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

Phase 2CompletedNCT01020123

AstraZeneca530 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

530

Conditions

Type II Diabetes Mellitus

Interventions

AZD1656DRUG

Different doses of AZD1656 administered to 5 groups of patients

PlaceboDRUG

AZD1656 placebo and glipizide placebo administered to 1 group of patients

GlipizideDRUG

Glipizide administered to 1 group of patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (77)

Outcomes

Primary Outcomes

HbA1c: Change From Baseline to 4 Month

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue

Time frame: Baseline to 4th Month

Secondary Outcomes

FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

Time frame: baseline to 4 month

SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

Time frame: baseline to 4 month

OGTT/Plasma Glucose

The relative change in AUC

Time frame: baseline to 4 month

OGTT/Insulin

The Relative Change in AUC FAS Prior to Rescue

Time frame: baseline to 4 month

OGTT/C-peptide

The relative change, FAS prior to rescue

Time frame: baseline to 4 month

OGTT/Pro-insulin/Insulin

The relative change, FAS prior to rescue

Time frame: baseline to 4 month

HbA1c ≤ 7

Number of responders ≤ 7, FAS prior to rescue.

Time frame: baseline to 4 month

Data from ClinicalTrials.gov

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Research Site

Temuco, Araucania, Chile

Research Site

Brentwood, TN, Chile

Research Site

Santiago, Chile

Research Site

Temuco, Chile

Research Site

Dresden, Saxony, Germany

Research Site

Brentwood, TN, Germany

Research Site

Aschaffenburg, Germany

Research Site

Berlin, Germany

Research Site

Bochum, Germany

Research Site

Dortmund, Germany

...and 67 more locations

HbA1c ≤ 6.5

Number of Responders ≤ 6.5, FAS Prior to Rescue

Time frame: baseline to 4 month

LDL-C: Mean Ratio

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

Time frame: baseline to 4 month

HDL-C: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

Time frame: baseline to 4 month

Total Cholesterol: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

Time frame: baseline to 4 month

Triglycerides: Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

C-reactive Protein: Change From Baseline

Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI

Time frame: baseline to 4 month

Systolic Blood Pressure, Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Diastolic Blood Pressure, Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Pulse, Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Weight, Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

QTcF; Electorcardiagram Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Haemoglobin; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Leukocytes; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Sodium; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Potassium; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Creatinine; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

ALT; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

AST; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Alkaline Phosphatase; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

Bilirubin; Change From Baseline

Summary statistic of change from baseline

Time frame: baseline to 4 month

CL/F to Characterise the PK Properties of AZD1656.

The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.

Time frame: at 4 month

EC50 to Characterise the PD Properties of AZD1656.

The value is model based. The value is independent treatment given.

Time frame: at 4 month