Clinical trial NCT01020123: Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
Official title: A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus
metformin
glipizide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c: Change From Baseline to 4 Month
timeFrame: Baseline to 4th Month
Secondary outcomes:
measure: FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
timeFrame: baseline to 4 month
measure: SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
timeFrame: baseline to 4 month
measure: OGTT/Plasma Glucose
timeFrame: baseline to 4 month
measure: OGTT/Insulin
timeFrame: baseline to 4 month
measure: OGTT/C-peptide
timeFrame: baseline to 4 month
measure: OGTT/Pro-insulin/Insulin
timeFrame: baseline to 4 month
measure: HbA1c ≤ 7
timeFrame: baseline to 4 month
measure: HbA1c ≤ 6.5
timeFrame: baseline to 4 month
measure: LDL-C: Mean Ratio
timeFrame: baseline to 4 month
measure: HDL-C: Change From Baseline
timeFrame: baseline to 4 month
measure: Total Cholesterol: Change From Baseline
timeFrame: baseline to 4 month
measure: Triglycerides: Change From Baseline
timeFrame: baseline to 4 month
measure: C-reactive Protein: Change From Baseline
timeFrame: baseline to 4 month
measure: Systolic Blood Pressure, Change From Baseline
timeFrame: baseline to 4 month
measure: Diastolic Blood Pressure, Change From Baseline
timeFrame: baseline to 4 month
measure: Pulse, Change From Baseline
timeFrame: baseline to 4 month
measure: Weight, Change From Baseline
timeFrame: baseline to 4 month
measure: QTcF; Electorcardiagram Change From Baseline
timeFrame: baseline to 4 month
measure: Haemoglobin; Change From Baseline
timeFrame: baseline to 4 month
measure: Leukocytes; Change From Baseline
timeFrame: baseline to 4 month
measure: Sodium; Change From Baseline
timeFrame: baseline to 4 month
measure: Potassium; Change From Baseline
timeFrame: baseline to 4 month
measure: Creatinine; Change From Baseline
timeFrame: baseline to 4 month
measure: ALT; Change From Baseline
timeFrame: baseline to 4 month
measure: AST; Change From Baseline
timeFrame: baseline to 4 month
measure: Alkaline Phosphatase; Change From Baseline
timeFrame: baseline to 4 month
measure: Bilirubin; Change From Baseline
timeFrame: baseline to 4 month
measure: CL/F to Characterise the PK Properties of AZD1656.
timeFrame: at 4 month
measure: EC50 to Characterise the PD Properties of AZD1656.
timeFrame: at 4 month
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Research Site
state: Novena Region
city: Brentwood
country: Chile
facility: Research Site
state: TN
city: Santiago
country: Chile
facility: Research Site
city: Temuco
country: Chile
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
state: SN
city: Brentwood
country: Germany
facility: Research Site
state: TN
city: Aschaffenburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Görlitz
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: St. Laurent
country: Hungary
facility: Research Site
state: QC
city: Balatonfured
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Dunaujvaros
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Szigetvar
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Brentwood
country: Latvia
facility: Research Site
state: TN
city: Daugavpils
country: Latvia
facility: Research Site
city: Jekabpils
country: Latvia
facility: Research Site
city: Jelgava
country: Latvia
facility: Research Site
city: Limbazi
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Talsi
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Brentwood
country: Lithuania
facility: Research Site
state: TN
city: Kaunas
country: Lithuania
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Brentwood
country: Mexico
facility: Research Site
state: TN
city: Meridas
country: Mexico
facility: Research Site
state: Yucatan
city: Merida
country: Mexico
facility: Research Site
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Research Site
city: Chiuahua
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Brentwood
country: Peru
facility: Research Site
state: TN
city: Callao
country: Peru
facility: Research Site
city: Lambayeque
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Trujillo
country: Peru
facility: Research Site
city: Brentwood
country: Poland
facility: Research Site
state: TN
city: Gdansk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Kutno
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Alba Iulia
country: Romania
facility: Research Site
state: Alba
city: Tg Mures
country: Romania
facility: Research Site
state: Mures
city: Brentwood
country: Romania
facility: Research Site
state: TN
city: Galati
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Brentwood
country: Sweden
facility: Research Site
state: TN
city: Huddinge
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Paignton
country: United Kingdom
facility: Research Site
state: Devon
city: Liverpool
country: United Kingdom
facility: Research Site
state: Merseyside
city: St. Laurent
country: United Kingdom
facility: Research Site
state: QC
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: West Bromwich
country: United Kingdom
facility: Research Site
city: West Lothian
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Eva Johnsson
role: STUDY_DIRECTOR
affiliation: University Hospital Aintree
name: John Wilding, DM FRCP
role: PRINCIPAL_INVESTIGATOR
References: