A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: AZD6370

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690287

D0280C00014

Details and patient eligibility

About

The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.

Enrollment: 24 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
• Diabetes Mellitus diagnosis <5 years

Exclusion criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product
• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups

Part A, arm 1

Experimental group

Description:

1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food

Treatment:

Drug: AZD6370

Drug: AZD6370

Part A, arm 2

Experimental group

Description:

1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food

Treatment:

Drug: AZD6370

Drug: AZD6370

Part B, arm1, 2, and 3

Experimental group

Description:

1. AZD6370 dose x mg o.d. 2. dose x/2 mg b.i.d. 3. dose x/4 mg q.i.d.

Treatment:

Drug: AZD6370

Drug: AZD6370

Part B, arm 4

Experimental group

Description:

4) Placebo

Treatment:

Drug: Placebo