Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

NCT00817778 | Completed Phase 2 Results

• 1 other identifier: D1020C00019
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 Metformin

Conditions

Type 2 Diabetes

Keywords

Type II Diabetes

Outcome Measures

Primary Outcomes (5)

• Systolic Blood Pressure, Change From Baseline to End of Treatment

  Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period

• Diastolic Blood Pressure, Change From Baseline to End of Treatment

  Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period

• Pulse, Change From Baseline to End of Treatment

  Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period

• Weight, Change From Baseline to End of Treatment

  Baseline is the day before first dose, end of treatment is last day of treatment

• Clinically Relevant Change of Laboratory Variables

  Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters

  Measured regularly from day before first dose to day after last dose

Secondary Outcomes (8)

• Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656

  Measured last day of treatment

• Maximum Plasma Concentration of AZD1656

  Measured last day of treatment

• Time to Reach Maximum Plasma Concentration of AZD1656

  Measured last day of treatment

• Terminal Elimination Half-life of AZD1656

  Measured following the afternoon dose last day of treatment

• Apparent Oral Clearance of AZD1656

  Measured last day of treatment

Study Arms (2)

AZD1656

EXPERIMENTAL

Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days

Drug: AZD1656

Placebo

PLACEBO COMPARATOR

Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days

Drug: Placebo

Interventions

AZD1656 DRUG

Subjects will be treated with tolerable dose twice daily for another 24 days.

AZD1656

Placebo DRUG

Subjects will be treated with tolerable dose twice daily for another 24 days.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
• Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
• HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard)

You may not qualify if:

• History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
• Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The primary objective of the study was to assess safety and tolerability and hence the study was not sized based on statistical considerations. The most import outcome, "no safety or tolerability concerns were identified", is not a numerical variable

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Klas Malmberg, MD, PhD, Prof

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

• Emanuel P DeNoia, M.D

  Healthcare Discoveries LLC Icon Development Solutions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 16, 2012
• Results First Posted: November 16, 2012

Record last verified: 2012-10

Locations

US (1)