo

administered twice daily during 4 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Haemoglobin A1c (HbA1c)	from baseline to 4 months

Secondary

Measure	Time frame
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
Change in Fasting Plasma Glucose (FPG)	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
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)	from baseline to 4 months

Countries

Japan

Participant flow

Recruitment details

Enrollment: 224 Study Start Date: May 2010 Study Completion Date: May 2011 Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Pre-assignment details

Wash-out period for patients treated with anti-diabetes treatment at enrolment.

Participants by arm

Arm	Count
High Dose 200 mg (daily dose)	55
Middle Dose 140 mg (daily dose)	58
Low Dose 80 mg (daily dose)	56
Placebo Placebo	55
Total	224

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	1	1	0	0
Overall Study	Other	4	3	2	3
Overall Study	Protocol Violation	0	0	0	1
Overall Study	Study-specific withdrawal criteria	1	1	2	0
Overall Study	Withdrawal by Subject	3	1	1	1

Baseline characteristics

Characteristic	High Dose	Middle Dose	Low Dose	Placebo	Total
Age Continuous	57 Years STANDARD_DEVIATION 9	55 Years STANDARD_DEVIATION 9	55 Years STANDARD_DEVIATION 10	57 Years STANDARD_DEVIATION 9	56 Years STANDARD_DEVIATION 9
Sex: Female, Male Female	7 Participants	8 Participants	8 Participants	9 Participants	32 Participants
Sex: Female, Male Male	48 Participants	50 Participants	48 Participants	46 Participants	192 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	16 / 55	19 / 58	16 / 56	16 / 55
serious Total, serious adverse events	0 / 22	0 / 23	0 / 28	0 / 23