Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

NCT00856908 | Completed Phase 2 Results

• 1 other identifier: D1020C00020
• Study Type: interventional
• Target: 20
• 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 Insulin

Conditions

Type II 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 following the morning dose 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 evening dose last day of treatment

• Apparent Oral Clearance of AZD1656

  Measured last day of treatment

Study Arms (2)

1

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

2

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

Tolerable dose given twice daily

1

Placebo DRUG

Tolerable dose given twice daily

2

Eligibility Criteria

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

You may qualify if:

• type II diabetes patients, female with non child-bearing potential
• Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
• HbA1c \<11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard).
• FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

You may not qualify if:

• History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
• Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
• Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chula Vista, California, 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

• Marcus Hompesch, MD

  Profil Institut for Clinical Research Inc.

  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: March 5, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 6, 2012
• Results First Posted: November 26, 2012

Record last verified: 2012-11

Locations

US (1)