Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type II Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Glipizide; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020123

D1020C00009

Details and patient eligibility

About

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients

Enrollment: 530 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female of non-childbearing potential
• Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
• Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2)

Exclusion criteria

• Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
• Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
• Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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530 participants in 7 patient groups, including a placebo group

1

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

2

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

3

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

4

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

5

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

6

Placebo Comparator group

Treatment:

Drug: Placebo

7

Active Comparator group

Description:

Glipizide administered to 1 group of patients

Treatment:

Drug: Glipizide