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

NCT01020123 | Completed Phase 2 Results

• 1 other identifier: D1020C00009
• Study Type: interventional
• Target: 530
• Locations: 11 countries
• Sites: 77

Brief Summary

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

Conditions

Type II Diabetes Mellitus

Keywords

Type II Diabetes Mellitus; metformin; glipizide

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 4th Month

Secondary Outcomes (29)

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

  baseline to 4 month

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

  baseline to 4 month

• OGTT/Plasma Glucose

  baseline to 4 month

• OGTT/Insulin

  baseline to 4 month

• OGTT/C-peptide

  baseline to 4 month

Study Arms (7)

1

EXPERIMENTAL

AZD1656

Drug: AZD1656

2

EXPERIMENTAL

AZD1656

Drug: AZD1656

3

EXPERIMENTAL

AZD1656

Drug: AZD1656

4

EXPERIMENTAL

AZD1656

Drug: AZD1656

5

EXPERIMENTAL

AZD1656

Drug: AZD1656

6

PLACEBO COMPARATOR

Drug: Placebo

7

ACTIVE COMPARATOR

Glipizide administered to 1 group of patients

Drug: Glipizide

Interventions

AZD1656 DRUG

Different doses of AZD1656 administered to 5 groups of patients

1; 2; 3; 4; 5

Placebo DRUG

AZD1656 placebo and glipizide placebo administered to 1 group of patients

6

Glipizide DRUG

Glipizide administered to 1 group of patients

7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (77)

Research Site

Temuco, Región de la Araucanía, Chile

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Brentwood, TN, Chile

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Santiago, Chile

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Temuco, Chile

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Dresden, Saxony, Germany

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Brentwood, TN, Germany

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Aschaffenburg, Germany

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Berlin, Germany

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Bochum, Germany

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Dortmund, Germany

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Frankfurt, Germany

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Görlitz, Germany

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Hamburg, Germany

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Lübeck, Germany

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Magdeburg, Germany

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Saint Laurent, QC, Hungary

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Balatonfüred, Hungary

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Békéscsaba, Hungary

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Dunaújváros, Hungary

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Eger, Hungary

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Gyula, Hungary

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Kaposvár, Hungary

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Nyíregyháza, Hungary

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Szekszárd, Hungary

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Szigetvár, Hungary

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Zalaegerszeg, Hungary

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Brentwood, TN, Latvia

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Daugavpils, Latvia

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Jelgava, Latvia

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Jēkabpils, Latvia

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Limbaži, Latvia

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Riga, Latvia

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Talsi, Latvia

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Valmiera, Latvia

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Brentwood, TN, Lithuania

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Kaunas, Lithuania

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Aguascalientes, Aguascalientes, Mexico

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Zapopan, Jalisco, Mexico

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Monterrey, Mexico, Mexico

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Cuernavaca, Morelos, Mexico

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Monterrey, Nuevo León, Mexico

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Brentwood, TN, Mexico

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Meridas, Yucatán, Mexico

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Mérida, Yucatán, Mexico

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Chiuahua, Mexico

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San Luis Potosí City, Mexico

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Lima, Lima Province, Peru

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Brentwood, TN, Peru

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Callao, Peru

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Lambayeque, Peru

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Lima, Peru

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Piura, Peru

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Trujillo, Peru

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Brentwood, TN, Poland

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Gdansk, Poland

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Krakow, Poland

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Kutno, Poland

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Wroclaw, Poland

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Alba Iulia, Alba, Romania

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Tg Mures, Mureș County, Romania

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Brentwood, TN, Romania

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Galati, Romania

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Ploieşti, Romania

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Sibiu, Romania

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Timișoara, Romania

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Brentwood, TN, Sweden

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Huddinge, Sweden

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Lund, Sweden

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Paignton, Devon, United Kingdom

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Liverpool, Merseyside, United Kingdom

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Saint Laurent, QC, United Kingdom

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Cardiff, United Kingdom

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Chorley, United Kingdom

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Glasgow, United Kingdom

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Stevenage, United Kingdom

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West Bromwich, United Kingdom

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West Lothian, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656; Glipizide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Eva Johnsson

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

• John Wilding, DM FRCP

  University Hospital Aintree

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 26, 2012
• Results First Posted: November 26, 2012

Record last verified: 2012-11

Locations

DE (11); CL (4); SE (3); PE (7); ME (10); LA (8); RO (7); HU (11); LI (2); PL (5); GB (9)