To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: AZD5658; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176097

D2920C00001

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

Full description

This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be of non-childbearing potential.
• Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
• Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion criteria

• Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
• Participation in another clinical study during the last 30 days prior to enrollment
• Significant cardiovascular event within the last 6 months prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

24 participants in 1 patient group, including a placebo group

6 - 8 cohorts

Placebo Comparator group

Description:

2 patients in each cohort will receive placebo

Treatment:

Drug: Placebo

Drug: AZD5658