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

• ClinicalTrials.gov Identifier: NCT01152385
• Recruitment Status: Completed
• First Posted: June 29, 2010
• Results First Posted: August 27, 2012
• Last Update Posted: August 27, 2012
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: June 10, 2010
• First Posted Date: June 29, 2010
• Results First Submitted Date: July 24, 2012
• Results First Posted Date: August 27, 2012
• Last Update Posted Date: August 27, 2012
• Study Start Date: May 2010
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 24, 2012): Change in Haemoglobin A1c (HbA1c) [ Time Frame: from baseline to 4 months ]

Original Primary Outcome Measures (submitted: June 26, 2010)

• Evaluate the change of HbA1c [ Time Frame: Up to 4 months ]
• Evaluate the change of HbA1c [ Time Frame: at 1 month visit ]
• Evaluate the change of HbA1c [ Time Frame: 2 month visit ]
• Evaluate the change of HbA1c [ Time Frame: 3 month visit ]
• Evaluate the change of HbA1c [ Time Frame: 4 month visit ]

Current Secondary Outcome Measures (submitted: July 24, 2012)

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

Original Secondary Outcome Measures (submitted: June 26, 2010)

• Number of participants with adverse events (AE) as a measure of safety and tolerability of AZD1656 [ Time Frame: AEs will be collected at every visit throughout the study up to 4 months ]
• Change of fasting plasma glucose (FPG) and number of responders in terms of HbA1C less than 7% and less than 6.5% Time frame: AEs will be collected at every visit throughout the study up to 4 months [ Time Frame: FPG: from baseline to 4 months. HbA1C: number of responders at 4 months ]
• Change of total Cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HLD), triglycerides, and high-sensitivity C-Reactive protein (hs-CRP) [ Time Frame: From baseline to 4 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• Drug: AZD1656
  Oral tablet administered twice daily during 4 months
• Drug: Placebo
  administered twice daily during 4 months

Study Arms

• Experimental: high
  AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
  Intervention: Drug: AZD1656
• Experimental: Middle
  AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
  Intervention: Drug: AZD1656
• Experimental: low
  AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
  Intervention: Drug: AZD1656
• Placebo Comparator: 4
  Intervention: Drug: Placebo

• Publications *: Kiyosue A, Hayashi N, Komori H, Leonsson-Zachrisson M, Johnsson E. Dose-ranging study with the glucokinase activator AZD1656 as monotherapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Oct;15(10):923-30. doi: 10.1111/dom.12100. Epub 2013 Apr 22.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2011): 224
• Original Estimated Enrollment (submitted: June 26, 2010): 220
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01152385
• Other Study ID Numbers: D1020C00016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AstraZeneca
• Original Responsible Party: MSD, AstraZeneca
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Maria Leonsson-Zachrisson; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: July 2012